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US FDA approves Wockhardt hypertension drug

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Wockhardt has received final approval from the US Food and Drug Administration ((FDA) to market extended-release tablets containing 2.5mg, 5mg and 10mg Felodipine, which are used to treat hypertension.

Felodipine is the generic name for the brand Plendil, marketed in the US by Astra Zeneca. Wockhardt is launching the product in the US immediately.

The total market for the product in the US was over $66m, according to IMS Health. Wockhardt founder chairman and group CEO Dr. Habil Khorakiwala said the company has received four ANDA approvals in the last five days and two of these are extended release pharmaceutical formulations.

“This definitely is a reflection of Wockhardt’s R&D prowess in indigenously developing such products,” Khorakiwala added.

Wockhardt will manufacture Felodipine API and Felodipine ER tablets in Ankleshwar and Aurangabad facilities, India, respectively.

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