Medicure Inc., a Canadian specialty pharmaceutical company, announced that its majority-owned subsidiary, Apicore Inc., has received final approval from the U.S. Food and Drug Administration (FDA) for the company’s abbreviated new drug application for tetrabenazine tablets in the 12.5 mg and 25 mg strengths.
The newly approved product is a generic equivalent of the branded product Xenazine sold in the United States by Valeant Pharmaceuticals. Xenazine is indicated to treat the involuntary movements (chorea) of Huntington’s disease. Development of tetrabenazine was done in partnership with TAGI Pharma Inc., which recently launched the product commercially.
Medicure currently owns approximately 61 percent of Apicore on a fully diluted basis, and continues to have option rights until July 3, 2017 to acquire additional shares in Apicore.
Apicore is a private New Jersey-based developer and manufacturer of specialty Active Pharmaceutical Ingredients (APIs) and pharmaceuticals, including more than 15 Abbreviated New Drug Applications. The company has two FDA-approved facilities. Its Somerset, NJ, facility can produce a few grams up to 200 kg volumes; theVadodara, Gujarat facility in India can produce a few kilograms up to 60 metric tons yearly. Both facilities are equipped with analytical and research capabilities.
Medicure is a specialty pharmaceutical company focused on the development and commercialization of therapeutics for the U.S. hospital market. The primary focus of the company and its subsidiaries is the marketing and distribution of AGGRASTAT (tirofiban hydrochloride) in the United States, where it is sold through the its U.S. subsidiary, Medicure Pharma, Inc.
(Source: PR Newswire)