LIST OF NEW DRUGS APPROVED FROM 01-01-2018 to TILL 16-03-2018 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