Dr. Reddy’s gets FDA nod for Tosymra

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Dr. Reddy’s gets FDA nod for Tosymra

By Sandra Levy - 01/28/2019
Dr. Reddy’s has gained approval for one of its branded offerings. The company and its subsidiary Promius Pharma have received the Food and Drug Administration’s clearance for Tosymra.

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

“We are excited about the approval of Tosymra. This approval affirms our ability to develop well differentiated products to meet the unmet needs of patients with migraine and HCPs treating them,” Dr. Reddy’s co-chairman and CEO G.V. Prasad said.

"Tosymra nasal spray 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. Independent research shows that 26%-to-40% of migraine patients are not optimally controlled with their current treatment. For patients who suffer from the debilitating and disruptive effects of migraine, there continues to be a need for reliable and efficacious treatment options,” Promius Pharma president Anil Namboodiripad said.

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