Lupin’s US unit will soon commence marketing the tablets used for the treatment of insomnia characterized by difficulties with sleep onset or sleep maintenance
Pharmaceutical company Lupin Ltd (Lupin), said it received a final approval for its Zolpidem Tartrate extended - release tablets USP 6.25mg and 12.5mg, from the US Food and Drugs Administration (FDA). Lupin’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 and is indicated for the treatment of insomnia characterized by difficulties with sleep onset or sleep maintenance.
Sanofi’s Ambien CR extended-release tablets had annual US sales of about $ 366 million as per IMS MAT March 2013 data.
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