Lupin gets USFDA nod for insomnia drug

The company has received final approval for its Zolpidem Tartrate Extended-release tablets

Drug major Lupin today said it has received US health regulator's approval to market a generic version of Sanofi Aventis' Ambien CR Extended-release tablets, used in treating sleep disorders, in the American market.

The company has received final approval from the US Food and Drug Administration (USFDA) for its Zolpidem Tartrate Extended-release tablets in strengths of 6.25 mg and 12.5 mg, Lupin Ltd said in a statement.

"Lupin's wholly-owned US subsidiary Lupin Pharmaceuticals Inc shall commence marketing the product shortly," it added.

The product of the Mumbai-based company is indicated for the treatment of insomnia characterised by difficulties with sleep onset or sleep maintenance.

As per the IMS MAT March 2013 sales data, Sanofi's Ambien CR Extended-release tablets had annual US sales of nearly USD 366 million.

Lupin's cumulative abbreviated new drug application (ANDA) filings with the USFDA stands at 177 with the company having received 86 approvals as of the quarter ended June 30, 2013.

Shares of Lupin today closed down by 2.67% at Rs 838.40 on the BSE.