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Teva Pharmaceutical Industries Ltd. announced said late Wednesday that the US Food and Drug Administration has granted final approval for the company's generic drug treatment for patients with prostate cancer.
Mitoxantrone Hydrochloride injection USP, is used in combination with corticosteroids as an initial treatment for patients in pain from advanced hormone-refractory prostate cancer. It can also be used in combination with other products for the initial therapy for acute nonlymphocytic leukemia in adults.
Teva said it will immediately begin shipping the drug, which is the AP-rated equivalent of Serono's Novantrone Injection.
Separately, Teva said it expected to receive market exclusivity over the generic version of Pravachol, a cholesterol-lowering drug, next week after the FDA denied exclusivity to Canada's largest pharmaceuticals company Apotex, which requested 180-day exclusivity for pravastatin, the active ingredient in Pravachol.
In October 2005, the US District Court granted Teva's request to prevent the FDA administration from approving competing generic drug maker ANDA's generic Pravastatin Sodium Tablets 10 mg., 20 mg. and 40 mg., until the expiration of Teva's 180-day exclusivity.
The FDA concluded that it "interprets the court decision trigger provision to require a decision of a court that on its face evidences a holding on the merits of patent non-infringement, invalidity, or unenforceability. The July 23, 2004 Apotex-Bristol dismissal does not contain such a holding."
Teva expects final approval with exclusivity on April 20, when the product patent held by Bristol-Myers Squibb expires. Bristol-Myers' sales of Pravachol amounted to $2.6 billion. in 2004.