29.01.2016 10:15:18
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Dr. Reddy's Gets FDA Approval For Migraines Injection ZEMBRACESymTouch
(RTTNews) - Dr. Reddy's Laboratories Ltd. (RDY) announced Friday that the U.S. Food and Drug Administration or FDA has approved ZEMBRACESymTouch (sumatriptan succinate) injection for the acute treatment of migraines in adults.
It is 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.
ZEMBRACESymTouch will be marketed in the United States by Promius Pharma, a wholly-owned specialty company of Dr. Reddy's Laboratories.
Raghav Chari, Executive Vice President, Proprietary Products Group at Dr. Reddy's Laboratories, said, "ZEMBRACESymTouch is the first branded product in our Neurology portfolio. ... ZEMBRACESymTouch is specifically designed for patients who may experience certain migraine episodes and for whom a pill may not be the right option."
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