LIST OF NEW DRUGS APPROVED FROM 01-01-2018 to TILL 30-09-2018 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 |
16 | Apremilast bulk & Apremilast 10mg, 20mg, 30mg - film coated tablets | Indicated for the treatment of patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy | 25.06.2018 |
17 | Gadoteridol - 279.3mg/ml for injection Pack size – 10ml, 15ml and 20ml. | Lesions with abnormal vascularity in the brain (intracranial lesions ), spine and associated tissues in adults and paediatric patients over 2 years of age Lesions in the head and neck in adults | 25.06.2018 |
18 | Fipronil 50mg/134mg/268mg/402 mg spot on solution for cats and dogs | For treatment of flea and tick infestation in cats and dogs (for veterinary use only) | 25.06.2018 |
19 | Emtricitabine 200mg and tenofovir alafenamide 25mg tablets | In combination with other antiretroviral agents for the treatment of adults and adolescents (aged 12 years and older with body weight at least 35kg) infected with human immunodeficiency virus type I (HIV-I). | 25.06.2018 |
20 | Each single use 20 ml vial contains: Ceftolozane 1gm (equivalent to 1.147 gm of Ceftolozane sulfate) and Tazobactam 0.5gm (equivalent to 0.537 gm of Tazobactum Sodium) | Indicated for the treatment of patients 18 years or older with the following infections caused by designated susceptible microorganisms:
| 06.08.2018 |