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22960 Federal Register / Vol. 73, No.

82 / Monday, April 28, 2008 / Notices

2008, and should submit a brief DEPARTMENT OF HEALTH AND drug application (NDA). The only
statement of the general nature of the HUMAN SERVICES clinical data required in an ANDA are
evidence or arguments they wish to data to show that the drug that is the
present, the names and addresses of Food and Drug Administration subject of the ANDA is bioequivalent to
proposed participants, and an [Docket No. FDA–2008–N–0238] the listed drug.
indication of the approximate time The 1984 amendments include what
requested to make their presentation. Determination That TAPAZOLE Tablets is now section 505(j)(7) of the Federal
Time allotted for each presentation may and 18 Other Drug Products Were Not Food, Drug, and Cosmetic Act (the act)
be limited. If the number of registrants Withdrawn From Sale for Reasons of (21 U.S.C. 355(j)(7)), which requires
requesting to speak is greater than can Safety or Effectiveness FDA to publish a list of all approved
be reasonably accommodated during the drugs. FDA publishes this list as part of
AGENCY: Food and Drug Administration, the ‘‘Approved Drug Products With
scheduled open public hearing session, HHS. Therapeutic Equivalence Evaluations,’’
FDA may conduct a lottery to determine ACTION: Notice. which is generally known as the
the speakers for the scheduled open
‘‘Orange Book.’’ Under FDA regulations,
public hearing session. The contact SUMMARY: The Food and Drug
drugs are withdrawn from the list if the
person will notify interested persons Administration (FDA) has determined
agency withdraws or suspends approval
regarding their request to speak by May that the 19 drug products listed in this
of the drug’s NDA or ANDA for reasons
9, 2008. document were not withdrawn from
of safety or effectiveness, or if FDA
sale for reasons of safety or
Persons attending FDA’s advisory determines that the listed drug was
effectiveness. This determination means
committee meetings are advised that the withdrawn from sale for reasons of
that FDA will not begin procedures to
agency is not responsible for providing safety or effectiveness (21 CFR 314.162).
withdraw approval of abbreviated new
access to electrical outlets. Under § 314.161(a) (21 CFR
drug applications (ANDAs) that refer to
FDA welcomes the attendance of the 314.161(a)), the agency must determine
the drug products, and it will allow
public at its advisory committee whether a listed drug was withdrawn
FDA to continue to approve ANDAs that
from sale for reasons of safety or
meetings and will make every effort to refer to the products as long as they
effectiveness: (1) Before an ANDA that
accommodate persons with physical meet relevant legal and regulatory
refers to that listed drug may be
disabilities or special needs. If you requirements.
approved or (2) whenever a listed drug
require special accommodations due to FOR FURTHER INFORMATION CONTACT: is voluntarily withdrawn from sale, and
a disability, please contact Lee L. Olivia A. Pritzlaff, Center for Drug ANDAs that refer to the listed drug have
Zwanziger at least 7 days in advance of Evaluation and Research (HFD–7), Food been approved. Section 314.161(d)
the meeting. and Drug Administration, 10903 New provides that if FDA determines that a
FDA is committed to the orderly Hampshire Ave., Bldg. 51, rm. 6308, listed drug was removed from sale for
conduct of its advisory committee Silver Spring, MD 20993–0002, 301– safety or effectiveness reasons, the
meetings. Please visit our Web site at 796–3601. agency will initiate proceedings that SUPPLEMENTARY INFORMATION: In 1984, could result in the withdrawal of
default.htm for procedures on public Congress enacted the Drug Price approval of the ANDAs that refer to the
conduct during advisory committee Competition and Patent Term listed drug.
meetings. Restoration Act of 1984 (Public Law 98– FDA has become aware that the drug
417) (the 1984 amendments), which products listed in the table in this
Notice of this meeting is given under authorized the approval of duplicate document are no longer being marketed.
the Federal Advisory Committee Act (5 versions of drug products approved (As requested by the applicants, FDA
U.S.C. app. 2). under an ANDA procedure. ANDA withdrew approval of NDA 7–517 for
Dated: April 18, 2008. sponsors must, with certain exceptions, TAPAZOLE Tablets in the Federal
Randall W. Lutter, show that the drug for which they are Register of November 7, 2007 (72 FR
Deputy Commissioner for Policy. seeking approval contains the same 62858), NDA 18–754 for ORUDIS
active ingredient in the same strength Capsules in the Federal Register of June
[FR Doc. E8–9177 Filed 4–25–08; 8:45 am]
and dosage form as the ‘‘listed drug,’’ 16, 2006 (71 FR 34940), NDA 18–062 for
which is a version of the drug that was PROVENTIL Syrup in the Federal
previously approved. Sponsors of Register of March 4, 2005 (70 FR
ANDAs do not have to repeat the 10651), and NDA 8–604 for
extensive clinical testing otherwise PHENERGAN VC Syrup in the Federal
necessary to gain approval of a new Register of May 5, 2004 (69 FR 25124).

NDA No. Drug Applicant

7–517 TAPAZOLE (methimazole) Tablets, 5 milligrams (mg) and King Pharmaceuticals, Inc., 501 Fifth St., Bristol, TN
10 mg 37620

7–935 PHENERGAN (promethazine hydrochloride (HCl)) Tab- Wyeth Pharmaceuticals,Inc., P.O. Box 8299, Philadel-
lets, 25 mg phia, PA 19101–8299

8–306 PHENERGAN with Codeine (codeine phosphate and ANI Pharmaceuticals, Inc., 7131 Ambassador Rd.,
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promethazine HCl) Syrup, 6.25 mg/5 milliliters (mL), 10 Woodlawn, MD 21244

mg/5 mL

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Federal Register / Vol. 73, No. 82 / Monday, April 28, 2008 / Notices 22961

NDA No. Drug Applicant

8–306 PHENERGAN VC with Codeine (codeine phosphate; Do.

phenylephrine HCl; promethazine HCl) Syrup, 5 mg/5
mL; 6.25 mg/5 mL; 10 mg/5 mL

8–381 PHENERGAN FORTIS (promethazine HCl) Syrup, 25 Do.

mg/5 mL

8–381 PHENERGAN Plain (promethazine HCl) Syrup, 6.25 mg/ Do.

5 mL

8–604 PHENERGAN VC (phenylephrine HCl; promethazine Do.

HCl) Syrup, 5 mg/5 mL; 6.25 mg/5 mL

9–000 CAFERGOT (caffeine; ergotamine tartrate) Suppository, Novartis Pharmaceuticals Corp., One Health Plaza, East
100 mg/2 mg Hanover, NJ 07936–1080

9–509 ARAMINE (metaraminol bitartrate) Injection, equivalent to Merck & Co., Inc., 770 Sumneytown Pike, BLA–20, P.O.
(EQ) 10 mg base/mL Box 4, West Point, PA 19486

11–265 PHENERGAN with Dextromethorphan (dextromethorphan ANI

hydrobromide; promethazine HCl) Syrup, 6.25 mg/5
mL; 15 mg/5 mL

11–459 VISTARIL (hydroxyzine pamoate EQ hydroxyzine HCl) Pfizer, Inc., 235 East 42nd St., New York, NY 10017
Capsules, 100 mg

11–689 PHENERGAN (promethazine HCl) Suppository, 50 mg Wyeth

12–125 CARBOCAINE (mepivacaine HCl) Injection, 3 % (30 mg/ Eastman Kodak Co., Dental Products, 343 State St.,
mL/1.8 mL cartridge) Rochester, NY 14612–1122

18–062 PROVENTIL (albuterol sulfate) Syrup, EQ 2 mg base/ Schering Corp., 2000 Galloping Hill Rd., Kenilworth, NJ
5mL 07033

18–152 ESKALITH CR (lithium carbonate) Extended Release GlaxoSmithKline, One Franklin Plaza, P.O. Box 7929,
Tablets, 450 mg Philadelphia, PA 19101–7929

18–200 MIDAMOR (amiloride HCl) Tablets, 5 mg Merck

18–201 MODURETIC 5–50 (amiloride HCl; hydrochlorothiazide) Merck

Tablets, 5 mg/50 mg

18–754 ORUDIS (ketoprofen) Capsules, 25 mg, 50 mg, and 75 Wyeth


20–460 CYTOVENE (ganciclovir) Capsules, 250 mg and 500 mg Roche Laboratories, Inc., 340 Kingsland St., Nutley, NJ

FDA has reviewed its records and, legal and regulatory requirements. If DEPARTMENT OF HEALTH AND
under § 314.161, has determined that FDA determines that labeling for these HUMAN SERVICES
the drug products listed in this drug products should be revised to meet
document were not withdrawn from current standards, the agency will Health Resources and Services
sale for reasons of safety or advise ANDA applicants to submit such Administration
effectiveness. Accordingly, the agency labeling.
will continue to list the drug products Statement of Organization, Functions
Dated: April 18, 2008. and Delegations of Authority
listed in this document in the
‘‘Discontinued Drug Product List’’ Jeffrey Shuren,
This notice amends Part R of the
section of the Orange Book. The Associate Commissioner for Policy and
Statement of Organization, Functions
‘‘Discontinued Drug Product List’’ Planning.
and Delegations of Authority of the
identifies, among other items, drug [FR Doc. E8–9161 Filed 4–25–08; 8:45 am]
Department of Health and Human
products that have been discontinued BILLING CODE 4160–01–S Services (HHS), Health Resources and
from marketing for reasons other than Services Administration (HRSA) (60 FR
safety or effectiveness. 56605, as amended November 6, 1995;
Approved ANDAs that refer to the as last amended at 73 FR 12742–12744
NDAs listed in this document are dated March 10, 2008).
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unaffected by the discontinued This notice reflects organizational

marketing of the products subject to changes in the Health Resources and
those NDAs. Additional ANDAs for the Services Administration. Specifically,
products may also be approved by the this notice moves the Office of
agency if they comply with relevant Management (RS) under the Immediate

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