Dr Reddy's gets USFDA nod for migraine injection

MUMBAI: Hyderabad based Dr Reddy's Laboratories On Friday announced that the U.S. Food and Drug Administration (FDA) has approved its new drug application (NDA) of ZEMBRACE injection, a drug-device combination intended for the treatment of acute migraine. The injection will be treated in adults who are inadequately managed with existing treatment regimens, the company said.

“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” said Raghav Chari, Executive Vice President, Proprietary Products Group at Dr. Reddy’s Laboratories. He further added that in many cases, migraine episodes are accompanied by severe nausea, making it difficult to swallow and retain pills. ZEMBRACESymTouch the company says is specifically designed for patients who may experience certain migraine episodes and for whom a pill may not be the right option.

The product will be marketed in the United States by Promius Pharma, a wholly-owned specialty company of Dr. Reddy’s Laboratories. Analysts have given a thumbs up for the product and are expecting sales worth $40-50 million.

Dr Reddy’s shares on Friday closed at Rs 3104 up by 3.21%