Directorate General of Health Services Office of Drugs Controller General (India) (Biological Division)

Transcription

1 Directorate General of Health Services Office of Drugs Controller General (India) (Biological Division) List of r-dna drug products approved in the country (Form 45 and 45A) from 1 st Jan 2015 to 30 th Jun 2016 S. Name of firm No 1 M/s Lupin Limited 2 M/s Bayer Pharmaceuticals 3 M/s Novo Nordisk India Pvt 4 M/s Roche Products (India) Pvt. Date of approval Permission No. Name of the Drugs IMP-13/2015 Insulin Glargine Inj. Indication Insulin Glargine is indicated for once daily subcutaneous administration for treatment of adult patient with Type 1 Diabetes Mellitus or Type 2 Diabetes Mellitus who require basal (long acting) insulin for the control of hyperglycemia IMP-40/2015 Aflibercept Indicated for the treatment of Neovascular (wet) age-related macular degeneration (wet AMD) BULK-65/2015 Insulin Crystals NA IMP-058/2015 Interferon alfa- 2a (Roferon A) Neoplasm of lymphatic and hematopoietic system: hairy cell leukemia, Multiple Myeloma, cutaneous T-cell lymphoma, Philadelphia chromosome positive chronic myelogenous leukemia, thrombocytosis associated with myeloproliferative

2 diseases. Roferon-A is indicated as adjuvant treatment to chemotherapy (with or without radiotherapy) in patients with low grade non- Hodgkin s lymphoma. Solid Neoplasm: AIDS-related Kaposi s sarcoma in patients without history of opportunistic infection, advance renal cell carcinoma, metastatic malignant melanoma, surgically resected malignant melanoma without nodal or distant metastases. Viral Diseases: patients with chronic hepatitis B, who have elevated serum ALT and marker for viral replication, i.e. those who are positive for HBV-DNA, DNA polymerase or HBeAg without liver decomposition patients with chronic hepatitis C who are positive for HCV antibodies and have elevated serum alanine aminotransferase (ALT) without liver decomposition; condylomata acuminate. 5 M/s Novartis IMP-126/2015 Secukinumab For the treatment of moderate to

3 Healthcare Pvt 6 M/s Novo Nordisk India Pvt 7 M/s Gland IMP-154/2015 Insulin degludec/liragl utide Bulk-177/2015 Zinc Insulin severe Plaque Psoriasis in adult Patients who are candidates for systemic Therapy. For the treatment of adults with type 2 diabetes mellitus. Pharma Crystals 8 M/s Sandoz IMP-188/2015 Secukinumab For the treatment of moderate to severe Plaque Psoriasis in adult Patients who are candidates for systemic Therapy. 9 M/s Novo Nordisk India Pvt 10 M/s Glaxo Smith Kline pharmaceuticals ltd IMP-182/2015 Turoctocog alfa Treatment and Prophylaxis of bleeding in patients with haemophilia A (Cogential factor) IMP-234/2015 Albiglutide powder NA Albiglutide is indicated for the treatment of type 2 diabetes mellitus in adults to improve glycemic control as: Monotherapy: when diet and exercise alone do not provide adequate glycemic control in patients for whom use of metformin is considered inappropriate due to contraindications or intolerance. Add-on combination therapy: In combination with other glucoselowering medicinal products including basal insulin, when these, together with diet and exercise, do not provide

4 11 M/s Johnson & Johnson Limited 12 M/s UCB India 13 M/s UCB India adequate glycemic control IMP-257/2015 Siltuximab Siltuximab (SYLVANT ) is indicated for the treatment of patients with Multicentric Castleman s Disease (MCD) who are human immunodeficiency virus (HIV) negative and human herpesvirus-8(hhv-8) negative IMP-026/2016 Natalizumab Natalizumab is used for the treatment of: Relapsing form of Multiple Sclerosis (MS) Adult Patients aged 18 years and over with the high disease activity despite treatment with a beta interferon or Glatiramer acetate. These patients may be defined as those who have failed to respond to a full and adequate course (normally at least one year of treatment) or beta interferon or Glatiramer IMP-027/2016 Interferon beta- 1a acetate. Interferon beta-1a is indicated for the treatment of: Ambulatory patients with relapsing multiple sclerosis characterized by at least 2 recurrent attacks of neurologic dysfunction (relapse) over the preceding 3 years period without evidence

5 of continuous progression between relapse. Interferon beta-1a slows the progression of disability and decreases the frequency of relapses. It is also indicated for the treatment of patients who have experienced a single demyelinating event with an active inflammatory process if it is severe enough to warrant treatment with intravenous corticosteroids, if alternative diagnosis have been excluded, and if they are determined to be at high risk of developing clinically definite multiple sclerosis. 14 M/s Baxalta Bioscience India IMP-054/2016 Coagulation factor IX (Rixubis) Coagulation Factor IX (Recombinant) is an antihemophilic factor indicated for: Control and prevention of bleeding episodes in adults and children with hemophilia B Perioperative management in adults and children with hemophilia B Routine Prophylaxis to

6 15 M/s UCB India 16 M/s Novartis Healthcare Pvt 17 M/s MSD pharmaceuticals IMP-57/2016 Peg-interferon beta-1a prevent or reduce the frequency of bleeding episodes in adults and children with hemophilia B Peg interferon beta-1a injection (Plegridy) is indicated in adult patients for the treatment of relapsing remitting multiple sclerosis IMP-059/2016 Ofatumumab Treatment of patients with progression of chronic lymphatic leukemia (CLL) after treatment with Fludarabine, Alemtruzumab and Rituximab, or patients for whom such combinations and other therapeutic alternative are ruled out. In combination with chlorambucil or bendamustine for treatment of patients with CLL who have not received prior therapy and who are not eligible for fludarabine based therapy IMP-093/2016 Pembrolizumab Indicated for the treatment of patient with unresectable and metastatic melanoma.