The FDA has approved Ixempra (ixabepilone), a new anti-cancer treatment, for use in patients with metastatic or locally advanced breast cancer who have not responded to certain other cancer drugs. The FDA evaluated Ixempra under priority review, completing its assessment of the drug's safety and effectiveness in six months. Ixempra is administered by intravenous infusion. It is distributed by Bristol-Myers Squibb.
Sun Pharmaceutical said the FDA has approved its application to market its generic version of Novartis' Exelon (rivastigmine tartrate) capsules, used to treat mild to moderate dementia of Alzheimer's and Parkinson's disease. The India-based company said it shares a 180-day marketing exclusivity and in view of ongoing litigation with Novartis is evaluating launch options.
Novartis' Voltaren (diclofenac sodium topical gel) 1% received FDA approval as the first Rx topical treatment for pain associated with osteoarthritis.