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FDA Approves Zembrace SymTouch

Dr. Reddy’s Laboratories Ltd. Receives FDA Approval for Zembrace SymTouch (sumatriptan succinate) Injection for the Acute Treatment of Migraines

HYDERABAD, India & PRINCETON, N.J.--(BUSINESS WIRE)--Dr. Reddy's Laboratories (BSE: 500124, NSE: DRREDDY, 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. 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.1

“We are pleased to have received FDA approval for Zembrace SymTouch,” said Raghav Chari, Executive Vice President, Proprietary Products Group at Dr. Reddy’s Laboratories. “Zembrace SymTouch 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. 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 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 G V Prasad, CEO and Co-Chairman, Dr. Reddy’s Laboratories.

1 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.

About Dr. Reddy’s

Dr. Reddy’s Laboratories Ltd. (NYSE: RDY) is an integrated pharmaceutical company, committed to providing affordable and innovative medicines for healthier lives. Through its three businesses – Pharmaceutical Services & Active Ingredients, Global Generics and Proprietary Products – Dr. Reddy’s offers a portfolio of products and services including APIs, custom pharmaceutical services, generics, biosimilars and differentiated formulations. Our major therapeutic areas of focus are gastro-intestinal, cardiovascular, diabetology, oncology, pain management and anti-infectives. Dr. Reddy’s operates in markets across the globe. Our major markets include – USA, Russia & CIS, Venezuela and India. For more information, log on to: www.drreddys.com.

Disclaimer: This press release may include statements of future expectations and other forward-looking statements that are based on the management’s current views and assumptions and involve known or unknown risks and uncertainties that could cause actual results, performance or events to differ materially from those expressed or implied in such statements. In addition to statements which are forward-looking by reason of context, the words "may," "will," "should," "expects," "plans," "intends," "anticipates," "believes," "estimates," "predicts," "potential," or "continue" and similar expressions identify forward-looking statements. Actual results, performance or events may differ materially from those in such statements due to without limitation, (i) general economic conditions such as performance of financial markets, credit defaults, currency exchange rates, interest rates, persistency levels and frequency/severity of insured loss events, (ii) mortality and morbidity levels and trends, (iii) changing levels of competition and general competitive factors, (iv) changes in laws and regulations and in the policies of central banks and/or governments, (v) the impact of acquisitions or reorganisation, including related integration issues.

Source: Dr. Reddy’s Laboratories Ltd.

Posted: January 2016

Zembrace SymTouch (sumatriptan) FDA Approval History

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