FDA approval for Impax Labs' generic version of Diabeta

5 October 2015

The US Food and Drug Administration has approved US generics drugmaker Impax Laboratories’ (Nasdaq: IPXL) generic version of diabetes drug glyburide, marketed as DiaBeta by France’s Sanofi (Euronext: SAN). The company is preparing for commercialization of this product through Impax's generic division.

"We are pleased to receive approval of generic glyburide tablets, a product that was developed at our Middlesex, NJ, facility," said Fred Wilkinson, president and chief executive of Impax. "Our diversified internal and external R&D network has delivered seven generic product approvals this year. With a pending Abbreviated New Drug Application pipeline of 30 products, we have multiple opportunities to further expand our commercialized portfolio."

According to IMS Health (NSP) quoted by Impax, US brand and generic sales of glyburide tablets products were around $14 million for the 12 months ending in August 2015.

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