Friday, 13 December 2013

Aurobindo Pharma receives USFDA approval for Duloxetine Hydrochloride Delayed Release Capsules

Aurobindo Pharma has received the final approval from the US Food & Drug Administration (USFDA) to manufacture and market Duloxetine Hydrochloride Delayed-Release Capsules 20mg (base), 30mg (base) and 60mg (base) which was earlier tentatively approved. According to IMS, the market size of the product is estimated to be $5.4 billion for the twelve months ending September 2013.

Duloxetine Hydrochloride Delayed-Release Capsules 20mg (base), 30mg (base) and 60mg (base) are the generic equivalent of Eli Lilly & Company’s Cymbalta Delayed-Release Capsules 20mg (base), 30mg (base) and 60mg (base). Duloxetine Hydrochloride Delayed-Release Capsules are indicated for the treatment of for the treatment of major depressive disorder (MDD) and falls under the Neurological (CNS) therapeutic category. The company now has a total of 188 ANDA approvals (163 Final approvals including 7 from Aurolife Pharma LLC and 25 Tentative approvals) from USFDA.

Aurobindo Pharma manufactures generic pharmaceuticals and active pharmaceutical ingredients. The company’s robust product portfolio is spread over 6 major therapeutic/product areas encompassing Antibiotics, Anti-Retrovirals, CVS, CNS, Gastroenterologicals, and Anti-Allergics, supported by an outstanding R&D set-up.

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