Dr. Reddy's Laboratories (NYSE: RDY), announced today that the U.S. Food and Drug Administration (FDA) has approved ZEMBRACE™SymTouch™ (sumatriptan succinate) injection, a drug-device combination product intended for the treatment of acute migraine episodes, with or without aura, in adults who are inadequately managed with existing treatment regimens. ZEMBRACESymTouch 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. Safety and effectiveness in pediatric patients have not been established. ZEMBRACESymTouch injection is not recommended for use in patients younger than 18 years of age.
"We are pleased to have received FDA approval for ZEMBRACESymTouch," said Raghav Chari, Executive Vice President, Proprietary Products Group at Dr. Reddy's Laboratories. ZEMBRACESymTouch is the first branded product in our Neurology portfolio. Migraine affects millions of patients. Many of these patients have busy lives and quick pain relief is critical to help them manage through their daily routines. In many cases, migraine episodes are accompanied by severe nausea, making it difficult to swallow and retain pills. ZEMBRACESymTouch is specifically designed for patients who may experience certain migraine episodes and for whom a pill may not be the right option."
ZEMBRACESymTouch will be marketed in the United States by Promius Pharma, a wholly-owned specialty company of Dr. Reddy's Laboratories "This is a major milestone for the company as we continue to bring innovative medicines to patients and physicians," said Dr. Reddy's Laboratories CEO and CoChairman, G.V. Prasad.
Dr. Reddy's Laboratories Ltd.