Pharmaceutical major Dr Reddy’s Laboratories Ltd has announced that it has launched Clofarabine injection, which is used to treat acute lymphoblastic leukemia (a type of cancer of the white blood cells), in the United States market after getting approval from the US Food and Drug Administration (USFDA).
Clofarabine injection is a therapeutic equivalent generic version of Sanofi’s Clolar injection, which has sales of around $53 million in the US, according to IMS Health.
Dr. Reddy’s Laboratories’ Clofarabine injection is available in single-dose, 20 mL flint vials containing 20 mg of clofarabine in 20 mL of solution (1mg/mL).
Last month, the pharma major had to voluntarily recall over half a million Famotidine tablet bottles from the US market as the drug “failed impurities/degradation specifications”.
“Failed impurities/degradation specifications: Famotodine has an out of specification result for an individual related substance observed during routine stability testing of a batch for related substances -impurity 8 at 24 month stability interval,” the notification said on the reasons for recall.
The drug is used to treat and prevent ulcers in stomach and intestines.