Glenmark Pharmaceuticals Inc., USA (Glenmark) has received tentative approval by the US FDA for milnacipran hydrochloride tablets, 12.5 mg, 25 mg, 50 mg and 100 mg, the generic version of Savella tablets of Allergan Sales, LLC.
According to IMS Health sales data for the 12 month period ending February 2017, the Savella tablets, 12.5 mg, 25 mg, 50 mg and 100 mg market achieved annual sales of approximately $154.4 million.
Glenmark’s current portfolio consists of 113 products authorized for distribution in the US marketplace and 65 ANDA’s pending approval with the US FDA. In addition to these internal filings, Glenmark continues to identify and explore external development partnerships to supplement and accelerate the growth of its existing pipeline and portfolio.
Glenmark has a diverse pipeline with several compounds in various stages of clinical development primarily focused in the areas of oncology, respiratory disease, and dermatology. Glenmark’s current respiratory pipeline is aimed at addressing the global public health burden of allergic rhinitis, asthma, and COPD, and includes four investigational treatments across the disease spectrum and devices.
Glenmark pharma gets, us fda tentative approval, generic savella tablets
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