List of drugs approved from SND Division from 01.01.2020 to31.07.2020

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 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 Capsule Each capsule contains: non- 200 mg immunocompromised 03-03-2020 Itraconazole 200 mg (Additonal Strength) patients 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 contains: For the treatment of tablet 1.25 mg congestive 04-03-2020 Biosoprolol Fumarate (Additional strength) (CHF) 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 Warning: To be sold by 09-03-2020 (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 acetate 30 mg 11-03-2020 (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 death, and hospitalization (Additional Indication) 100/300 mg 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 (Additional Indication) retail on the Nintedanib 100/150 mg prescription of a Pulmonologist only. 21 For the treatment of Each Vial contains: advanced colorectal Oxaliplatin Injection 50 cancer. mg/vial & 100 mg/val Sterile Solution of 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 Release Tablets Prolonged Release 05-05-2020 Tablets 500mg contains: Metformin precautions: Pregnancy: 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. (Additional Indication) germline BRCA-mutated 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 Each Vial Contains: injection 2.5mg/ml 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;

25  For the prevention of caries in children and adults as part of a comprehensive control programme, for the: - prevention of recurring (or marginal) caries Sodium Fluoride varnish - prevention of (50mg/ml) (Dental Each ml of Dental progression of Suspension contains: Suspension) caries 05-06-2020 Sodium Fluoride……50 - prevention of (New Dosage Form) mg decalcification around orthodontic appliances - prevention of pit and fissure (occlusal) caries.  For the desensitisation of hypersensitive teeth as part of a treatment regimen which includes the daily use of a suitable toothpaste.

Warning:“To be sold by retail on the prescription of a Dentist only” 25 1. For the treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated.

2. For the adjuvant treatment of node- positive breast cancer administered sequentially to standard doxorubicin- containing Paclitaxel Lipid Each vial combination Suspension for injection chemotherapy. 100 mg/vial contains:Paclitaxel 16-06-2020 ………100 mg 3. As first-line and (Additional Strength) subsequent therapy for the treatment of advanced carcinoma of the ovary. As first-line therapy, it is indicated in combination with cisplatin.

4. In combination with cisplatin, is indicated for the first-line treatment of non-small cell lung cancer in patients who are not candidates for potentially curative surgery and/or radiation therapy.

5. For the second-line treatment of AIDS- related Kaposi’s sarcoma

Warning:“To be sold by retail on the prescription of a Oncologist only” 26 For the Treatment of Itraconazole Oral Solution Orophyaryngeal and Each ml Contains: Esophageal candidiasis 10 mg/ml 25-06-2020 Itraconazole………10 mg Warning:“To be sold by (New Dosage Form) retail on the prescription of a Specialist only” 27 For symptomatic treatment of allergic rhino- Each uncoated Bilastine Orodispersible conjunctivitis (seasonal and orodispersible tablet perennial) and urticarial. Tablet 10 mg 25-06-2020 contains: Bilastine…… Bilastine is indicated in (New Dosage Form) 10 mg children aged 6 to 11 years with a body weight of at least 20 kg 28 for the treatment of Systematic aspergillosis, candidiasis, cryptococcosis, sportrichosis, paracoccidioidomycossis, blastomycosis and other rarely occuring systemic or tropical mycosis "WARNING: To be sold by retail on the prescription of a Specialist only”.

Itraconazole 50 mg Capsule Each capsule contains: Caution: “This Itraconazole 30-06-2020 (Modified Dosage Form) Itraconazole……50 mg Capsules 50mg has equivalent bioavailability with that of itraconazole capsules 100mg. One capsule of this Itraconazole Capsule 50mg is therapeutically equivalent to one 100mg capsule of conventional Itraconazole capsules100mg. The recommended dose of this Itraconazole Capsules 50mg is therefore half the recommended dose for conventional itraconazole capsules 100 mg. This Itraconazole Capsules 50mg and conventional Itraconazole Capsules 100mg are not interchangeable”.

29 • Nosocomial Pneumonia like Hospital Acquired Pneumonia (HAP)/Ventilator Associated Pneumonia • Urinary Tract Infections like Each Vial Contains Complicated Urinary Meropenem Trihydrate Tract Infections Meropenem dry powder Equivalent to Meropenem • Intra-Abdominal 02-07-2020 for injection 2000 mg 2000mg Sodium Carbonate infection like Complicated Equivalent to sodium (Na+0 Intra-Abdominal Infection 180.4mg • Meningitis like Acute Meningitis • Septicemia • Empiric Treatment of Presumed infection in Adult Patients with Febrile Neutropenia

30 6. Dapagliflozin is Each Film coated tablet indicated in contains: adults for the treatment of Dapagliflozin 10 mg Dapagliflozin Propanediol 03-07-2020 Monohydrate equivalent heart failure to Dapagloflozin………10 with reduced mg ejection fraction.

31 Each Vial Contains: Ceftaroline For the tratment of the Ceftaroline fosamil Fosamil………………..6 adults with complicated powder for concentrate for 00mg 06-07-2020 skin and soft tissue solutin for infusion L- infections (Cssti) Arginine………………… ………..395mg 32 Each soft Gelatin capsule contains: Nintedanib For the treatment of other Ethanesulfonate chronic fibrosing interstitial Nintedanib 100mg/150mg 09-07-2020 equivalent to Lung Diseases (ILDs) with Nintedanib……..100mg/1 a Progressive phenotype 50mg 33 Each film coated For the treatment of prolonged release tablet chronic stable contains: pectoris in patients with Ivabradine PR Tablets Ivabradine hydrochloride and 14-07-2020 10/15mg equivalent to treatment of chronic heart Ivabradine……………….10 mg fail

/ 15 mg. ure. 34 Each Orally For use in pediatric age Paracetamol Orally Disintegrating Strip 14-07-2020 Disintegrating 60/120 mg Contains: group, for symptomatic Paracetamol……………… treatment of pain and fever ……….60mg / 120 mg 35 As an alkalising agent in Sodium Citrate Granules Each sachet (5.6g) cystitis in women 16-07-2020 4.0 gm Contains: Sodium Citrate 4.0 g 36 In adult (>18 years) and Each uncoated tablet pediatric patients (12 years contains: to less than 18 years of age and weighing at least 30 kg) as part of combination Bedaquiline Tablet 100 Bedaquiline fumarate equivalent therapy of pulmonary 16-07-2020 mg tuberculosis (TB) due to to……………………100 multi-drug resistant mg of Mycobacterium tuberculosis. Bedaquiline

37 Each hard gelatin capsule contains: Trimetazidine For the treatment of Hydrochloride Extended Trimetazidine Ischaemic heart disease 21-07-2020 Release Capsules 80mg hydrochloride (angina pectoris, sequelae (as extended release of infarction). pellets)… 80 mg 38 For the treatment of patients with hepatocellular carcinoma (HCC) who Regorafenib Tablet 40 mg Each film coated tablet contains: Regorafenib…..40 have been previously 03-08-2020 (Additional Indication) mg treated with Sorafenib Warning “To be sold by retail on the Prescription of an Oncologist only

39 For the symptomatic Baclofen Extended Each uncoated extended treatment of neuronal Release tablet 30mg release tablet spasticity due to multiple 04-08-2020 contains:Baclofen….30 sclerosis, spinal chord, (Additional dosage & pathology & injury Strength) mg

40 For the treatment of adult patients with active psoriatic arthritis (PsA) who have had an inadequate response or intolerance to Tofacitinib Tablet 5 mg Each film coated tablet methotrexate or other contains: Tofacitinib citrate non-biologic disease 04-08-2020 equivalent to tofacitinib…..5 modifying antirheumatic mg (Additional Indication) drugs (DMARDs) Warning “To be the prescription of a Rheumatologist or Specialist in Internal Medicine only” 41 For the treatment adults with metastatic castration-resistant Enzalutamide 80 mg prostate cancer capsules Each hard gelatin capsule (mCRPC) whose disease contains: has progressed on or 06-08-2020

Enzalutamide….80mg after Docetaxel therapy. (Additional strength) Warning “To be sold by retail on the Prescription of an Oncologist only” 42 Treatment of pain Oxaceprol Sustained Each film coated SR associated with Release Tablet 600 mg tablet contains: osteoarthritis of knee in 07-08-2020 adult patients (Additional strength) Oxaceprol……600 mg

43 Olaparib is indicated as monotherapy for the treatment of adult patients with metastatic castration-resistant prostate cancer and Each film-coated tablets homologous Olaparib 100/150 mg contains: recombination repair gene mutations (germline 17-08-2020 Olaparib……100mg/15 (Additional Indication) and/or somatic) who 0 mg have progressed following a prior new hormonal agent. Warning “To be sold by retail on the Prescription of an Oncologist only”

44 Levofloxacin Dispersible Each dispersible tablet Indicated in combination with Tablets 100 mg contains: other anti-tuberculosis 18-08-2020 Levofloxacin agents, for the treatment of (New Dosage Foam) hemihydrate tuberculosis caused by Equivalent to Levofloxacin Mycobacterium tuberculosis ……………….100 mg in children.

Warning “To be sold by the prescription of a Medical Specialist only” 45 It is indicated in all forms of (postencephalitic, arteriosclerotic and idiopathic). It is often useful as adjuvant therapy Each uncoated tablet when treating these forms Trihexyphenidyl contains: of Parkinsonism with Hydrochloride 1 mg Trihexyphenidyl levodopa. 18-08-2020 hydrochloride Trihexyphenidyl is also

…………………………… indicated to control (Additional strength) extrapyramidal disorders due ….1 mg to central nervous system drugs such as reserpine and the phenothiazines. Warning “To be sold by the prescription of Neurologist only” 46 Olaparib in combination with bevacizumab is indicated for the Maintenance treatment of adult patients with advanced high-grade epithelial ovarian, fallopian tube or Each film-coated tablets primary peritoneal Olaparib 100/150 mg cancer who are in contains: response (Complete 21-08-2020 Olaparib……100mg/1 (Additional Indication) response or partial 50 mg response) to first-line platinum-based chemotherapy with bevacizumab.

Warning “To be sold by retail on the Prescription of an Oncologist only” 47 For the treatment of Ferric Carboxymaltose iron deficiency in adults Solution for when oral iron Injection/Infusion Each ml contains: preparations are 20mg/vial Ferric Carboxymaltose ineffective or cannot be 27-08-2020 equivalent to Elemental used. Iron….50 mg. (Additional Pack Size)

48 For the short-term and non-continuous chronic treatment of Lipid Based Tacrolimus symptomatic lichen Each gram contains: Ointment 0.1% w/w planus (oral and Tacrolimus Monohydrate 28-08-2020 Equivalent to mucosal forms) in non- Tacrolimus…....0.1% w/w immunocompromised

(Additional indication) patients Warning “To be the prescription of a Dermatologists only”