Lupin gets tentative FDA nod for Pregabalin capsules

PTI Updated - July 07, 2011 at 02:54 PM.

Lupin has received tentative approval from the US health regulator to market Pregabalin capsules, used in the treatment of chronic pain as a result from an injury to the nervous system, in the American market.

The company’s US arm, Lupin Pharmaceuticals Inc, has received tentative approval from the US Food and Drug Administration (USFDA) for its Pregabalin capsules in strengths of 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg and 300 mg, Lupin Ltd said in a statement today.

Lupin’s Pregabalin capsules are the AB-rated generic equivalent of CP Pharmaceuticals’ Lyrica capsules, which are indicated for neuropathic pain associated with diabetic peripheral neuropathy, among other ailments.

According to IMS Health sales data, Lyrica capsules had annual US sales of nearly $1.7 billion for the 12 months ended March 31, 2011.

Meanwhile, the company shares were being quoted at Rs 461.20 apiece in the late afternoon trade on the Bombay Stock Exchange today, up 2.43 per cent from the previous close.

Published on July 7, 2011 09:24