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Teva Announces Approval Of Mitoxantrone Hydrochloride Injection USP |
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13 Apr 2006 |
JERUSALEM, Israel | Apr 12, 2006 | Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that the U.S. Food and Drug Administration has granted final approval for the Company’s ANDA for Mitoxantrone Hydrochloride Injection USP, 2 mg/mL. Shipment of this product will begin immediately.
Teva’s product is the AP-rated equivalent of Serono’s Novantrone® Injection, and is indicated for use in combination with corticosteroids as initial therapy for the treatment of patients with pain related to advanced hormone-refractory prostate cancer, and in combination with other approved products for the initial therapy of acute nonlymphocytic leukemia in adults.
Teva Pharmaceutical Industries Ltd., headquartered in Israel, is among the top 20 pharmaceutical companies in the world and is the leading generic pharmaceutical company. The company develops, manufactures and markets generic and innovative human pharmaceuticals and active pharmaceutical ingredients, as well as animal health pharmaceutical products. Close to 90% of Teva’s sales are in North America and Europe.
SOURCE: Teva Pharmaceutical Industries Ltd |
