Elite Pharmaceuticals gets FDA approval for Phendimetrazine Tartrate tablets

NORTHVALE: Elite Pharmaceuticals announced that it has received approval of the Company’s abbreviated new drug application (ANDA) from the U.S. Food and Drug Administration (FDA) for Phendimetrazine Tartrate Tablets USP, 35 mg.

Based on recent Quintiles IMS Health data from March 2017, the retail sales for this product is approximately $4.5 million with three generic competitors. These sales numbers do not include most institutional sales or sales to clinics.

The Phendimetrazine Tartrate approval is from an Elite ANDA filed approximately six years ago. Since the filing, Elite obtained a second, approved Phendimetrazine Tartrate ANDA through Mikah Pharma.

Elite has been selling this generic product for more than five years. Elite is considering strategic options, including divestiture, for this newly approved ANDA.

“An ANDA approval for Phendimetrazine Tartrate at the end of 2017 was a welcome occurrence,” commented Nasrat Hakim, President, and CEO of Elite. “We look forward to additional approvals in 2018 from more recent filings.”