Teva Pharmaceutical Industries received final FDA approval for medroxyprogesterone acetate injectable suspension USP in a 150 mg/mL pre-filled syringe. The pre-filled syringe is the generic equivalent of Pfizer's Depo-Provera, an injectable contraceptive. A launch date for the generic has not yet been finalized, according to the company.
Teva also was granted tentative approval for finasteride tablets USP in a 5 mg dosage. Final approval, however, is subject to the expiration of patent protection on June 19, 2006, and any exclusivity period following. Teva's finasteride tablets are the AB-rated generic equivalent of Merck's Proscar, indicated for improvement of symptoms of benign prostatic hyperplasia and reduction of risks of acute urinary retention and need for prostate surgery in patients with BPH.
Teva also was granted final approval for cefuroxime axetil tablets USP in 250 mg and 500 mg dosages. A launch date is planned for later this year. The drug is the AB-rated generic equivalent of GlaxoSmithKline's Ceftin, a broad-spectrum antibiotic with total annual sales, including brand and generic sales, of $102 million.
Finally, the company also received final approval for flumazenil injection in 0.1 mg/mL dosage. Flumazenil injection is the generic equivalent for HLR Technology's Romazicon Injection, a product used to reverse the sedative effects of benzodiazepines.
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