Ranbaxy Laboratories has received final approval from the FDA to manufacture and market zolpidem tartrate tablets in 5mg and 10mg strengths.  The FDA has determined the Ranbaxy formulation to be bioequivalent and therapeutically equivalent to the reference listed drug Ambien manufactured by Sanofi Aventis. Zolpidem tartrate tablets are indicated for the short-term treatment of insomnia, characterized by difficulty with sleep intervention.

The product will be manufactured at the company's Ohm Laboratories facility, based in New Jersey. The drug has total annual market sales in the US of $2.12 billion according to IMS.

"This product will be launched immediately and presents yet another opportunity for Ranbaxy to expand its product portfolio by offering an affordable generic alternative for a molecule that has proven clinical value," said Jim Meehan, vice president of Sales and Marketing for Ranbaxy Pharmaceuticals.
 

Related Research

Pipeline Insight: Insomnia - Targeting the sleep maintenance market