Website Update 01-10-2021 to 31-10-2021

S. Date of
Drug Name Composition Indication
No Approval
It is indicated to control the
progression of myopia in
Each ml Contains: children of 5 years and
Atropine above
Atropine Sulfate Sulfate……………
Ophthalmic ……………………
Solution USP ….0.1 mg "WARNING: To be sold by 12-01-
1 0.01% w/v Polyhexamethylen 2021
retail on the prescription
e biguanide of Ophthalmologist only”
(Additional Hydrochloride……
Strength) ……0.05mg (As With the Condition to
Preservative) conduct phase IV Clinical
trial to assess long term
safety of the product.
(i) Colistimethate For the treatment of some
Sodium for serious infections caused by
Injection IP 3 MIU Gram-negative bacteria,
Each Vial contains including those of the lower
Colistimethate respiratory tract and urinary
Colistimethate
Sodium………….3 tract, when more commonly
Sodium For
000000 IU used systemic antibacterial
Injection IP 3
agents may be
MIU/ 4.5 MIU (ii) Colistimethate 15-01-
2 contraindicated or may be
sodium for 2021
ineffective because of
Injection IP 4.5 bacterial resistance.
(Additional MIU
Strength)
Each Vial
Contains: "WARNING: To be sold by
Colistimethate retail on the prescription
Sodium………..45 of a Medical Specialist
00000 IU only”

Each film-coated For the treatment of patients

tablets contains: of Chronic Kidney Disease
Dapagliflozin
(CKD) up to Stage III (eGFR
Tablets 10 mg Dapagliflozin of greater than or equal to 03-02-
3 propanediol 30ml/min/1.73m2)
monohydrate 2021

Additional equivalent to “WARNING: To be sold by

Dapagliflozin…….. retail on the prescription
Indication
10 mg of Nephrologist only”
 Brivaracetam
Oral Solution
As adjunctive therapy in the
Solution Each ml contains: treatment of partial onset
10mg/ml 03-02-
4 Brivaracetam seizures in patients 16
2021
……10mg years of age and older with
epilepsy
Additional
Dosage Foam

Drospirenone
Tablets 4 mg Drospirenone is a Progestin
Each for uncoated
intended for its use by
Tablets 15-02-
5 females of reproductive
Drospirenone…… 2021
potentials to prevent
Additional 4 mg
pregnancy
Strength

Apomorphine
Hydrochloride
Apomorphine solution for For the treatment of disabling
Hydrochloride 5 infusion in 20ml motor fluctuations (“on-off”
mg/ml solution vial Each ml phenomena) in patients with
for infusion in contains: Parkinson’s disease which
20ml vial Apomorphine persist individually titrated
Hydrochloride…… treatment with Levodopa
Apomorphine … 5mg (with a peripheral
Hydrochloride decarboxylase inhibitor) 16-02-
6
10 mg/ml Apomorphine and/or other dopamine 2021
solution for Hydrochloride agonists.
injection in 3ml solution for
cartridge injection in 3ml
cartridge Each ml “WARNING: To be sold by
Additional contains: retail on the prescription of
pack size & Apomorphine Neurologists only”
strength Hydrochloride……
10 mg
Thyroxine
Sodium Tablets Each uncoated
88 mcg / tablet contains:
200mcg For the treatment of 22-02-
7 Thyroxine hypothyroidism 2021
Sodium………...88
mcg / 200 mcg
Additional
Strength
 Brivaracetam
injection
50mg/5ml As adjunctive therapy in the
Each ml
(10mg/ml) treatment of partial-onset
Contains: 24-02-
8 seizures in patients 16 years
Brivaracetam…… 2021
Additional of age and older with
dosage form & ….10mg epilepsy
New route of
administration
Maintenance treatment of
Aripiprazole schizophrenia in adult
powder and patients stabilized with oral
solvent for aripiprazole
prolong-release Each vial contains:
suspension for Aripiprazole………
injection 300mg / 400mg 01-03-
9
300mg/vial and (Supplied along 2021
400 mg/vial with “WARNING: To be sold by
solvent/diluent)
retail on the prescription
of an Psychiatrist only”
(Modified
Dosage Form)
Rebamipide Each ml contains:
Ophthalmic Rebamipide…..2.0
Suspension 2% %w/v Indicated for the treatment
w/v with Stabilized 01-03-
10 of dry eye signs and
Stabilized Oxychloro 2021
symptoms
Oxychloro Complex…..0.01%
complex (as w/v (As
preservative) Preservative)
Each uncoated
Pancreatin tablet Contains:
Tablets USP Pancreatin
200 mg ...200mg Indicated in combination with
Equivalent to a proton pump inhibitor in
Lipase adults for the treatment of
01-03-
11 ……..10,440 USP exocrine pancreatic
(Additional 2021
units insufficiency due to chronic
Strength/New Amylase………… pancreatitis or
dosage ….39,150 USP pancreatectomy
form/New units
Indication) Protease………….
..39150 USP units
 In combination with
pembrolizumab and platinum
chemotherapy, for the initial
treatment of patients with
Pemetrexed for Each vial contains: metastatic non-squamous
injection Pemetrexed NSCLC, with no EGFR or
100mg/500mg Disodium ALK genomic tumor 08-03-
12
equivalent to aberrations 2021
(Additional Pemetrexed
Indication) …100mg/500mg
"WARNING: To be sold by
retail on the prescription of
oncologist only”
Indicated in adults for the
short-term symptomatic
treatment of acute moderate
Ibuprofen pain, and for the short-term
solution for symptomatic treatment of
infusion Each ml contains:
13 Ibuprofen fever, when administration by 08-03-
400mg/100ml intravenous route is clinically 2021
……………4mg
justified when other routes of
(New Dosage administration are not
Form) possible

Cholecalciferol
oral drops
800IU/ml Each ml contains: For the treatment of vitamin 08-03-
14 Cholecalciferol D3 deficiency 2021
(Additional ……800IU
Strength/New
dosage Form)
Osimertinib as monotherapy
is indicated for: The adjuvant
treatment after complete
tumour resection in patients
with nonsmall cell lung
Osimertinib cancer (NSCLC) whose
Tablets 40mg Each film-coated
tumours have epidermal
and 80mg tablets contains: growth factor receptor 09-03-
15 Osimertinib (as (EGFR) exon 19 deletions or 2021
mesylate)…...40 exon 21 (L858R) substitution
(Additional mg/80mg mutations
Indication)

“WARNING: To be sold by
retail on the prescription of
oncologist only”
 In combination with other
antiretroviral agents for the
treatment of Human
Immunodeficiency Virus
type1 (HIV-l) infection in
Each Tablet
Dolutegravir adults (treatment-naive or-
Dispersible contains: experienced) and in pediatric
Tablets 10mg Dolutegravir patients (treatment-naive or - 23-03-
16 sodium experienced but integrase 2021
equivalent to strand transfer inhibitor
(Additional Dolutegravir [INSTI]-naive) aged at least 4
Dosage Form) weeks and weighing at least
10mg
3 kg
"WARNING: To be sold by
retail on the prescription of
a Specialist only”
For the treatment of Erectile
Dysfunction in men
Sildenafil Citrate Each Spray
Oral Spray (0.2ml) delivers
12.5% w/v Sildenafil citrate 26-03-
17
equivalent to 2021
“WARNING: To be sold by
(Additional Sildenafil…….25
Dosage Form) retail on the prescription of
mg an Urologist, Psychiatrist
and Endocrinologist only”
Dexamethasone is indicated
for treatment of variety of
disorders in which systemic
glucocorticoids are indicated
including:
• Neurology: Cerebral
Dexamethasone oedema (only with
Tablets 6 mg Each film coated symptoms of intracranial
tablet contains : pressure evidenced by 06-04-
18
Dexamethasone computerised tomography) 2021
……6 mg caused by a primary or
(Additional
Strength) metastatic brain tumour,
craniotomy or head injury.
• Dermatology: Initial
treatment of extensive,
severe, acute, skin diseases
responding to
glucocorticoids, e.g.
 erythroderma, pemphigus
vulgaris.
• Autoimmune
disorders/rheumatology:
Initial treatment of
autoimmune disorders like
systemic lupus
erythematodes, in acute
gouty arthritis ,acute arthritis
carditis, ankylosing
spondylitis ,psoriatic arthritis
, Severe progressive course
of active rheumatoid arthritis
Severe systemic course of
juvenile idiopathic arthritis
(Still's disease).
• Haematological disorder:
Idiopathic thrombocytopenic
purpura in adults.
• Oncologists only- for
steroid responsive
neoplastic disease like
leukemias and lymphomas
in adults only.
Betahistine
Hydrochloride
Orally Each Uncoated
Disintegrating
Orally Indicated for the
tablet 8
Disintegrating symptomatic treatment of
mg/16mg/24 mg
Tablet Contains: 06-04-
19 vertigo caused due to
Betahistine 2021
conditions including
Hydrochloride Menier’s syndrome.
(New Dosage mg/16mg/24mg
Form) Excipients q.s.

Pegaspargase
powder for Indicated as a component of
Each vial contains:
solution for anti-neoplastic combination
Pegaspargase
therapy in acute
injection/ ……3750 U (After 09-04-
20 infusion lymphoblastic leukaemia
reconstitution each 2201
(ALL) in paediatric patients
ml contains 750U
from birth to 18 years, and
of Pegaspargase)
adult patients
 (New Dosage
Form &
Indication)

Drospirenone Drospirenone is a Progestin

Tablets 4mg Each Film Coated
intended for its use by
Tablet Contains: 22-04-
21 females of reproductive
Drospirenone 2021
potentials to prevent
(New Dosage ……………4mg pregnancy
Form)
Baricitinib, in combination
with Remdesivir, for
treatment of suspected or
laboratory confirmed
coronavirus disease 2019
(COVID-19) in hospitalized
Baricitinib
adults requiring supplemental
Tablets 1mg, Each Film Coated oxygen, invasive mechanical
2mg, & 4 mg
Tablet Contains: ventilation, or extracorporeal
22 Baricitinib….1mg/ membrane oxygenation 01-05-
(ECMO) 2021
(Additional 2mg/4 mg
Strength &
Additional
Indication)
“WARNING: To be sold by
retail on the prescription of
specialist for use in
Hospital/ Institutional set
up only”
For treatment of suspected or
laboratory confirmed corona
virus disease 2019 (COVID-
19) in adults and children
Remdesivir hospitalized with moderate to
Injection Each ml severe disease
100mg/20 ml 06-05-
23 Contains- 2201
(without Remdesivir...5mg
“WARNING: To be sold by
Cyclodextrin) retail on the prescription of
specialist for use in
Hospital/ Institutional set
up only”
 For the treatment of patients
Favipiravir Oral with mild to moderate Covid-
suspension 19 disease
Each ml contains: 19-05-
24 100mg/ml Favipiravir……...... 2021
100mg “Warning To be sold on
(New Dosage
Form) prescription of medical
specialist”
 For the treatment of
oropharyngeal candidiasis,
including oropharyngeal
candidiasis refractory to
Itraconazole and/or
fluconazole for prophylaxis
of invasive Aspergillus and
Candida infections in
patients, 13 years of age and
older, who are at high risk of
developing these infections

Posaconazole Each Delayed- due to being severely

Delayed- Release Tablets immunocompromised, such
Release Tablets contains: 28-05-
25 as hematopoietic stem cell 2021
(Additional Posaconazole…… transplant (HSCT) recipients
Indication) . 100mg
with graft-versus-host
disease (GVHD) or those
with hematologic
malignancies with prolonged
neutropenia from
chemotherapy.
 Zygomycosis
(Mucormycosis) in patients
with diseases refractory to
other therapy ,or or patients
who are intolerant to other
therapy
 “Warning To be sold on
prescription of medical
specialist”

For prophylaxis of invasive

Aspergillus and Candida
infections in patients who are
at high risk of developing
these infections due to being
severely
immunocompromised, such
as hematopoietic stem cell
Posaconazole transplant (HSCT) recipients
Gastro- Each Gastro- with graft-versus-host
Resistant Resistant Tablet disease (GVHD) or those
Tablets 300 mg Contains: with hematologic 07-06-
26 malignancies with prolonged 2021
Posaconazole…..3 neutropenia from
00 mg chemotherapy.
(Additional Posaconazole Gastro
Strength) Resistant Tablets are
indicated in patients 13
years of age and older.

"WARNING: To be sold by
retail on the prescription
of a Medical Specialist
only”
Ulinastatin for
injection 200000  For the treatment of
IU (Liquid) Each vial Contains: severe sepsis.
Ulinastatin  For the treatment of 24-06-
27
………….200000 2021
mild and severe acute
(Additional IU pancreatitis.
Strength)
Imatinib Oral 1. Treatment of adult and
Solution 80 pediatric patients with newly
mg/ml Each ml contains: diagnosed Philadelphia
24-06-
28 Imatinib (As chromosome positive acute
2021
mesilate).......80mg lymphoblastic leukemia (Ph+
(New Dosage ALL) integrated with
Foam) chemotherapy.
 2. Treatment of adult patients
with relapsed or refractory
Ph+ ALL as monotherapy.
3. Adjuvant treatment of adult
patients following resection of
gastro-intestinal stromal
tumors (GIST), and 4.
Treatment of CML in blast
crisis, accelerated phase or in
chronic phase after failure of
interferon alpha therapy.

“WARNING: To be sold by
retail on the prescription of
oncologist only”
Indicated in the management
Clozapine of schizophrenic patients
Tablet 12.5 mg Each uncoated
29-06-
29 tablet contains:
2021
Clozapine 12.5 mg "WARNING: To be sold by
(Additional retail on the prescription of
Strength) Neurologist only”
For the treatment of
hepatocellular carcinoma,
advanced renal cell
Each film coated carcinoma and locally
Sorafenib
Tablets 400mg tablets contains : advance or metastatic
30 Sorafenib differentiated thyroid 30-06-
Tosylate eq. to carcinoma refractory to 2021
(Additional
Strength) Sorafenib…400 mg radioactive iodine
"WARNING: To be sold by
retail on the prescription of
Oncologist only”
For the treatment of patients
Favipiravir Each sachet with mild to moderate Covid-
Powder for Oral contains: 19 disease
suspension 1.5g of Favipiravir
800mg powder contains: 06-07-
31
2021
Favipiravir...........8
00mg “WARNING: To be sold on
(Additional the prescription of medical
Excipients.....q.s
Dosage Form) specialist”
 Heparin Sodium
Topical Solution Each ml contains
For Prevention of infusion
1000 IU/ml :
associated phlebitis
Heparin Sodium
……1000 IU/ml 09-07-
32 Absolute 2021
Alcohol……….10 "WARNING: To be sold by
.00% v/v retail on the prescription
Topical Solution of Specialists only”
(Additional
base…….q.s.
Indication)
1. Indicated as a
monotherapy for the
maintenance treatment of
locally advanced or
metastatic Non-Small Cell
Lung Cancer (NSCLC)
other than predominantly
squamous cell histology in
patients whose disease has
not progressed immediately
following platinum-based
chemotherapy. First line
treatment Should be a
platinum doublet with
gemcitabine, paclitaxel or
Pemetrexed for docetaxel. 2. In combination
injection Each vial contains:
Pemetrexed with cisplatin is indicated for
1000mg the first line treatment of
(Lyophilized) Disodium
33 heptahydrate IP patients with locally 16-07-
equivalent to advanced or metastatic 2021
Pemetrexed non-small cell lung cancer
(Additional ………1000mg other than predominantly
Strength) squamous cell histology.
3. As monotherapy for the
second-line treatment of
patients with locally
advanced or metastatic
non-small cell lung cancer
other than predominantly
squamous cell histology.
4. As monotherapy for the
maintenance treatment of
locally advanced or
metastatic non-small cell
lung cancer other than
predominantly squamous
cell histology in patients
whose disease has to
 progressed immediately
following platinum based
chemotherapy.
"WARNING: To be sold by
retail on the prescription of
oncologist only”

Acetyl Salicylic
Acid Each Effervescent
Effervescent tablet contains: 16-07-
34 Tablets 500 mg Acetyl Analgesic & Anti pyretic
Salicylic 2021
Acid … 500 mg
(Additional
Dosage Foam)
Pentosan
polysulfate
sodium sterile For intravesical treatment of
solution for the bladder pain
intravesical Each ml contains: syndrome/interstitial cystitis
35 instillation 10 Pentosan 16-07-
mg/ml (30ml) Polysulfate Sodium 2021
…………..10mg "WARNING: To be sold by
(Additional retail on the prescription of
Dosage form & a Specialist only”
Route of
administration)
Amikacin Injection
IP 750 mg Each
3ml Contains:
Amikacin Sulphate
IP Equivalent to Amikacin Injection is
Amikacin indicated in the treatment of
…………750 mg serious infections due to
Amikacin Water for Injections Amikacin sensitive organisms
Injection IP………… q.s
750mg/3ml & Methylparaben
1000 mg/4ml IP……0.04w/v 23-07-
36 Propylparaben 2021
(Additional IP……0.01w/v (As
pack size preservatives)
/Additional (Suitable buffering
Strength) agent and "WARNING: To be sold by
antioxidant added) retail on the prescription of
Amikacin Injection a Specialist only”
IP 1000 mg Each
4ml Contains:
Amikacin Sulphate
IP Equivalent to
Amikacin …..1000
 mg Water for
Injections
IP………… q.s
Methylparaben
IP……0.04w/v
Propylparaben
IP……0.01w/v (As
preservatives)
(Suitable buffering
agent and
antioxidant added)
Riboflavin
Sodium
Phosphate IP
eq. to Riboflavin Each ml contains:
0.1 % w/v with Riboflavin Sodium
Hypromellose Phosphate IP Eq. To treat keratoconus and
27-07-
37 Ophthalmic to Riboflavin corneal ectasia following
2021
Solution in PFS ……….0.1% w/v refractive surgery
(Pack Size is Hypromellose
3.0ml) I.P…….1.1%w/v

(Additional
Pack Size)
For the treatment of
dermatomycosis caused by
Amorolfine Each ml contains: dermatophytes, cutaneous
Lotion 0.25% Amorolfine candidiasis and pityriasis
w/v Hydrochloride versicolor 29-07-
38
Equivalent to 2021
(Additional Amorolfine…….0.2
Dosage Form) 5% w/v "WARNING: To be sold by
retail on the prescription of
an Dermatologist only”
For the treatment of signs and
Silodosin Tablet symptoms of benign prostatic
8 mg hyperplasia (BPH) in adults
Each film coated only
30-07-
39 tablets contains :
2021
Silodosin…8 mg
(Additional "WARNING: To be sold by
Dosage Form) retail on the prescription of
a Urologist only”
 For treatment of suspected
or laboratory confirmed
corona virus disease 2019
(COVID-19) in adults and
Remdesivir
Injection children hospitalized with
100mg/20ml Each ml contains: moderate to severe disease,
(5mg/ml) in light of Covid 19 outbreak,
Remdesivir…5mg for restricted emergency use 05-08-
40
Hydrocypropyl in the country. 2021
Betadex (As
(with excipient)…300mg
Hydroxypropyl
“Warning : To be Sold by
Betadex as
retail on the prescription
Excipent)
of specialist for use in
Hospital/Institutional set
up only”
For the treatment of Chronic
Spontaneous Urticaria

Bilastine Tablets
40mg The firm should conduct
Each film-coated an active PMS study.
tablet contains : Accordingly, the firm 06-08-
41
Bilastine should submit active PMS 2021
……40mg. protocol for review by the
(Additional
committee
Strength)
"WARNING: To be sold by
retail on the prescription
of Dermatologist only”
In the treatment of adult men
with metastatic castration-
resistant prostate cancer who
Enzalutamide are asymptomatic or mildly
Hard Gelatin Each Hard Gelatin symptomatic after failure of
Capsules 80mg Capsule contains : androgen deprivation therapy
42 Enzalutamide in whom chemotherapy is not 06-08-
2021
…………………… yet clinically indicated.
(Additional …..80mg
Indication)
"WARNING: To be sold by
retail on the prescription of
Oncologist only”
 Indicated for the adjuvant
treatment in combination with
Each pack tamoxifen or an aromatase
contains: One vial inhibitor, of hormone
of Triptorelinreceptor-positive early stage
Triptorelin pamoate forbreast cancer in women at
powder for injection Each high risk of recurrence who
Injection 3.75 single dose vial are confirmed as 06-08-
43 mg/vial contains: (Sterile premenopausal after 2021
Lyophilized) completion of
Triptorelin pamoate chemotherapy”.
(Additional equivalent to
Indication) Triptorelin ….. 3.75
mg
Excipients…….q.s. “WARNING: To be sold by
retail on the prescription of
Oncologist only”
Lorlatinib is indicated for the
treatment of adult patients
with metastatic non-small cell
Lorlatinib tablets
25/100 mg Each film-coated lung cancer (NSCLC) whose
tablets contains: tumors are anaplastic 06-08-
44
Lorlatinib………… lymphoma kinase (ALK) 2021
……25mg/100mg positive
(Additional
Indication) “WARNING: To be sold by
retail on the prescription of
oncologist only”
“Palbociclib is indicated for
the treatment of hormone
receptor (HR)-positive,
human epidermal growth
Palbociclib Each Hard Gelatin factor 2 (HER2)- negative
Capsules and Capsule contains: advanced or metastatic
Palbociclib Palbociclib……… breast cancer in combination
Tablets ….75mg/100mg/12 with an aromatase inhibitor as
75/100/125 mg 5mg Each Film- initial endocrine-based
45 therapy and with Fulvestrant
Coated Tablets
contains: in patients who have received
Palbociclib……… prior therapy for Male
….75mg/100mg/12 patients"
(Additional 5mg
Indication)
“WARNING: To be sold by
retail on the prescription of
oncologist only”
 Itraconazole 130 mg Capsule
is indicated for the treatment
of the following fungal
infections in
immunocompromised and
non- immunocompromised
adult patients:
 Blastomycosis,
Pulmonary and Extra
pulmonary
Itraconazole  Histoplasmosis,
Capsule 130 mg Each Capsule including chronic cavitary
Contains: pulmonary disease and 09-08-
46 (Additional disseminated, non- 2021
Itraconazole………
Strength and ..130 mg meningeal
additional histoplasmosis.
Indication)  Aspergillosis, pulmonary
and extra-pulmonary, in
patients who are
intolerant of or who are
refractory to
amphotericin B therapy

"WARNING: To be sold by
retail on the prescription of
a Specialist only”
Indicated in adults for luteal
support as part of an Assisted
Each Vial Reproductive Technology
Progesterone (2.237ml)
Solution for Contains: (ART) treatment program in
Injection infertile women who are
Progesterone unable to use or tolerate 17-08-
47 (50mg/2.237ml) ………………….
vaginal preparations. 2021
50mg (22.35
mg/ml) Water for
(Additional Injections
Strength) IP…………q.s. "WARNING: To be sold by
retail on the prescription of
a Gynecologists only”
Estradiol 1.53 Each actuation
Hormone Replacement
mg/ actuation, delivers Estradiol
Therapy (HRT) for Estrogen
Transdermal Ph.
deficiency symptoms in Peri /
spray, solution Eur………………
48 postmenopausal women (in 17-08-
…1.53 mg
women at least 6 months 2021
(Additional (Equivalent to
since last menses or surgical
dosage form 1.58mg Estradiol
menopause, with or without a
and Additional hemihydrate)
uterus). The experience in
Indication) Ethanol 96% USP
 …………………0.0 treating women older than 65
9 ml ( Octisalate years is limited
USP and Ethanol
96% used as
excipients ) Firm should conduct active
Post Marketing
Surveillance study to
assess the safety and
efficacy. Firm should
submit the results of the
PMS study within one year
from date of approval.

“WARNING: To be sold by
retail on the prescription of
Gynecologists only”
For the treatment of
oropharyngeal candidiasis,
including oropharyngeal
candidiasis refractory to
itraconazole and/or
fluconazole. For prophylaxis
of invasive Aspergillus and
Candida infections in
patients, 13 years of age and
older, who are at high risk of
developing these infections
Posaconazole due to being severely
Gastro immunocompromised, such
Resistant Each Gastro as Hematopoietic Stem Cell
Tablets 300 mg Resistant Tablets Transplant (HSCT) recipients
17-08-
49 Contains: with Graft-Versus Host 2021
Posaconazole…… Disease (GVHD) or those
….300 mg with hematologic
(Additional malignancies with prolonged
Indication) neutropenia from
chemotherapy. Zygomycosis
(Mucormycosis). in patients
with disease refractory to
other therapy, or patients who
are intolerant of other therapy

"WARNING: To be sold by
retail on the prescription of
a Medical Specialist only”
 (i) Mesalazine
Prolonged Release
Granules 1gm
Each Sachet
Contains:
Mesalazine
………… 1gm
Mesalazine Excipients
Prolonged …………...q.s (as Chronic inflammatory bowel
Release film coated disease (Ulcerative Colitis
Granules 1gm &granules) and Crohn’s disease) 17-08-
50 2gm
(ii) Mesalazine 2021
Prolonged Release
(Additional
Granules 2gm
dosage form &
Each Sachet
strengths)
Contains:
Mesalazine
………… 2gm
Excipients
…………... q.s (as
film coated
granules)
Indicated to increase tear
production in patients with
keratoconjunctivitis sicca (dry
Cyclosporine
Ophthalmic Each ml contains: eye).
Solution 0.09% Cyclosporine
w/v IP………………0.0
23-08-
51 9 mg Aqueous Firm required to conduct
Buffered Phase IV clinical trial. 2021
(Additional
Accordingly firm should
dosage & Vehicle…………q.
s submit phase IV protocol
Additional
Indication) “WARNING: To be sold by
retail on the prescription of
Ophthalmologist only”
For continued treatment of
adult patients with acute
Azacitidine myeloid leukemia who
Tablets 300 mg Each film coated achieved first complete
remission (CR) or complete
tablet contains: 23-08-
52 (New Dosage Azacitidine remission with incomplete
IP 2021
form & …………300 mg blood count recovery (CRI)
Additional following intensive induction
Indication) chemotherapy and are not
able to complete intensive
curative therapy
 "WARNING: To be sold by
retail on the prescription of
Oncologist only”

Indicated for sterilization

during the perioperative
period of ophthalmic surgery

Each ml of “WARNING: To be sold by

Moxifloxacin Ophthalmic retail on the prescription
Ophthalmic Solution contains: of Ophthalmologists only”
Solution 0.5% Moxifloxacin 02-09-
53
w/v Hydrochloride 2021
equivalent to The firm should submit
(Additional Moxifloxacin
protocol for active PMS
Indication) base…………5 mg
Study

Minoxidil Topical
Solution 2% Each
ml contains:
Minoxifil IP 20mg
Alcohol (95%) IP For the treatment of
equivalent to androgenic alopecia in
Minoxidil females (female pattern hair
absolute alcohol
Topical Solution loss)
63% v/v 02-09-
54 2% and 5%
2021
(Additional Minoxidil Topical
Indication) Solution 5% Each "WARNING: To be sold by
ml contains: retail on the prescription
Minoxifil IP 50mg of a Dermatologist only”
Alcohol (95%) IP
equivalent to
absolute alcohol
40% v/v
 1. Malignant pleural
Each ml Contains: mesothelioma:
Pemetrexed
Disodium  In combination with
Heptahydrate Cisplatin is indicated for
Equivalent to the treatment of
Pemetrexed…5mg chemotherapy naive
Sodium Chloride patients with unresectable
………………9mg malignant pleural
Water for Injections mesothelioma.
……………….q. s.
2. Non-Small Cell Lung
Pemetrexed Cancer (NSCLC):
Disodium
Heptahydrate  In combination with
Equivalent to cisplatin is indicated for
Pemetrexed 6mg the first line treatment of
Pemetrexed
patients with locally
Solution for Sodium Chloride
advanced or metastatic
Infusion 5mg/ml, ……………… 9mg
Water for Non-Small Cell Lung
6mg/ml,
Injections...….…… Cancer (NSCLC) other
6.5mg/ml,
……q. s. than predominantly
7mg/ml,
squamous cell histology. 
7.5mg/ml, Pemetrexed As a monotherapy for the
8mg/ml, Disodium second-line treatment of
8.5mg/ml, Heptahydrate 03-09-
55 patients with locally
9mg/ml, Equivalent to 2021
advanced or metastatic
10mg/ml & Pemetrexed 6.5mg
Non-Small Cell Lung
11mg/ml (100ml Sodium Chloride
Cancer (NSCLC) other
ready to use ………………9mg
than predominantly
infusion bag Water for Injections squamous cell histology. 
……………….q. s. As a monotherapy for the
Pemetrexed maintenance treatment of
(Additional
Disodium locally advanced or
Dosage Form)
Heptahydrate metastatic Non-Small Cell
Equivalent to Lung Cancer (NSCLC)
Pemetrexed…..7m other than predominantly
g Sodium Chloride squamous cell histology in
……………….9mg patients whose disease
Water for Injections has not progressed
……………….q. s. immediately following
platinum-based
Pemetrexed chemotherapy.
Disodium
Heptahydrate  In combination with
Equivalent to pembrolizumab and
Pemetrexed 7.5mg platinum chemotherapy,
Sodium Chloride for the initial treatment of
…………………… patients with metastatic
…9mg Water for non-squamous Non-Small
Cell Lung Cancer
Injections (NSCLC), with no EGFR
..……………….q. s or ALK genomic tumor
aberrations.
Pemetrexed
Disodium
Heptahydrate
Equivalent to
Pemetrexed…..8m
g Sodium Chloride
…………………… "WARNING: To be sold
…9mg Water for by retail on the
Injections prescription of an
………………q. s. oncologist only”

Pemetrexed
Disodium
Heptahydrate
Equivalent to
Pemetrexed 8.5mg
Sodium Chloride
.......……………….
9mg Water for
Injections
………………q. s.
Pemetrexed
Disodium
Heptahydrate
Equivalent to
Pemetrexed…..9m
g Sodium Chloride
…………………….
9mg Water for
Injections
………………..q. s.
Pemetrexed
Disodium
Heptahydrate
Equivalent to
Pemetrexed 10mg
Sodium Chloride
….…………….9mg
Water for Injections
….…………….q. s.
Pemetrexed
Disodium
Heptahydrate
Equivalent to
Pemetrexed 11mg
Sodium Chloride
 ……………….9mg
Water for Injections
……………….q. s.

In treatment of adult patient

with moderately to severely
active Ulcerative Colitis (UC),
who have an inadequate
Each Film coated response and who are
Tofacitinib tablets contains: intolerant to TNF blockers
Tablets 5mg Tofacitinib citrate 13-09-
56
equivalent to 2021
(Additional Tofacitinib…… “WARNING: To be sold by
Indication) 5mg retail on the prescription of
Rheumatologist,
Gastroenterologist,
Hepatologist or “Specialist
in internal Medicine only”
Each Orally
Prucalopride Disintegrating
Orally Strips Contains: For the treatment of chronic
Disintegrating Prucalopride idiopathic constipation in 27-09-
57 Strips 1/2 mg succinate is adults in whom laxatives fail 2021
equivalent to to provide adequate relief
(Additional Procalopride……
Dosage Form) ………1 mg/2 mg
Itraconazole 65 mg Capsule
(Supra-bioavailable
formulation) is indicated for the
treatment of the following
fungal infections in
Itraconazole immunocompromised and non-
Capsule BP 65 immunocompromised adult
mg (Supra- patients:
Each Capsule
bioavailable
Contains:  Blastomycosis, Pulmonary 08-10-
58 formulation)
Itraconazole……… 2021
and Extra pulmonary
…65 mg
 Histoplasmosis, including
(Additional chronic cavitary pulmonary
Strength) disease and disseminated,
non-meningeal histoplasmosis.

 Aspergillosis, pulmonary and

extra-pulmonary, in patients
who are intolerant of or who are
 refractory to amphotericin B
therapy
The package insert should
contain the following caution
“This Itraconazole Capsules
BP 65mg (Supra-bioavailable
formulation) is not
interchangeable or
substitutable with other
Itraconazole products due to
the differences in dosing
between Itraconazole
capsule BP 65 (Supra
bioavailable formulation) and
other Itraconazole products
"WARNING: To be sold by
retail on the prescription of a
Specialist only”

For treatment of suspected or

Remdesivir laboratory confirmed corona
Injection Each ml contains:
virus disease 2019 (COVID-19)
100mg/ml Remdesivir
in adults and children
(1ml/vial) (Single …………………100
hospitalised with moderate to 08-10-
59 dose vial) mg Alcohol
severe disease 2021
……………….20%
w/v “WARNING: To be sold by
(Additional Benzyl retail on the prescription of
Strength) alcohol………5%w/v specialist for use in Hospital/
Institutional set up only”

For continued treatment of

patients with acute myeloid
leukemia (AML) who
Azacitidine achieved first complete
Tablets 200mg remission (CR) or complete
Each film coated remission with incomplete
tablet contains: blood count recovery (CRi) 14-10-
60 Azacitidine IP following intensive induction 2021
…………………200 chemotherapy and are not
mg able to complete intensive
(Additional
Strength) curative therapy
"WARNING: To be sold by
retail on the prescription
of Oncologist only”
 To reduce the risk of
Empagliflozin Each Film coated cardiovascular death plus
Tablets 10/25mg tablets contains: hospitalization for heart failure in 25-10-
61 Empagliflozin adults with heart failure and 2021
……………………… reduced ejection fraction
(additional ……. 10/25mg
Indication)