New Drug Approvals

DESVENLAFAXINE

read at

http://www.pharmaintellect.com/2013/03/alembic-gets-approval-for-extended.html?utm_source=feedburner&utm_medium=email&utm_campaign=Feed%3A+Pharmainvest+%28PharmaInvest%29

http://www.business-standard.com/article/companies/alembic-pharma-gets-us-nod-for-antidepressant-tablets-113030500304_1.html

5 march 2013

Alembic has announced that it has received an NDA approval for extended release version of  Pfizer’s anti depressant drug Pristiq. Pristiq sell approximately  $550m in the US. Alembic has outlicensed rights to  Ranbaxy for marketing in the US. The company will start marketing the product immediately.

Alembic will manufacture and supply the drug to Ranbaxy for marketing in the US. Vadodara-based pharma player, Alembic Pharmaceuticals Limited has received the approval from the US Food and Drug Administration (USFDA) for a bioequivalent version of Pristiq by Pfizer.

In a statement filed with the Bombay Stock Exchange (BSE) on Tuesday, Alembic informed that it has received USFDA approval for its new drug application (NDA), desvenlafaxine base extended release tablets.
The company is the sponsor and manufacturer of the NDA. Desvenlafaxine base extended release tablets is a prescription medicine and it is Alimbic’s first 505 (B) (2)…

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