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
Source: Teva Pharmaceutical Industries
Posted: April 2004