The FDA has approved Novartis' osteoporosis drug Reclast for an expanded indication. Currently approved as a once-yearly infusion to treat post-menopausal osteoporosis, the drug will now also be marketed as a single treatment for use once every two years. The agency's decision is based on a study of over 500 women with low bone mass. Results from the study demonstrated that Reclast signicantly increased bone mineral density after two years, compared with the placebo. The drug is also approved to increase bone mass in male osteoporosis sufferers, for the treatment of osteoporosis caused by steroids and to treat Paget's disease.
GlaxosmithKline's Lamictal XR--an extended release version of its off-patent Lamictal--has been approved as an add-on therapy for patients 13 years and older with partial seizures. In a 19-week study, Lamictal significantly reduced frequency of seizures compared with the placebo. The drug will be available this summer, the company said in a statement. GSK hopes sales from Lamictal XR will replace the losses incurred when Lamictal went off-patent.
Finally, Glenmark Pharmaceuticals received FDA approval to market the generic version of Pliva's hydralazine hydrochloride tablets for hypertension. The company says it will start shipping the product immediately. According to IMS data, Pliva had over $55 million in sales March 2008 through March 2009 with limited competition, PharmaBiz reports.
- check out the Novartis release
- read GSK's statement
- here's the PharmaBiz article
ALSO: ARCA Biopharma was not so lucky. The company's shares plunged nearly 58 percent today on the news that the FDA issued a complete response letter for Gencaro (bucindolol hydrochloride) for the treatment of chronic heart failure. Report