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Breckenridge Announces Final Approval of its ANDA for Imatinib Mesylate Tablets (RLD: Gleevec®)
BOCA RATON, Fla., March 4, 2019 /PRNewswire/ -- Breckenridge Pharmaceutical, Inc. announced that the U.S. Food and Drug Administration has granted final approval for its Abbreviated New Drug Application for Imatinib Mesylate Tablets, generic for Gleevec® Tablets by Novartis. Breckenridge's Imatinib Mesylate Tablets product was developed in collaboration with Stason Pharmaceuticals Inc. and will be commercially manufactured by Stason in 100mg and 400mg product strengths. Breckenridge plans to launch the product in the near future.
The product generated annual sales of approximately $654.8 million over the year ending December 31, 2018, according to industry sales data.
Breckenridge Pharmaceutical, Inc. is a privately held own-label distributor that performs pharmaceutical marketing, research and development, as well as marketing and distribution in the U.S. The company was founded in 1983 and markets a broad range of generic prescription products in many therapeutic categories. The Breckenridge label is recognized by wholesalers, distributors, chains, and managed care accounts, as well as retail pharmacies nationwide. The company markets over 70 products in a variety of dosage forms, including: tablets, capsules, liquids, suspensions, ophthalmics, nasal sprays, powders and injectable products.
With strong business ties to pharmaceutical interests in China, Japan, and Taiwan, Stason Pharmaceuticals, Inc., established in 1994 and based in Irvine, CA, is a privately held pharmaceutical company involved in drug development, manufacturing, importation and exportation, licensing and acquisition of both generic and branded products. The company's primary area of development is in the area of oncology, and supportive products for the treatment of side effects related to cancer therapy. Additional therapeutic areas include cardiovascular, central nervous system, autoimmune and endocrine disorders.
Gleevec® is a registered trademark of Novartis.
SOURCE Breckenridge Pharmaceutical, Inc.