Dr Reddy's gets FDA nod for 'Tosymra' migraine nasal spray

HYDERABAD: Dr Reddy's Laboratories Ltd Monday said US Food and Drug Administration has given approval for 'Tosymra' spray to treat acute migraine with or without aura in adults.

According to a statement issued by the drug maker, 'Tosymra' (previously known as DFN-02), is the latest product to join the Dr Reddy's US subsidiary Promius Pharma's acute migraine treatment portfolio.

The company is working toward commercialisation of this product.

"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 (healthcare professionals) treating them," Dr Reddy's Laboratories Co-Chairman and CEO, G V Prasad, said.

According to Promius Pharma, president, Anil Namboodiripad, 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.

Meanwhile, in a filing with BSE, the drug maker said the audit of its Active Pharmaceutical Ingredients (API) manufacturing plant at Miryalaguda in Telangana, by the US FDA, has been completed Monday with a Form 483 with one observation which is being addressed.