Duramed Pharmaceuticals, a subsidiary of Barr Pharmaceuticals, announced that the company has received two FDA approvals related to its Enjuvia (synthetic conjugated estrogens, B) product. The FDA has approved the company's supplemental New Drug Application for 0.9 mg tablet strength, which will be added to the company's existing Enjuvia product line that includes the 0.3 mg, 0.45 mg, 0.625 mg, and 1.25 mg tablet dosage strengths.
The FDA approved GlaxoSmithKline’s once-daily Veramyst (fluticasone furoate) Nasal Spray on Friday to treat seasonal and year-round allergy symptoms in adults and children two years of age and older. Veramyst will be available by prescription nationwide by late May 2007.
Sanofi-Aventis announced the FDA has approved Lantus SoloStar, a new prefilled disposable insulin pen for once-daily 24- hour insulin Lantus (insulin glargine) for the treatment of hyperglycemia in people with Type 1 or Type 2 diabetes. The Lantus SoloStar pen provides diabetes patients with an alternative to the traditional needle and syringe for insulin therapy.
The FDA has approved Janssen’s Invega (paliperidone) extended-release tablets, a new once-daily, atypical antipsychotic, for the long-term maintenance treatment of schizophrenia. Invega is now indicated for both acute (short-term) and maintenance (long-term) treatment of schizophrenia.