Teva announces approval of Fludarabine Phosphate Injection

JERUSALEM, ISRAEL, April 29, 2004 -- Teva Pharmaceutical Industries announced that the FDA has granted approval for an ANDA for Fludarabine Phosphate Injection, 25 mg/ml, which was submitted by the company's subsidiary Sicor Inc. Shipment of this product is expected to begin in the near future.

Sicor's Fludarabine Phosphate Injection, indicated for treatment of B-cell chronic lymphocytic leukemia, is substitutable for Berlex's Fludara for Injection.

Sicor was previously awarded marketing approval for a lyophilized formulation of this product in August 2003 and until now both the Sicor product and the brand product are a lyophilized formulation that requires reconstitution. Sicor's new approval is for a ready-to-use liquid for injection and it is expected that this new formulation will gradually replace the lyophilized formulation as it offers significant benefits for institutional users.
 
Source: Teva Pharmaceutical Industries

Posted: April 2004