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List of Approved Drug for Marketing in India in the
Year 2017

S. NO APPROVED DRUG INDICATION APPROVAL DATE
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. Sofosbuvir 400 mg film coated Tablet In combination with other medicinal products for the treatment of Chronic Hepatitis C (CHC) in adults With the condition: to be sold by retail on the prescription of Hepatologistonly 16.02.2017
9. Hydralazine tablets BP 25 mg (Additional Strength) For moderate to severe hypertension (in conjunction with a β-adrenoceptor blocking agent or diuretic) and hypertensive crisis. 23.02.2017
10.
Hydralazine tablets BP 50 mg
(Additional Strength)
For moderate to severe hypertension (in conjunction with a β-adrenoceptor blocking agent or diuretic) and hypertensive crisis. 23.02.2017
11. Bendamustine hydrochloride injection 90 mg/mL (Fill volume 0.5 mL in 2 ml capacity vial & 2 mL filled in 2 mL capacity vial
1. For the treatment of patients with chronic lymphocytic leukemia
2. For the use in Indolent B-cell Non-Hodgkin’s Lymphoma (NHL) that has Progressed During or Within six months of treatment with Rituximab or a Rituximab containing Regimen.
With the condition: to be sold by retail on the prescription of Oncologist/specialist only
02.03.2017
12.
Eltrombopagolamine 25 mg/50 mg tablets 
(Additional indication)
For the treatment of thrombocytopenia in paediatric patients 1 year and older with chronic immune(idiopathic) thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins or splenectomy. (It should be used only in patients with ITP whose degree of Thrombocytopenia and clinical condition increase the risk for bleeding. It should not be used in an attempt to normalize platelet counts). 02.03.2017

 

 

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