Dr. Reddy’s receives USFDA nod for anti-migraine drug
Dr. Reddy’s Laboratories on Friday announced that it has received U.S. Food and Drug Administration (USFDA) approval for its ZEMBRACE SymTouch (sumatriptan succinate) injection. The drug-device combination product is intended for the treatment of acute migraine episodes, with or without aura, in adults who are inadequately managed with existing treatment regime. “ZEMBRACE SymTouch is available as a prefilled, ready to use, single-dose disposable autoinjector containing 3 mg of sumatriptan, a selective 5-HT1B/ID receptor agonist. The injection is intended to be given subcutaneously,” Dr. Reddy’s said in a statement. “We are pleased to have received FDA approval for ZEMBRACE SymTouch,” said Raghav Chari, Executive Vice President, Proprietary Products group at Dr. Reddy’s Laboratory. In many cases, migraine episodes are accompanied by severe nausea, making it difficult to swallow and retain pills. ZEMBRACE SymTouch is specifically designed for patients who may experience certain migraine episodes and for whom a pill may not be the right option. ZEMBRACE SymTouch will be marketed in the United States by Promius Pharma, a wholly-owned subsidiary of Dr. Reddy’s Laboratories. “This is a major milestone for the company as we continue to bring innovative medicines to patients and physicans,” said G V Prasad, CEO and Co-Chairman, Dr. Reddy’s Laboratories.
January 29, 2016 | 03:40pm IST
to success.