Drugs approved from 1st Jan 2014 till present (nov 14)

S.No

Drug

Indication

Date

1

Tolterodine Tartrate Extended release tablets 2mg/4mg (Additional Dosage Form)

For the treatment of overactive bladder with symptoms of urge urinary incontinence, urinary incontinence, urgency and frequency.

31.01.14

2

Bortezomib for injection 3.5mg (Sub-cutaneous route of administration as an alternate to intravenous route) (Additional route of administration)

Same as already approved

28.01.14

3

Paclitaxel Injection Concentrate for Nanodispersion 100mg and 300mg (Additional Dosage Form)

For the treatment of Breast cancer after failure of combination therapy metastatic disease or relapse within six months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated.

22.01.14

4

Heparin Sodium Topical Solution 1000 IU/ml (Additional Dosage Form)

For the management of post infusion superficial thrombophlebitis.

16.1.2014

5

Simethicone Orally disintegrating strip 62.5mg

For the treatment of flatulance and as adjuvant in hyperacidity.

14.11.2010

6

Eltrombopag Olamine tablet 25/50mg (Additional Indication)

Indicated in patients with chronic hepatitis C Virus (HCV) infection for the treatment of thrombocytopenia to: Enable the initiation of interferon based therapy, optimise interferon based therapy.

07.04.2014

7

Decitabine lyophilised powder for injection 50mg/20ml vial (additional indication)

For the treatment of adult patients aged 65 years and above with newly diagnosed de novo or secondary acute myeloid leukemia (AML), according to World Health Organisation (WHO) classification, who are not candidates for standard induction chemotherapy.

09.04.2014

8

Glycopyrronium bromide inhalation powder hard capsule with inhaler. Each capsule contains 63mcg Glycopyrronium bromide eq. to Glycopyrronium 50 mcg.

Indicated as a once daily maintenance bronchodilator treatment to relieve symptoms of patients with Chronic Obstructive Pulmonary Disease (COPD).

01.04.2014

9

Micafungin sodium for injection 100mg/vial (Additional Strength)

Treatement of patient with candidemia,acute Disseminated Candidiasis, Candida Peritonitis and abscesses.Treatment of patients with Esophageal Candidiasis,Prohylaxis of Candidia and Aspergillus Infections in patients undergoing Hemopoeitic stem cell transplantaion.Treatment of patient with Fungemia, Respiratory mycosis, Gastrointestinal mycosis caused by Aspergillus sp..

2.05.2014

10

Apixaban tablets 2.5mg/5mg      (Additional Strength & Additional Indication)

Prevention of stroke and systemic embolism in adult patients with non-valvular artrial fibrillation (NVAF), including those with one or more risk factors, such as prior stroke or transient ischemic attack (TIA); age≥75 years; hypertension; diabetes mellitus; symptomatic heart failure (NYHA class≥II). Compared to warfarin apixaban also results in less bleeding, including intracranial hemorrhage.

16.05.2014

11

Mometasone furoate nasal spray 50 mcg/actuation (Additional Indication)

For the treatment of nasal symptoms of seasonal allergic and perennial allergic rhinitis, in adults and pediatric patients 2 years of age and older.

21.05.2014

12

Micronised Purified Flavonoid 1000mg (MPFF). "Each film coated tablet contains diosmin 900mg and flavonoids expressed as Hesperidine 100 mg of Micronised Purified Flavonoid fraction of Rutaceae 1000mg (MPFF)"

Acute hemorrhoid piles

28.11.13

13

Gemcitabine HCl injection ready to use infusion bags

Gemcitabine HCL equivalent to Gemcitabine 10mg per mL

(100,120,130,140,150,160,170,180,190 and 200mL)

Ovarian cancer-Gemcitabine injection in combination with carboplatin is indicated for the treatment of patients with advanced ovarian cancer that has replaced at least 6 months after completion of platinum based therapy. Breast Cancer-Gemcitabine injection in combination with Paclitaxel is indicated for the first line treatment of patients with metastatic breast cancer after failure of prior anthracycline containing adjuvant chemotherapy, unless anthracyclinces were clinically contraindicated.   Non-small cell lung concer-Gemcitabine injection is indicated in combination with cisplatin for the first line treatment of patients with inoperable, locally advanced (Stage IIIA or IIIB), or metastatic (stage IV) non-small cell lung cancer.                     Pancreatic cancer-Gemcitabine injection is indicated as first-line treatment for patient with locally advanced (nonresectable Stage II or Stage III) or metastatic (Stage IV) adenocarcinoma of the pancreas.Gemcitabine injection is indicated for patients previously treated with 5 -FU.

17.06.2014

14

Tadalafil Orally Disintegrating Strip 10mg & 20mg (Additional dosage form)

For erectile dysfunction

30.07.2014

15

Hydroxychloroquine Sulphate USP 400 mg tablets (Additional Indication)

As an adjunct to diet and exercise to improve glycemic control of patients on metformine, sulfonylurea combination in patients with Type II Diabetes.

28.07.2014

16

Nevirapine Extented release tablet 400mg (Additional Strength)

For use in combination with other anti-retroviral agents for the treatment of HIV-1 infection in adults

01.07.2014

17

Artesunate injection. Each combipack contains: "Artesunate for injection 120mg ( Each vial contains Artesunate IP 120mg), Sodium bicarbonate injection IP 5%w/v (Each 2ml ampoule contains: Sodium Bicarbonate IP 5% w/v), Sodium chloride Injection IP 0.9% w/v (Each 10ml ampoule contains: Sodium chloride IP 0.9% w/v)" 

Promoted for use in severe malaria including cerebral malaria as a second line in chloroquine resistant malaria cases only.

13.11.2013

18

Cerebrolysin solution for injection. Each ml contains: Porcine brain derived peptide preparation (Cerebrolysine concentrate) 215.2mg

For amelioration of cranial injury, cerebrovascular pathological sequelae and aprosexia in dementia.

25.07.2014

19

Artesunate powder for injection 60mg/vial alongwith 6ml ampoule of phosphate buffer solution (pH 8.0;0.30M)

For the treatment of severe Falciparum malaria in areas where there is evidence if quinine resistance

02.07.2014

20

Montelukast sodium chewable tablet 4mg/5mg and Montelukast sodium film coated tablet 10mg.

As add on therapy in mild to moderate asthma inadequately controlled by inhaled corticosteroids and short active B2 agonist, Exercise induced bronchoconstriction.

26.02.2002

21

Lactobacillus brevis CD2 Lozenges 100mg (corresponding to not less than 1 billion) of live, lyophilised, lactic acid bacteria, Lactobacillus brevis CD2.                     (Additional indication)

Prevention of radiotherapy and chemotherapy induced oral mucositis in cancer patients

9/8/2014

22

Rivaroxaban tablet 15/20mg

(Additional strength/indication)

1. Treatment of deep vein thrombosis and for prevention of recurrent  DVT and pulmonary embolism. 2. For the prevention of stroke and systemic embolism in patient with non-valvular arterial fibrillation.

2.9.14

23

Hydroxychloroquine Sulphate Tablet 300mg (Additional strength/indication)

Indicated for the treatment of  patietns  with lower body weight i.e 45 to 60kg  in Rhemuatoid arthritis, Systemic Lupus Erythematosus & Polymorphic Light Eruption

9/8/2014

24

Ginkgo biloba extract   Tablet 120mg       (Additional strength)

For the treatment of dementia, vertigo and tinnitus in adult patients.

9/12/2014

25

Bendamustine Hydrochloride lyophilised  injection 25mg

(Additional strength)

Treatment of patients with chronic lymphocytic leukemia

19.9.2014

26

Metformin ER tablet 750mg

(Additional strength)

As an adjunct to diet and exercise to improve glycemic control  in adult patients with Type II Diabetes

25.9.14

27

Sorafenib tosylate tablet 200mg

(Additional indication)

For the treatment of patients with locally advanced or metastatic differentiated thyroid carcinoma refractory to radioactive iodine.

25.9.14

28

Deferasirox Dispersible tablet 100/400mg (Additional indication)

Treatment of chronic iron overload in patients with non-transfusion dependent thalassemia (NTDT) syndromes aged 10 years and older.

26.9.2014

29

IMATINIB mesilate100/400mg tablets and 100 mg capsules

(Additional indication)

Treatment of Paediatric patients with newly diagnosed Philadelphia chromosome positive acute LymphoblasticLeukaemia (Ph+ALL) integrated with chemotherapy

9/9/2014

30

Tapentadol Extended release tablet 100/150/200mg (Additional strength)

For use in in-patients under hospital setting for severe acute pain for a period not exceeding 5 days

9.12.13