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Lupin gets USFDA nod for insomnia drug

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

Press Trust of India  |  New Delhi 

major 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 Administration (USFDA) for its Zolpidem Tartrate Extended-release tablets in strengths of 6.25 mg and 12.5 mg, Ltd said in a statement.


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

The product of the Mumbai-based company is indicated for the treatment of 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 application (ANDA) filings with the stands at 177 with the company having received 86 approvals as of the quarter ended June 30, 2013.

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

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