Eugia's Generic Clofarabine Receives Approval in the U.S.
Xospata leads latest CHMP recommendations
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) on Friday recommended the approval of three new medicines, including one orphan product, and recommended extending the indication for eight other drugs.
Ingenus Pharms' Generic Clofarabine Receives Approval in US
Enforcement Report - Week of November 22, 2017
Dr. Reddy s Laboratories Ltd today announced today that it has launched Clofarabine Injection, a therapeutic equivalent generic version of Clolar (clofarabine) Injection in the United States market, following the approval from the US Food and Drug Administration (USFDA).
Mylan N.V. (NASDAQ, TASE: MYL) today announced the U.S. launch of Clofarabine Injection, 20 mg/20 mL (1 mg/mL) Single-Dose Vials, a generic version of Genzyme's Clolar®. Mylan received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for this product, which is 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.
Amneal Pharm’s Generic Clofarabine Receives Approval In US
Mylan Lab’s Generic Clofarabine Receives Approval In US
Enforcement Report - Week of November 8, 2017