The FDA approved AstraZeneca's Nexium (esomeprazole magnesium) for short-term use in children ages one -11 years for the treatment of gastroesophageal reflux disease (GERD). The agency approved Nexium in two forms, a delayed-release capsule and liquid form. Nexium is approved in 10 mg or 20 mg daily for children one -11 years old compared to 20 mg or 40 mg recommended for pediatric patients 12 to 17 years of age.
Sun Pharmaceutical Industries said the FDA has approved the company's abbreviated NDA to market its generic version of Hoffman la Roche's Demadex (torsemide) tablets indicated for treatment of edema associated with congestive heart failure, renal disease, or hepatic disease. These generic torsemide tablets include four strengths -- 5 mg, 10 mg, 20 mg and 100 mg. These strengths of Demadex have annual sales of approximately $35 million in the US, Sun said.
Barr Pharmaceuticals announced its subsidiary, Duramed Pharmaceuticals, has received FDA review of its NDA for Lo Seasonique (levonorgestrel/ethinyl estradiol tablets 0.10 mg/0.02 mg and ethinyl estradiol tablets 0.01 mg) extended-cycle oral contraceptive. The PDUFA date for Lo Seasonique is Oct. 24, 2008. The Lo Seasonique regimen is designed to reduce patient number of withdrawal bleeding periods from 13 to four per year.
ZARS Pharma said its Rapydan anesthetic patch (70 mg lidocaine/70 mg tetracaine medicated plaster) has received marketing authorization in Sweden, the UK, the Netherlands, France, Spain, Austria, the Czech Republic, Greece, Ireland, Norway and Portugal following the completion of the European mutual recognition procedure. ZARS Pharma has licensed the European sales and marketing rights of Rapydan to EUSA Pharma.