Professional Documents
Culture Documents
978 1 58528 685 0 Front 1
978 1 58528 685 0 Front 1
Injectable Drug
Information TM
A Comprehensive Guide
to Compatibility and Stability
2021
10 9 8 7 6 5 4 3 2 1
TABLE OF CONTENTS
Preface.........................................................................................................................................................................vii
How to Use ASHP® Injectable Drug Information™ ................................................................................................. ix
AHFS® Pharmacologic-Therapeutic Classification©................................................................................................ xx
Drug Monographs............................................................................................................................ 1
References...............................................................................................................................................................1631
Index........................................................................................................................................................................1723
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PREFACE vii
PREFACE
ASHP® Injectable Drug Information™ 2021 is a collec- mation to the benefit of patients. With increasingly com-
tion of compatibility and stability information on par- plex drug therapy regimens, an abundance of new drug
enteral drug products and is the most recent contribu- and drug formulation approvals, and ever-present drug
tion to this continuing series. With its publication, all shortage issues, pharmaceutics research has important
previous editions are considered out of date. implications for patient care in the inpatient, specialty
One of the core focuses of ASHP as a professional pharmacy, and home infusion settings. Recent exam-
and scientific society has been its long history of pub- ples of inappropriate compounding practices involving
lishing internationally recognized, authoritative sources parenteral medications have resulted in increased sterile
of drug information. Beginning with publication of the compounding regulation and have reinforced the impor-
Society’s ground-breaking work the American Hospital tance of adherence to sterile compounding standards,
Formulary Service® (AHFS®; now AHFS Drug Information®) implementation of best practices in the preparation
in 1959 and continuing with the definitive works the and administration of parenteral drug products (com-
Parenteral Drug Information Guide™ in 1974, the Hand- mercially available or extemporaneously compounded),
book on Injectable Drugs® in 1977, and the Medication and application of principles and findings of pharmaceu-
Teaching Manual® (now AHFS Patient Medication Infor- tics research to patient care. For additional information
mation™) in 1978, ASHP has consistently set the stan- on sterile compounding, ASHP’s Resource Center can be
dard for objective drug information focused on safe and consulted (www.ashp.org/sterilecompounding).
effective drug therapy. For more than 75 years, ASHP has Beginning with the 18th edition, the Handbook on
been at the forefront of efforts to improve medication Injectable Drugs® became an integral component of
use and patient safety. Publication of ASHP® Injectable ASHP’s AHFS® resource collection of authoritative drug
Drug Information™ 2021 is an important component of information. Applying its expansive drug information
those efforts. With the 2021 edition of ASHP® Injectable and informatics expertise, ASHP’s focus with the subse-
Drug Information™, ASHP marks 49 years of publishing quent editions has been on the continuing addition and
such an invaluable resource on parenteral medications. revision of new and existing drug monographs as well as
First published in 1977 as a key outgrowth of phar- important database enhancements to this indispensable
maceutics research and pharmacy practice at the US authority on parenteral drugs. ASHP® Injectable Drug
Public Health Service and National Institutes of Health Information™ 2021, which was begun to provide a single
(NIH), the Handbook on Injectable Drugs® has a long leg- standardized source of the primary research on the sta-
acy of translating pharmaceutics research into an essen- bility, compatibilities, and incompatibilities of injectable
tial resource for practical patient-care applications. Law- drugs, continues to be the most widely recognized “Gold
rence A. Trissel, who served as co-author of ASHP’s first Standard” for such information.
resource on injectable drugs—the Parenteral Drug Infor- ASHP® Injectable Drug Information™ 2021 includes
mation Guide™, established this legacy by serving as 18 new monographs, bringing the total in this edition
the distinguished author of the Handbook on Injectable to 406 monographs on parenteral drugs available in the
Drugs® for the first 17 editions. ASHP and the profession United States and in other countries. In addition, more
as a whole remain grateful to Mr. Trissel for his contribu- than 500 revisions to existing monographs (affect-
tion to the pharmaceutics literature and his unyielding ing nearly 60% of the existing monographs) have been
dedication to the science of stability and compatibility accomplished to update information on stability, com-
information on parenteral products. patibility, and safety (e.g., Food and Drug Administra-
With the publication of the Mirror to Hospital Phar- tion [FDA] MedWatch alerts) and to provide more spe-
macy in 1964, ASHP paved the way for a transition from cific referencing of manufacturer information and other
nursing-driven to pharmacy-led sterile compounding enhancements to the more than 24,100 compatibility
services and has remained an industry leader for both pairs contained in ASHP® Injectable Drug Information™
advocacy and best practices related to parenteral med- 2021. The information cited throughout the text has
ications. The mission of ASHP’s reference publications been compiled from 3603 references, including 195 new
on compatibility and stability of parenteral products to this edition. Because information from pharmaceuti-
has always been to facilitate the use of the vast body of cal manufacturers had not been uniquely cited until the
pharmaceutics research on parenteral medications in a 18th edition, the number of unique references supporting
way that could enable those who prescribe, prepare, and ASHP® Injectable Drug Information™ 2021 information
administer injectable drugs to more fully apply this infor- actually greatly exceeds this number. While primary,
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viii ASHP INJECTABLE DRUG INFORMATION
peer-reviewed literature remains a major source of com- Regular updates, FDA MedWatch alerts and other
patibility and stability information, ongoing efforts are guidances, and wall-chart custom views of compatibility
underway to provide increased specificity of references information continue to be available for digital versions.
to the pharmaceutics research of drug manufacturers. For proper use of this reference work, the reader
Other relevant information and pertinent study details must review “How to Use ASHP® Injectable Drug Infor-
supplied by corresponding authors of the published liter- mation™,” which immediately follows this Preface. This
ature also have been incorporated when available. section will acquaint the user of ASHP® Injectable Drug
In addition to the noted enhancements to the 2021 Information™ with its organization, content, structure,
print edition of ASHP® Injectable Drug Information™ summarization strategy, interpretation of the informa-
2021, the regularly updated online edition features linked tion presented, and limitations of the published litera-
monographs to Extended Stability for Parenteral Drugs, ture upon which this reference text is based. Without a
forming a single, comprehensive resource on inject- good working knowledge of these points, ASHP® Inject-
able drug information. This extended stability informa- able Drug Information™ 2021 may not be used to its best
tion is specifically designed for use in home infusion and advantage or even interpreted correctly.
other infusion practices, providing critical stability data
to support realistic and cost-effective compounding and
patient delivery schedules. ASHP® Injectable Drug Infor-
mation™ 2021 also will soon be available as an ebook
in a variety of formats (e.g., PDF, EPUB, full-text HTML).
USERS GUIDE
teral drugs should seek the assistance of more knowl-
HOW TO USE ASHP INJECTABLE ® edgeable and experienced healthcare professionals to
DRUG INFORMATION™ ensure patient safety.
Users of ASHP® Injectable Drug Information™ must
What Is ASHP® Injectable Drug recognize that no reference work, including this one, can
Information™ ? substitute for adequate decision-making by healthcare
professionals. Proper clinical decisions must be made
ASHP® Injectable Drug Information™ is a collection of after considering all aspects of the patient’s condition and
summaries of information from the published litera- needs, with particular attention to the special demands
ture on the pharmaceutics of parenteral medications imposed by parenteral medications. ASHP® Injectable
as applied to the clinical setting. ASHP® Injectable Drug Drug Information™ cannot make decisions for its users.
Information™ is constructed from information derived However, in knowledgeable hands, it is a valuable tool
from 3603 references with the information presented in for the proper use of parenteral medications.
the standardized structure described below. The purpose
of this reference text is to facilitate the use of this clinical Organization of ASHP® Injectable
pharmaceutics research by knowledgeable health care Drug Information™
professionals for the benefit of patients. The summary
information from published research is supplemented ASHP® Injectable Drug Information™ has been organized
with information from the labeling of each product and as a collection of monographs on each of the drugs. The
from other references. monographs are arranged alphabetically by nonpropri-
The information base summarized in ASHP® Inject- etary (generic) name. The nonproprietary names of the
able Drug Information™ is large and highly complex, drugs are the United States Adopted Names (USAN)
requiring thoughtful consideration for proper use. This and other official names for drugs as described in the
reference text is not, nor should it be considered, ele- USP Dictionary of USAN and International Drug Names.
mentary in nature or a primer. A single quick glance in Also included are some of the trade (proprietary, brand)
a table is not adequate for proper interpretation of this names and manufacturers of the drug products; this list-
highly complex information base. Proper interpretation ing is not necessarily comprehensive and should not be
includes the obvious need to consider and evaluate all considered an endorsement of any product or manufac-
relevant research information and results. Additionally, turer.
information on the formulation components (e.g., excip- All of the information included in ASHP® Injectable
ients), product attributes (especially pH), and the known Drug Information™ is referenced so that those who wish
stability behaviors of each parenteral drug, as well as the to study the original sources may find them. Efforts are
clinical situation of the patient, must be included in a ongoing to provide increased specificity of references to
thoughtful, reasoned evaluation of clinical pharmaceu- product labeling as individually cited references to the
tics questions. Stability and sterility both must be con- labeling for a drug product, including the proprietary
sidered in the assignment of beyond-use dates. name (if available), manufacturer, and revision date of
the prescribing information; this will facilitate location
Who Should Use ASHP® Injectable of specific labeling that has been used as a reference. In
Drug Information™? addition, the full list of the AHFS® Pharmacologic-Ther-
apeutic Classification© system and specific classification
ASHP® Injectable Drug Information™ is designed for use numbers within each individual monograph have been
as a professional reference and guide to the literature included to facilitate the location of therapeutic infor-
on the clinical pharmaceutics of parenteral medica- mation on the drugs.
tions. The intended audience consists of knowledge-
able healthcare professionals, particularly pharmacists, The monographs have been divided into the sub-
who are well versed in the formulation and clinical use headings described below:
of parenteral medications and who have the highly Products—lists many of the sizes, strengths, volumes,
specialized knowledge base, training, and skill set nec- and forms in which the drug is supplied, along with
essary to interpret and apply the information. Prac- other components of the formulation. Instructions
titioners who are not well versed in the formulation, for reconstitution (when applicable) are included in
essential properties, and clinical application of paren- this section.
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x ASHP INJECTABLE DRUG INFORMATION
The products described do not necessarily comprise Protection from excessive heat is often required; exces-
a comprehensive list of all available products. Rather, sive heat is defined as any temperature above 40°C.17
some common representative products are described. Similarly, protection from freezing may be required
Furthermore, dosage forms, sizes, and container con- for products that are subject to loss of strength or
figurations of parenteral products may undergo potency or to destructive alteration of their charac-
important changes during the lifespan of this edition teristics, in addition to the risk of container breakage,
of ASHP® Injectable Drug Information™. upon exposure to freezing temperatures.17
Following the product descriptions, the pH of the Some products may require storage at a cool tempera-
drug products, the osmotic value(s) of the drug and/ ture, which is defined as any temperature between
or dilutions (when available), and other product infor- 8–15°C, or a cold temperature, which is defined as
mation such as the sodium content and definition of any temperature not exceeding 8°C.17 A refrigerator
units are presented. is defined as a cold place in which the temperature
Practitioners have not always recognized the value is controlled between 2–8°C.17 A freezer refers to a
and importance of incorporating product formula- place in which the temperature is controlled between
tion information into the thought process that leads -25 and -10°C.17 Some products may have a recom-
to their decision on handling drug compatibility mended storage condition below -20°C, and in such
and stability questions. Excipients used in the for- cases, the temperature should be controlled to with-
mulation of commercially available products may in 10°C of -20°C.17
vary among manufacturers and can influence drug In addition to storage requirements, aspects of
compatibility and stability; specific product label- drug stability related to pH, freezing, and expo-
ing should be consulted for additional formulation sure to light are presented in this section. Also pre-
details. Consideration of the product information sented is information on repackaging of the drugs
and formulation components, as well as the proper- or their dilutions in container/closure systems other
ties and attributes of the products (especially pH), is than the original package (e.g., prefilling into syring-
essential to proper interpretation of the information es or in ambulatory pump reservoirs). Sorption and
presented in ASHP® Injectable Drug Information™. filtration characteristics of the drugs are provided as
well when this information is available. The informa-
Administration—includes route(s) by which the drug
tion is derived principally from the primary published
can be given, rates of administration (when applica-
research literature and is supplemented with infor-
ble), and other related administration details.
mation from other sources when available.
The administration information is a condensation
derived principally from product labeling. For com- Compatibility Information—tabulates the compatibili-
plete information, including dosage information suf- ty results of the drug about which the monograph
ficient for prescribing, the reader should refer to is written with infusion solutions and other drugs
product labeling and therapeutically comprehensive based on published reports from the primary research
references, such as the AHFS® Drug Information®. as well as the product labeling. The various entries
are listed alphabetically by solution or drug name; the
Stability—describes the drug’s stability and storage information is completely cross-referenced among
requirements. The storage condition terminology of the monographs.
The United States Pharmacopeia, 42nd ed., is used in
Four types of tables are utilized to present the avail-
ASHP® Injectable Drug Information™.
able information, depending on the kind of test
The United States Pharmacopeia defines controlled being reported. The first type is for information on
room temperature as a temperature that encom- the compatibility of a drug in various infusion solu-
passes the usual and customary working environ- tions and is depicted in Table 1. The second type of
ment of 20–25°C and that results in a mean kinet- table presents information on two or more drugs in
ic temperature no greater than 25°C.17 Temperature intravenous solutions and is shown in Table 2. The
excursions between 15–30°C that are experienced in third type of table is used for tests of two or more
pharmacies, hospitals, warehouses, and during ship- drugs in syringes and is shown in Table 3. The fourth
ping are permitted.17 Transient temperature eleva- table format is used for reports of simulated or actu-
tions up to 40°C also are permitted provided that al injection into Y-sites and manifolds of administra-
they do not persist beyond 24 hours and that the tion sets and is shown in Table 4.
mean kinetic temperature does not exceed 25°C.17 In
Many published articles, especially older ones, do not
contrast, room (ambient) temperature is defined sim-
include all of the information necessary to complete
ply as a temperature prevailing in a working environ-
the tables. However, the tables have been complet-
ment.17
ed as fully as possible from the original articles; in
conditions was reported (time periods of less than 24 The reader must guard against misinterpretation
hours have been noted in the table). of research results, which may lead to inappropriate
Reports of test results that do not clearly fit into the assumptions of compatibility and stability. As an exam-
compatibility or incompatibility definitions cannot be ple, a finding of precipitate formation two hours after
designated as either. These are indicated with a question two drugs are mixed does not imply nor should it be
mark. interpreted to mean that the combination is compatible
until that time point, when a sudden precipitation occurs.
Although these criteria have become the conven-
Rather, it should be interpreted to mean that precipita-
tional definitions of compatibility and incompatibility,
tion occurred at some point between mixing and the first
the reader should recognize that the criteria may need
observation point at two hours. Such a result would lead
to be tempered with professional judgment. Inflexible
to a designation of incompatibility in ASHP® Injectable
adherence to the compatibility designations should be
Drug Information™.
avoided. Instead, they should be used as aids in the exer-
cising of professional judgment. Precipitation reports can be particularly troublesome
for practitioners to deal with because of the variability
Therapeutic incompatibilities or other drug interac-
of the time frames in which they may occur. Apart from
tions are not within the scope of ASHP® Injectable Drug
combinations that repeatedly result in immediate pre-
Information™ and are therefore not addressed. Thera-
cipitation, the formation of a precipitate can be unpre-
peutically comprehensive references and the product
dictable to some degree. Numerous examples of variable
labeling should be consulted for such information.
precipitation time frames can be found in the literature,
Interpreting Compatibility including paclitaxel, etoposide, and sulfamethoxaz-
ole-trimethoprim (co-trimoxazole) in infusion solutions
Information in ASHP® Injectable Drug and calcium and phosphates precipitation in parenteral
Information™ nutrition mixtures (e.g., TNAs, TPNs). Differing drug
As mentioned above, the body of information summa- concentrations also can play a role in creating variabil-
rized in ASHP® Injectable Drug Information™ is large and ity in results. A good example of this occurs with co-ad-
complicated. With the possible exception of a report ministered vancomycin hydrochloride and beta-lactam
of immediate gross precipitation, it usually takes some antibiotics. Users of the information in ASHP® Injectable
degree of thoughtful consideration and judgment to Drug Information™ must always be aware that a margin-
properly evaluate and appropriately act on the research ally incompatible combination might exhibit precipita-
results that are summarized in this book. tion earlier or later than that reported in the literature.
In many such cases, the precipitation is ultimately going
Nowhere is the need for judgment more obvious than
to occur, it is just the timing that is in question. This is of
when apparently contradictory information appears in
particular importance for precipitate formation because
two or more published reports. The body of literature in
of the potential for serious adverse clinical consequences,
drug-drug and drug-solution compatibility is replete with
including death, that have occurred. Certainly, users of
apparently contradictory results. Except for study results
ASHP® Injectable Drug Information™ information should
that have been documented later to be incorrect, the con-
always keep in mind and anticipate the possibility of pre-
flicting information has been included in ASHP® Injectable
cipitation and its clinical ramifications. Furthermore, all
Drug Information™ to provide practitioners with all of the
injections and infusions should be inspected for particu-
information for their consideration. The conflicting infor-
late matter and discoloration prior to administration. If
mation will be readily apparent to the reader because of
found, such injections and solutions should be discarded.
the content of the Remarks section as well as the C, I, and
? designations following each citation. In addition, many research reports cite test solutions
or concentrations that may not be appropriate for clin-
Many or most of the apparently conflicting citations
ical use. An example would be a report of a drug’s sta-
may be the result of differing conditions or materials
bility in unsterile water. Although the ASHP® Injectable
used in the studies. A variety of factors that can influence
Drug Information™ summary will accurately reflect the
the compatibility and stability of drugs must be consid-
test solutions and conditions that existed in a study, it is
ered in evaluating such conflicting results, and absolute
certainly inappropriate to misinterpret a stability report
statements are often difficult or impossible to make. Dif-
like this as being an authorization to use the product clin-
ferences in concentrations, buffering systems, preserva-
ically. In such cases, the researchers may have used the
tives, vehicles, temperatures, and order of mixing all may
clinically inappropriate diluent to evaluate the drug’s
play a role. By reviewing a variety of reports, the user of
stability for extrapolation to a more suitable vehicle that
ASHP® Injectable Drug Information™ is better able to
is similar, or they may not have recognized that the dilu-
exercise professional judgment with regard to compati-
ent is clinically unsuitable. In either event, it is incumbent
bility and stability.
on the practitioner in the clinical setting to use profes- And, finally, contemporary practitioners have come
sional judgment to apply the information in an appropri- to expect that the analytical methods used in reports
ate manner and recognize what is not acceptable clini- on the chemical stability of drugs will be validated, sta-
cally. bility-indicating methods. However, many early studies
Further, it should be noted that many of the citations used methods that were not demonstrated to be stabil-
designated incompatible are not absolute. While a par- ity indicating.
ticular admixture may incur more than 10% decompo- Biological drugs (therapeutic proteins [e.g., enzymes,
sition within 24 hours, the combination may be useful monoclonal antibodies, immune globulins]) are partic-
for a shorter time period. The concept of “utility time” or ularly sensitive to environmental factors and undergo
the time to 10% decomposition may be useful in these more complex and numerous degradation pathways than
cases. Unfortunately, such information is often not avail- classical drugs.3207 3208 3212 In addition to physicochemical
able. Included in the Remarks columns of the tables are instability issues similar to those observed with classical
the amount of decomposition, the time period involved, drugs (e.g., precipitation, decomposition), such proteins
and the temperature at which the study was conducted are subject to other stability issues (e.g., protein confor-
when this information is available. mation, biologic activity) that must be considered.3207
Users of ASHP® Injectable Drug Information™ should
3208 3209 3212
Therefore, a single analytic method that only
always keep in mind that the information contained in assesses protein concentration is insufficient to deter-
this reference text must be used as a tool and a guide to mine stability of biological products.3209 3210 Interpreta-
the research that has been conducted and published. It tion of the results of compatibility and stability studies
is not a replacement for thoughtfully considered profes- of such proteins poses a challenge because both ana-
sional judgment. It falls to the practitioner to interpret lytic methods and meaningful acceptance criteria should
the information in light of the clinical situation, includ- be specific to the biologic; official compendial stan-
ing the patient’s needs and status. What is certain is that dards (e.g., The United States Pharmacopeia monographs
relying solely on the C or I designation without the appli- and analytic methods) should be consulted when avail-
cation of professional judgment is inappropriate. able.3206 3209 3212 Although many experts agree that mul-
tiple complementary methods should be used to assess
Limitations of the Literature the physical and chemical stability as well as assessment
of biologic activity, no clear guideline or recommenda-
In addition to conflicting information, many of the pub-
tion for in-use stability studies for therapeutic proteins
lished articles have provided only partial evaluations, not
is available.3208 3210 3211 3212
looking at all aspects of a drug’s stability and compati-
bility. This is not surprising considering the complexity, Literature Search for Updating ASHP®
difficulty, and costs of conducting such research. There
are, in fact, articles that do provide evaluations of both
Injectable Drug Information™
physical stability/compatibility and chemical stability. To gather the bulk of the published compatibility and
But some are devoted only to physical issues, while oth- stability information for updating ASHP® Injectable Drug
ers examine only chemical stability. Although a finding Information™, a literature search is performed using the
of precipitation, haze, or other physical effects may con- International Pharmaceutical Abstracts™ (IPA™) data-
stitute an incompatibility (unless transient), the lack of base and PubMed. By using key terms (e.g., stability), a
such changes does not rule out chemical deterioration. listing of candidate articles for inclusion in ASHP® Inject-
In some cases, drugs initially designated as compatible able Drug Information™ is generated. From this list, rel-
because of a lack of visual change were later shown to evant articles are critically evaluated and prioritized for
undergo chemical decomposition. Similarly, the deter- inclusion. As a supplement to this automated literature
mination of chemical stability does not rule out the pres- searching, a manual search of the references of the arti-
ence of unacceptable levels of particulates and/or tur- cles is also conducted, and any articles not included pre-
bidity in the combination. In a classic case, the drugs viously are similarly evaluated for inclusion. In addition,
leucovorin calcium and fluorouracil were determined pharmaceutical manufacturers may be contacted for
to be chemically stable for extended periods by stabil- additional in-house (unpublished) data.
ity-indicating HPLC assays in several studies, but years
later, repeated episodes of filter clogging led to the dis-
covery of unacceptable quantities of particulates in com-
binations of these drugs. The reader must always bear in
mind these possibilities when only partial information is
available.
RR Roerig TE Teva
RS Roussel TEC Teclapharm
RU Rugby TEL Teligent
SA Sankyo TES Tesaro
SAA Sanofi Aventis TET Tetraphase
SAG Sageant TL Tillotts
TMC The Medicines Company
SAN Sanofi
TO Torigian
SB Sintetica Bioren
TR Travenol
SC Schering
UCB UCB
SCI Scios UP Upjohn
SCN Schein USB US Bioscience
SCS SCS Pharmaceuticals USP United States Pharmacopeiab
SE Searle USV USV Pharmaceuticals
SEQ Sequus UT United Therapeutics
SER Servier VHA VHA Plus
SGS SangStat VI Vitarine
SGT Sagent VIC Vicuron Pharmaceuticals
SHI Shionogi VT Vitrum
SIA Siam Pharmaceutical WAS Wasserman
WAT Watson
SIC Sicor
WAY Wyeth-Ayerst
SIG Sigma Tau
WB Winthrop-Breon
SKB SmithKline Beecham
WC Warner-Chilcott
SKF Smith Kline & French
WED Weddel
SM Smith WEL Wellcome
SMX SteriMax WI Winthrop
SN Smith + Nephew WG WG Critical Care
SO SoloPak WL Warner Lambert
SP Spectrum Pharmaceuticals WOC Wockhardt
SQ Squibb WW Westward
SRB Serb WY Wyeth
SS Sanofi-Synthelabo XGN X-Gen
ST Sterilab XU Xudong Pharmaceutical Co.
YAM Yamanouchi
STP Sterop
ZEN Zeneca
STR Sterling
ZLB ZLB Biopharma
STS Steris
STU Stuart ZNS Zeneus Pharma
SUN Sun ZY ZyGenerics
SV Savage ZYD Zydus
SW Sanofi Winthrop
SX Sabex b
While reference to a compendium does not indicate the specific manufacturer of
SY Syntex a product, it does help to indicate the formulation that was used in the test.
SYN Synergen
SYO Synthelabo REFERENCES
SZ Sandoz For a list of references cited in the text of this monograph,
TAK Takeda search the monograph titled References.
TAL Talon Therapeutics
TAP TAP Holdings
TAR Targanta Therapeutics
TAY Taylor