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LIST OF NEW DRUGS APPROVED FROM 01-01-2018 to TILL 30-06-2018 BY NEW DRUGS DIVISION

LIST OF NEW DRUGS APPROVED FROM 01-01-2018 to TILL 30-06-2018 BY NEW DRUGS DIVISION


S.No

Name of drug

Indication

Date of issue

1

Tenofovir Alafenamide Hemifumarate Bulk & Emtricitabine 200mg/200mg + Tenofovir Alafenamide 10/25 mg Tablets

In combination with other antiretroviral agents for treatment of Human Immunodeficiency Virus type-1 (HIV-1) infection in adults and adolescents with aged 12 years and older

10.01.2018

2

Clofarabine Bulk & Injection 20 mg/20ml vial

For the treatment of patients 1 to 21 years old with relapsed or refractory acute lymphoblastic leukemia after at least two prior regimens. This indication is based upon response rate

16.01.2018

3

Denaverine Hydrochloride 40 mg Injection (Vet.)

cattle : Facilitation of parturition in heifers; activation of icattle : Facilitation of parturition in heifers; activation of interrupted parturitions; insufficient opening of the soft birth canal; narrowness of the cervix of first and second degree after correction of uterine torsions; improvement of the conditions for foetotomy; regulation of labour contractions of the uterus

Dogs: Activation of Interrupted parturition

16.01.2018

4

Netupitant 300 mg + Palonosetron 0.5 mg Capsule

For the prevention of acute and delayed nausea and vomiting associated with highly emetogenic Cisplatin-based cancer chemotherapy 

- For the prevention of acute and delayed nausea and vomiting associated with moderate emetogenic cancer chemotherapy in adult

20.02.2018

5

Fipronil 6.1 % m/v + Permethrin 54.5% m/V spot on solution for Dog (Vet.)

In dogs, to be used against infestations  with fleas and /or ticks when repellent ( anti feeding) activity is necessary against sand-files and/ or mosquitoes

20.02.2018

6

Praziquantel 0.0065 g + Abamectin 0.00025 g tablets for cat (Vet)

In infestation of cats with endoparasites tapeworms (teniae), flukes, roundworms (nematodes);  with ectoparasites- lice, fleas, pasture ticks, notedric mange (feline scabies),  “walking” dandruff (cheyletiellosis) and other mange, and particularly in cases of complex endo and ectoparasitic invasion.

20.02.2018

7

Cadexomer Iodine Bulk & Powder 100 % w/w (contain 0.9 % w/v Iodine) or Cadexomer Iodine Ointment 500 mg (contains 0.9% w/v iodine)

For the treatment of chronic exuding wounds such as leg ulcers, pressure ulcers and diabetes ulcers infected traumatic and surgical wounds

05.03.2018

8

Dalfampridine Bulk & Film coated extended release tablet 10 mg

For  treatment to improve walking in patients with multiple Sclerosis (MS)

12.03.2018

9

Ulipristal Acetate 5 mg tablets

For the pro-operative treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age and intermittent treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age

14.03.2018

10

Ulipristal Acetate bulk & 5 mg tablets

For the pro-operative treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age and intermittent treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age

02.04.2018

11

Riociguat bulk & 0.5mg/1.0mg/1.5mg/2.0mg/2.5 mg tablet

For the treatment of persistent/ recurrent chronic Thromoembolic pulmonary Hypertension (CTEPH) WHO Group 4) After surgical treatment or imoperable CTEPH to improve exercise capacity and WHO function

16.04.2018

12

Baricitinib 2mg/4mg film coated tablets

For the treatment of moderate to severe active rheumatoid arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more disease modification anti-rheumatic drugs. Baricitinib  may be used as monotherapy or in combination with methotrexate

07.05.2018

13

Vortioxetine Hydrochloride 5mg/10 mg/15mg/20mg film coated tablets

For the treatment of major depressive disorder in adult

14.05.2018

14

Vardenafil Hydrochloride Trihydrate(BULK) & Vardenafil 2.5mg/5mg/10mg/20mg

Tablets Treatment of erectile dysfunction in adult men.

11.06.2018

15

Trientine Hydrochloride bulk  & 250mg caspule

For the treatment of Wilson’s disease (hepatolenticular degeneration) in patients intolerant to Penicillamine. It should be used when continued treatment with Penicillamine is no longer possible because of intolerable or life endangering side effect

11.06.2018