Lupin has received final approval for its Zolpidem Tartrate Extended?release tablets USP, 6.25 mg and 12.5 mg from the United States Food and Drugs Administration (USFDA) to market a generic version of Sanofi Aventis, US, LLC’s (Sanofi) Ambien CR Extended?release tablets, 6.25 mg and 12.5 mg. The company’s wholly owned US subsidiary Lupin Pharmaceuticals Inc. (LPI) shall commence marketing the product shortly.
Lupin’s Zolpidem CR tablets 6.25 mg & 12.5 mg is the AB rated generic equivalent of Sanofi’s Ambien CR Extended?release tablets, 6.25 mg and 12.5 mg and is indicated for the treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenance.
Sanofi’s Ambien CR Extended?release tablets had annual US sales of approximately $366 million, as per IMS MAT March 2013.
