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Dr. Reddy's Labs: FDA Approves TOSYMRA Nasal Spray For Migraine - Quick Facts

Dr. Reddy's Laboratories Ltd. (RDY,DRREDDY) and its subsidiary, Promius Pharma, LLC announced late Sunday the approval of TOSYMRA, previously known as DFN-02, by the U.S. Food and Drug Administration.

TOSYMRA is indicated for the acute treatment of migraine with or without aura in adults.

TOSYMRA is a mist-like nasal spray that acts rapidly and is well tolerated. It is formulated using a proprietary novel excipient known as Intravail to achieve blood levels similar to a 4-mg sumatriptan subcutaneous injection, resulting in rapid onset of action, the company noted.

TOSYMRA is the latest product to join the Promius Pharma acute migraine treatment portfolio. The company said it is working toward commercialization of this product.

G.V. Prasad, Co-Chairman and CEO, Dr. Reddy's, said, "This approval affirms our ability to develop well-differentiated products to meet the unmet needs of patients with migraine and HCPs treating them."

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