Impax Laboratories, Inc., a specialty pharmaceutical company, announced that the US Food and Drug Administration (FDA) has approved its generic version of glyburide tablets 1.25 mg, 2.5 mg, and 5 mg. The company is preparing for commercialisation 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 officer 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), US brand and generic sales of glyburide tablets 1.25 mg, 2.5 mg, and 5 mg products were approximately $14 million for the 12 months ending in August 2015.