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# FDA Approves Dr. Reddy’s Migraine Autoinjector
- URL: https://www.fdaweb.com/fda-approves-dr-reddys-migraine-autoinjector/
- Published: 2016-02-03T12:00:00.000Z
- Updated: 2026-09-15T02:33:07.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5134669

> FDA has approved a Dr. Reddy’s Laboratories NDA for Zembrace SymTouch (sumatriptan succinate) injection, a drug-device combination product (autoinjector) intended for treating acute migraine episodes, with or without aura, in adults who are inadequately managed with existing treatment regimens. The product is available as a prefilled, ready-to-use, single-dose disposable autoinjector containing 3 mg of sumatriptan, a selective 5-HT1B/ID receptor agonist. It is intended to be given subcutaneously.  
>  
> The company notes that Zembrace SymTouch’s safety and effectiveness in pediatric patients have not been established, and it is not recommended for use in patients younger than 18 years of age. It will be marketed in the U.S. by Promius Pharma, a Dr. Reddy’s wholly-owned specialty company.