Abon Received Approval from FDA for Clofarabine Injection

Abon Pharmaceuticals announced 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.