Taiwan TWi gains FDA approval for generic nifedipine

Generics/News | Posted 11/04/2014 post-comment0 Post your comment

Taiwan’s TWi Pharmaceuticals (TWi) announced on 7 April 2014 the approval of its abbreviated new drug application (ANDA) for generic nifedipine by the US Food and Drug Administration (FDA).

The drug is a generic version of Pfizer’s high blood pressure treatment Procardia XL (nifedipine). The generic nifedipine has been approved in 30 mg, 60 mg and 90 mg extended release tablets. TWi already started shipping the drug to its US distributor partner (Par Pharmaceutical Companies) at the end of January 2014 and plans to start marketing the product as soon as possible.

The drug is the first in the company’s pipeline to be approved in the US, according to TWi’s General Manager, Yeh Liru. China Chemical & Pharmaceutical, which sells drugs and medical equipment, is responsible for making the drug on a contract basis for TWi Pharmaceutical.

Procardia XL 30 mg, 60 mg and 90 mg, extended release tablets marketed by Pfizer and the generic equivalent drugs marketed by other companies, had annual sales in 2013 of approximately US$116 million in the US, according to IMS data.

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Source: Taipei Times, TWi

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