Breckenridge Wins ANDA for Azacitidine

The FDA approves the generic chemotherapeutic.

Breckenridge Pharmaceutical, Inc. announced on June 26th, that the FDA has granted approval of its (abbreviated new drug application (ANDA) for Azacitidine for injection —the generic version of Celgene’s anti-cancer chemotherapy Vidaza. The company said it submitted the ANDA with manufacturing partner Natco Pharma Limited.

Privately held, Breckenridge Pharmaceutical is an own-label distributor that performs research and development. The company also markets a broad range of generic prescription products in a variety of dose forms including tablets, capsules, soft gels, liquids and other popular types.

Vidaza is a prescription treatment anti-cancer chemotherapy specifically for myelodysplastic syndrome. In the 12-month period ending April 2017, the drug generated a combined sales total of $188 million.


Steve Kuehn

Steve offers the life science industry insight and perspective from his more than 30 years of editorial, corporate and agency communications experience. Drawing from tenure as a lead communicator and media relations director for one of world’s largest technology and engineering companies, as well the editorial leadership of industry-leading B2B journals serving the energy, transportation and pharmaceutical sectors, including Pharmaceutical Manufacturing magazine, Steve delivers brand strategy, market-moving content and decision support. Steve holds a Bachelor of Science degree from Ohio University.