NORTHVALE, N.J., July 31, 2012 /PRNewswire/ -- Abon Pharmaceuticals, LLC, a specialty pharmaceutical company, today announced that it has filed an Abbreviated New Drug Application (ANDA), with a paragraph IV certification, with the U.S. Food and Drug Administration (FDA) seeking approval to market its Clofarabine Injection, 1 mg/ml. Abon's Clofarabine Injection is a generic equivalent of Genzyme's CLOLAR® Injection. CLOLAR® injection is a prescription medicine indicated for the treatment of pediatric patients 1 to 21 years old with relapsed or refractory acute lymphoblastic leukemia after at least two prior regimens.
Genzyme filed suit against Abon on July 27, 2012, in the United States District Court for the District of New Jersey seeking to prevent Abon from commercializing its product prior to the expiration of U.S. Patent No. 5,661,136.
Based on available information, Abon believes it may be the "first applicant" to file an ANDA for the generic version of CLOLAR® Injection and, should its ANDA be approved, may be entitled to 180 days of generic market exclusivity.
Total US sales for the twelve month period ending in June 2012 were approximately $77.5 million, according to IMS Health.
"This filing is an important milestone for Abon. It establishes our capability to expedite development of generic products facing significant barriers to entry," said Dr. Salah U. Ahmed, President, CEO and founder of Abon Pharmaceuticals, LLC. While several ANDAs for products developed by Abon have been filed with the FDA by its strategic partners, the Clofarabine Injection ANDA is the first to be filed and owned by Abon.
About Abon Pharmaceuticals, LLC
Abon Pharmaceuticals, LLC is a specialty pharmaceutical company that emphasizes science and technology in the development of generic and proprietary products that have challenging formulation barriers. Abon has filed multiple patent applications for drug delivery technologies. The founders and employees of Abon have extensive experience in the pharmaceutical field, with notable successes in developing and bringing many first entry generic products to market. Prior to founding Abon in 2009, Salah U. Ahmed, PhD, was the CSO and Executive VP of Global Research and Development at Barr Laboratories, Inc., and Bruce Downey Esq., another of the founders, was the Chairman of the Board and CEO of Barr Pharmaceuticals, Inc.
For press release and other company information, please visit Abon Pharmaceutical, LLCs' website at http://www.abonpharma.com.
SOURCE Abon Pharmaceuticals, LLC