New Delhi: Zydus Pharmaceuticals (USA) Inc has received tentative approval from the US health regulator to market pregabalin capsules, used for management of certain kinds of seizures, nerve pain, and fibromyalgia.
The company has got tentative approval from the US Food and Drug Administration (USFDA) to market the drug in the strengths of 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg and 300 mg, Zydus Cadila said in a BSE filing.
The drug will be produced at the group’s formulations manufacturing facility in Moraiya, Ahmedabad.
The Zydus group has more than 175 approvals and so far filed over 310 abbreviated new drug applications (ANDAs) since it started filings in 2003-04.
Zydus Pharmaceuticals Inc is a wholly-owned subsidiary of Cadila Healthcare Ltd.