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LIST OF NEW DRUG APPROVED FROM 01-01-2017 to TILL 15-01-2018 BY NEW DRUGS DIVISION

LIST OF NEW DRUG APPROVED FROM 01-01-2017 to TILL 15-01-2018 BY NEW DRUGS DIVISION


S.No

Name of drug

Indication

Date of issue

1

Hydrocortisone Aceponate 0.584mg/ml Cutaneous Spray Solution (Vet.)

For symptomatic treatment of inflammatory and pruritic dermatosis in dogs.

06.01.17

2

Dexlansoprazole Delayed Release Capsule 30/60mg & Bulk

For the treatment of

i)  Healing of all grades of erosive esophagitis (EE).

ii)  Maintaining healing of EE and relief of heartburn.

iii)  Treating heartburn associated with symptomatic non-erosive gastroesophageal reflux disease (GERD).

16.01.17

3

Carfilzomib Sterile Lyophilized Powder for Injection 60mg/vial (50ml vial)

Relapsed or refractory multiple myeloma

    •       Carfilzomib for injection is indicated in combination with dexamethasone or with lenalidomide plus dexamethasone for the treatment of patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy.

    •       Carfilzomib for injection is indicated as a single agent for the treatment of patients with relapsed or refractory multiple myeloma who have received one or more lines of therapy.

17.01.17

4

Dabrafenib 50mg/75mg Capsules

(Dabrafenib Mesylate)

As a single agent for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E mutation as detected by an appropriate test.

In combination with Trametinib for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E mutation as detected by an appropriate test.

18.01.17

5

Trametinib 0.5mg/2mg Tablets

(Trametinib Dimethyl Sulfoxide)

As a monotherapy and in combination with Dabrafenib for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E mutation as detected by an appropriate test.

18.01.17

6

Alectinib 150mg Capsules (Alectinib Hydrochloride)

For the treatment of patients with anaplastic lymphoma kinase (ALK)-Positive, metastatic non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to Crizotinib.

23.01.17

7

Eliglustat 84mg Capsules

(Eliglustat Tartrate or Hemitartrate Salt)

For the long term treatment of adult patients with Gaucher disease type 1 who are CYP2D6 extensive metabolizers (EMs), intermediate metabolizers (IMs), or poor metabolizers (PMs) as detected by an appropriate test.

31.01.17

8

Pasireotide long-acting release 20/40/60mg powder for suspension for injection (Additional Indication) (Pasireotide pamoate)

For the treatment of patients with acromegaly who have had an inadequate response to surgery and/ or for whom surgery is not an option.

14.02.2017

9

Etonogestrel 68 mg implant

For use by women to prevent pregnancy.

15.02.2017

10

Bepotastine Besilate 1.5 %w/v Ophthalmic solution

For the treatment of itching associated with allergic conjunctivitis

22.02.2017

11

Dienogest 2mg Tablets

For the management of Pelvic pain associated with Endometriosis

09.03.2017

12

Eprinomectin 0.5% for beef and dairy cattle (vet.)

It is indicated for the treatment and control of gastrointestinal roundworm (including inhibited Ostertagia ostertagi), lungworm, grubs, sucking and biting lice, chlorioptic and sarcoptic-mange mites, and horn flies in beef and dairy cattle of all ages, including lactating dairy cattle.

14.03.2017

13

Bepotastine Besilate 10 mg Tablets

For the treatment of allergic rhinitis

27.03.2017

14

Prucalopride 1mg/2mg Tablet & Bulk  (Prucalopride Succinate)

For the treatment of chronic idiopathic constipation in adults in whom laxatives fail to provide adequate relief

13.04.2017

15

Teriflunomide  14 mg tablets

For the treatment of patients with relapsing form of multiple sclerosis

13.04.2017

16

Pomalidomide 1mg/2mg/3mg/4mg Capsules & Bulk

In combination with dexamethasone, for patient with patient multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on or within 60 days of completion of the last therapy.

01.05.2017

17

Sofosbuvir 400 mg +Velpatasvir 100 mg Tablet

For the treatment of adult patients with                                                                                                                                               -chronic Hepatitis C virus, Genotype 1,2,3,4,5 or 6 infection.       -Without cirrhosis or with compensated cirrhosis                           -With decompensated with chronic for use in combination with Ribavirin.

04.05.2017

18

Velpatasvir Bulk

 

04.05.2017

19

Osimertinib 40 mg/80 mg Film coated Tablets

(Osimertinib Mesylate)

For the treatment of patient with metastatic epidermal growth factor receptor (EGFR) T790 M mutation-positive non-small cell lung cancer (NSCLC), as detected by an appropriate test, whose disease has progressed on or after EGFR TKI therapy

29.05.2017

20

Argatroban Hydrate Bulk & Injection 250 mg/2.5 ml

1) For prophylaxis or treatment of thrombosis   in adult patients with Heparin induced thrombocytopenia (HIT).                             2) As an anticoagulant in adults patients with or at risk for heparin-induced thrombocytopenia undergoing percutaneous coronary intervention (PCI)

30.05.2017

21

Fluralaner chewable tablets 112.5 mg/250 mg/500mg/1000mg/1400 mg

For the treatment of tick and flea infestations on dogs for 12 weeks. This veterinary medicinal product is a systemic insecticide and acaricide with a long duration of action that  provides immediate and persistent tick (adult and juvenile Ixodes ricinus, Ixodes hexagonus, Ixodes scapularis, Ixodes holocyclus, Dermacentor reticulates, Dermacentor variabilis and Rhipicephalus sanguineus) and flea (Ctenocephalides felis and Ctenocephalides canis) killing activity for 12 weeks.

 

Fleas and ticks must attach to the host and commence feeding in order to be exposed to the active substance. the onset of effect is within 8 hours of attachment for fleas (C. felis) and 12 hours of attachment for ticks (I. ricinus)

 

The product effectively controls environmental flea population in area to which treated dogs have access.

 

The product can be used as part of an treatment strategy for the control of Flea Allergy Dermatitis (FAD)

30.5.2017

22

Fluticasone Furoate (100 mg mcg) and Vilanterol Trifenatate (25 mcg) powder for inhalation

Indicated for the maintenance treatment of the airflow obstruction in patients with chronic obstructive pulmonary disease (COPD) including chronic bronchitis and/ or emphysema and to reduce exacerbation of COPD in patients with an exacerbation history.

29.06.2017

23

Mirabegron Prolonged Release Tablet 25 mg /50 mg

Symptomatic treatment of urgency, increased micturition frequency and / or urgency incontinence as may occur in patients with over active bladder (OAB) Syndrome

12.07.2017

24

Delamanid 50 mg tablet

For the use as part of an appropriate combination regimen for pulmonary multi-drug resistant tuberculosis (MDR-TB) in adult patients when an effective treatment regimen cannot otherwise be composed for reasons of resistance or tolerability

02.08.2017

25

Mirabegron Prolonged Release Tablet 25 mg /50 mg & Bulk

Symptomatic treatment of urgency, increased micturition frequency and / or urgency incontinence as may occur in patients with over active bladder (OAB) Syndrome

18.08.2017

26

Efonidipine Hydrochloride Ethanolate Bulk & Tablets 10 mg/20mg/40mg

Indicated for the management of

• Hypertension

• Renal parenchymal hypertension 

• Angina

28.08.2017

27

Brivaracetam Film Coated Tablets 50mg/75mg/100mg

As adjunctive therapy in the treatment of partial -onset seizures in patients 16 years of age and older with epilepsy

07.09.2017

28

Treosulfan Bulk & injection 5g/vial

For the conditioning treatment prior to haematopoetic stem-cell transplantation

26.09.2017

29

Ribociclib 200 mg Film coated Tablets

In combination with an aromatase inhibitor as initial endocrine-based therapy for the treatment of post menopausal women with the hormone receptor (HR)-Positive, human epidermal growth factor receptor 2 (HER2)-Negative advanced or metastatic breast cancer

27.09.2017

30

Dienogest Bulk & 2mg Tablet

For the management of Pelvic pain associated with Endometriosis

28.09.2017

31

Apremilast bulk & film coated tablets 10 mg/20 mg/30 mg

for treatment of patients with moderate to severe plaque psoriasis who are candidate for phototherapy or systemic therapy

13.10.2017

32

Arbekacin bulk & Injection 200mg/4ml

Treatment of following infections caused by Methicillin resistant Staphylococcus aureus (MRSA)", sepsis pneumonia

20.10.2017

33

Benestermycin Intra-mammary suspension (vet.)

For the treatment of subclinical mastitis at drying off, and the prevention of new bacterial infections of the udder during the dry period in dairy cows, caused by bacteria susceptible to penicillin and framycetin

03.11.2017

34

Midostaurin 25 mg Capsules

• In combination with standard induction and consolidation chemotherapy followed by single agent in maintenance of therapy for adult patients with newly diagnosed with acute myeloid leukemia (AML) who are FLT-3 Mutation positive.

• For the treatment of adult patients with advanced systemic mastocycosis (Advanced SM)

09.11.2017

35

Tenofovir Alafenamide Fumarate bulk & 25 mg capsules

For the treatment of chronic Hepatitis B virus infection in adults with compensated liver disease

10.11.2017

36

Arteolane Maleate and Piperaquine phosphate Dispersible tablets (37.5 mg +187.5 mg

Indicated in children aged 6 months to 12 years for the treatment of :

- Acute uncomplicated Plasmodium falciparum malaria infection

- Acute uncomplicated Plasmodium Vivax malaria infection

24.11.2017

37

Macitentan Bulk and Tablets 10 mg

Macitentan is an endothelin receptor antagonist (ERA)l indicated for the treatment of Pulmonary arterial hypertension (PAH, WHO group I) to delay disease progression

07.12.2017