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.