Abon Received Approval from the US FDA for Clofarabine Injection

Wednesday, May 17, 2017 Drug News
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NORTHVALE, N.J., May 16, 2017 /PRNewswire/ -- Abon Pharmaceuticals, LLC, a specialty pharmaceutical company, today announced

that it has received final approval from the FDA for its Abbreviated New Drug Application (ANDA) for Clofarabine Injection, 20 mg/20 mL, Single-use Vial. Clofarabine Injection is a generic equivalent of Genzyme's CLOLARŽ Injection, 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. According to IMS data, the sales for CLOLARŽ in 2016 were $67 M. Abon has entered into a distribution agreement with Fresenius Kabi USA to launch the product as First-to-Market generic for CLOLARŽ. "This product launch is a significant milestone for Abon" said Salah U. Ahmed, PhD President and CEO of Abon Pharmaceuticals, an independent privately owned LLC.

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 with high formulation barriers. Abon has filed multiple patent applications for drug delivery technologies. To date, six products developed at Abon, have been filed with FDA. This is the third FDA approval of product developed by Abon team and the first approval of an Abon ANDA product.

Contact: Salah Ahmed, 845-304-3493, salah.ahmed@abonpharma.com

To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/abon-received-approval-from-the-us-fda-for-clofarabine-injection-300458833.html

SOURCE Abon Pharmaceuticals, LLC



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