Wednesday, February 23, 2011

Aurobindo Pharma receives USFDA tentative approval

For Venlafaxine Extended Release Capsules

Aurobindo Pharma has announced overly the company has acquired tentative approval from the US Food & Drug Administration to manufacture and market Venlafaxine Hydrochloride Extended-release Capsules 37.5mg, 75mg and 150mg.

Venlafaxine Hydrochloride Extended-release Capsules 37.5mg, 75mg and 150mg are the generic equivalent of Wyeth Pharmaceuticals Inc's Effexor XR Capsules 37.5mg, 75mg and 150mg. Venlafaxine Hydrochloride Extended-release Capsules are showed for the care of drastic depressive disorder (MDD) and falls below the Neurological (CNS) therapeutic category. The product has a market size of something like US$ 2.4 Billion for the twelve cycles endingSeptember 2010 according to IMS.

The tentatively voted for ANDA No. 200834 for Venlafaxine Hydrochloride Extended-release Capsules 37.5mg, 75mg and 150mg was put forward with Paragraph IV certification and is by now short of litigation in the United States District Court for the District of New Jersey [Wyeth LLC v. Aurobindo Pharma Limited, and Aurobindo Pharma USA Inc., Civil Action No. 10-CV-02084]. The product willbe launched subsequent to the litigation settlement.

Aurobindo now has a total of 132 ANDA approvals (99 Final approvals and 33 Tentative approvals) out of USFDA.

The association assembled the current announcement on 24 February 2011.
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