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 The leading web portal for pharmacy resources, news, education and careers May 28, 2017
Pharmacy Choice - Pharmaceutical News - Abon Received Approval from the US FDA for Clofarabine Injection - May 28, 2017

Pharmacy News Article

 5/16/17 - Abon Received Approval from the US FDA for Clofarabine Injection

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 CLOLAR 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 CLOLAR 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 CLOLAR. "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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