Unichem Laboratories receives US FDA approval for migraine drug

Unichem Laboratories Limited has received ANDA approval from the US Food and Drug Administration (FDA) for rizatriptan benzoate ODT 5 mg & 10 mg and rizatriptan benzoate tablets 5 mg & 10 mg. Rizatriptan benzoate ODT and rizatriptan benzoate tablets are therapeutically equivalent to Merck & Co’s Maxalt MLT tablets and Maxalt tablets, respectively. 

Rizatriptan benzoate is a serotonin (5-HT) 1B/1D receptor agonist (triptan) indicated for the acute treatment of migraine in adults and in paediatric patients 6 to 17 years of age.

The product will be commercialised from Unichem’s Goa plant. Active pharmaceutical ingredient (API) will also be made in house