List of drugs approved from SND Division from 01.01.2020 to 29.05.

2020

S. Drug Name Composition Indication Date of

No Approval
1 Betahistine Each Orally Indicated in the treatment 02-01-2020
Dihydrochloride Orally Disintegrating Strips of Menier’s syndrome,
Disintegrating Strips contains: Characterized by
16mg /24 mg unilateral or bilateral
Betahistine
tinnitus, vertigo,
(New Dosage form) Dihydrochloride
sensorineural hearing
…….16mg/24 mg
loss
2 Posaconazole Gatro- Each-Gastro-Resistant For Prophylaxis of 03-01-2020
Resistant Tablet 100 Tablet Contains: invasive Aspregilus and
mg Posaconazole…….100 Candida infections in
mg patients who are at high
(Modified Release
risk of developing these
dosage form)
infections due to being
severely
immunocompromised,
such as hematopoietic
stem cell transplant
(HSCT) recipients with
graft-versus-host disease
(GVHD) or those with
hematologic
malignancies with
prolonged neutropenia
form chemotherapy.
Posaconazole Gastro
Resistant tablets are
indicated in patients 13
years of age and older
Warning: To be sold by
retail on the
prescription of
Specialist only.
3 Pirfenidone tablet 600 Each Film coated For the Treatment of 08-01-2020
mg Tablet contains: idiopathic pulmonary
Pirfenidone….600mg fibrosis
(Additional strength)
Warning: To be sold by
retail on the
prescription of
Pulmonologist only.
4 Saroglitazar Tablet Each uncoated tablet Type 2 Diabetes mellitus- 13-01-2020
contains: as an add-on therapy to
2mg/4 mg
Saroglitazar……… 2/4 metformin
(Additional indication) mg

5 Enzalutamide Soft Each soft capsules In the treatment of adult 23-01-2020

Capsule 40 mg contains men with metastic
Enzalutamide…40 mg castration-resistant
(Additional indication)
prostate cancer who are
asymptomatic or mildly
symptomatic after failure
of androgen deprivation
therapy in whom
chemotherapy is not yet
clinically indicated
Warning: To be sold by
retail on the
prescription of
Oncologist only.
6 Canagliflozin 100 mg Each film coated tablet To reduce the risk of 17-02-2020
and 300 mg Tablet contains: major adverse
cardiovascular events
(Additional Indication) Canagliflozin (cardiovascular death,
100mg/300mg nonfatal myocardial
infarction and nonfatal
stroke) in adults with type
2 diabetes mellitus and
established
cardiovascular disease.
7 Norethisterone Acetate Each film coated To arrest bleeding in 24-02-2020
Controlled Release controlled release tablet women with
Tablet 10 mg contains: dysfunctional uterine
(Additional Dosage bleeding due to hormonal
form & Indication) Norethisterone Acetate imbalance.
10mg
8 Lidocaine Each ml contains: Indicated in adults: 25-02-2020
Hydrochloride 2% • For the production of
Solution Lidocaine topical anesthesia of
Hydrochloride 20mg irritated or inflamed
(Additional Dosage mucous membranes of
Form) the mouth and pharynx.
• For reducing gagging
during the taking of X-ray
pictures and dental
impressions.
9 Saroglitazar Tablets Each uncoated tablet Noncirrhoic Non-Alcohol
02-03-2020
4mg contains: Steatohepatitis
 (Additional Indication) Saroglitazar
4 mg
10 For the treatment of
onychymycosis of the
toenail due to
Trichophyton rubrum or
T. mentagrophytes in
Itraconazole Capsule
Each capsule contains: non-
200 mg 03-03-2020
immunocompromised
Itraconazole 200 mg patients
(Additonal Strength)
Warning: To be sold by
retail on the
prescription of a
Specialist only.
11 Reeducation in the risk of
postoperative macular
oedema associated with
Nepafenac Ophthalmic cataract surgery in
Each ml contains:
suspension 0.3% w/v diabetic patients 03-03-2020
Nepafenac 3mg
(Additional Indication) Warning: To be sold by
retail on the
prescription of a
Opthamologists only.
12 Each film coated tablet
Bisoprolol Fumarate For the treatment of
contains:
tablet 1.25 mg congestive heart failure 04-03-2020
Biosoprolol Fumarate (CHF)
(Additional strength)
1.25 mg
13 For the treatment of
idiopathic pulmonary
Pirfenidone Tablets 267 Each film coated tablet fibrosis
& 801 mg (Additional contains: Pirfenidone Warning: To be sold by 04-03-2020
Strength) 267mg/801 mg retail on the
prescription of a
Pulmonologist only.
14 Injection as first-Line
chemotherapeutic agent
for treatment of patients
Pegaspargase Injection Each 5ml vial contains: with acute Lymphoblastic
3750 IU/5ml Pegaspargase Injection Leukemia (ALL) 04-03-2020
(Additional Indication) 3750 IU Warning: To be sold by
retail on the
prescription of a
Oncologist only.
15 Norethisterone Acetate Each film coated To arrest bleeding in 09-03-2020
Controlled Release controlled release tablet women with Heavy
 Tablet 15 mg contains Norethisterone Menstrual Bleeding
Acetate 15 mg (HMB)/abnormal Uterine
(Additional Strength) Bleeding (AUB) due to
hormonal imbalance
Warning: To be sold by
retail on the
prescription of a
Gynaecologist/Obstertr
ician only.
16 Estrogen deficiency
symptoms due to
Estriol Tablets Each uncoated Tablet menopause
1mg/2mg contains: Estriol 09-03-2020
Warning: To be sold by
(Additional strength) 1mg/2mg retail on the
prescription of a
Gynaecologist only.
17 In combination with
cyclophosphamide as a
conditioning regimen
prior to allogenic
hematopoietic progenitor
Busulfan Injection 60
Each 10 ml vial cell transplantation for
mg/10ml 09-03-2020
contains: Buslfan 60mg chronic myelogenous
(Additional Strength) leukemia
Warning: To be sold by
retail on the
prescription of a
Oncologist only.
18 Emergency contraception
within 120 hrs (5 days) of
unprotected sexual
Ulipristal Acetate Tablet Each film coated tablet
intercourse or
30 mg contains Ulipristal
contraceptive failure 11-03-2020
acetate 30 mg
(Additional strength&
Warning: To be sold by
indication)
retail on the
prescription of a
Gynaecologist only.
19 To reduce the risk of
end-stage kidney disease
(ESKD), doubling of
Canagliflozin Tablet Each film coated tablet serum creathinine,
100/300 mg contains: Canagliflozin cardiovascular (CV) 11-03-2020
100/300 mg death, and hospitalization
(Additional Indication)
for heart failure in adults
with type 2 diabetes
mellitus and diabetic
nephropathy with
 albuminuria 300mg/day
20 For the treatment of
Each soft gelatin systemic sclerosis
Nintedanib Soft Gelatin associated interstitial
Capsules 100/150 mg capsule contains:
Nintedanib Lung Disease (SSc-ILD)
20-03-2020
Ethanesulfonate Warning: To be sold by
equivalent to retail on the
(Additional Indication) Nintedanib 100/150 mg prescription of a
Pulmonologist only.
21 For the treatment of
Each Vial contains: advanced colorectal
Oxaliplatin Injection 50
Sterile Solution of cancer.
mg/vial & 100 mg/val
Oxaliplatin 50mg and Warning: To be sold by 29-04-2020
(Additional Dosage 100mg retail on the
Form)
prescription of an
oncologist only.
22 For the treatment of
Polycystic Ovary
Syndrome (PCOS) with
established insulin
resistance
WARNING: To be sold
by retail on the
prescription of a RMP
only

Metformin In the package insert -

Hydrochloride Each Prolonged Special warnings and
Prolonged Release Release Tablets
precautions: Pregnancy: 05-05-2020
Tablets 500mg contains: Metformin
Hydrochloride 500mg “There are no adequate
(Additional Indication)
and well-controlled
studies in pregnant
women with Metformin
and Metformin should not
be used during
pregnancy unless clearly
needed”

23 Olaparib 100 mg and Olaparib is indicated as

150 mg Tablets Each Film coated tablet monotherapy for the
contains: Maintenance treatment of 06-05-2020
Oloaparib…100mg/150 adult patients with
mg. germline BRCA-mutated
(Additional Indication)
metastatic
 adenocarcinoma of the
pancreas whose disease
has not progressed on
first-line platinum-based
chemotherapy

“WARNING: To be sold
by retail on the
prescription of
Oncologist only”

24  For the treatment

of patients with
multiple myeloma
 For the treatment
of patients with
mantle cell
lymphoma who
Brotezomib For have received at
injection 2.5mg/ml Each Vial Contains: least one prior 12-05-2020
Bortezomib 2.5 mg therapy.
(Additional Pack Size)
WARNING: To be sold
by retail on the
prescription of
Oncologist only” which
shall be in red box;