Indian pharmaceutical major Zydus Cadila has managed to receive the final approval from the US health regulator Food and Drug Administration (USFDA) to market Eletriptan Hydrobromide tablets (20 mg and 40 mg), which is used in the treatment of migraine.
Following the approval, the Indian drug maker will manufacture the migraine drug — which belongs to a class of drugs known as triptans — in its formulations unit located at the Pharma Special Economic Zone in Ahmedabad.
Manufactured by Pfizer Ireland under the brand name Relpax and available only on prescription, Eletriptan is widely used to help relieve headache, pain, and other symptoms of migraine and may allow the patient to return to their normal routine.
The side-effects of the medicine include narrowing of blood vessels in the brain and impact on certain nerves in the brain.
With USFDA nod, Zydus Cadila has now more than 120 approvals under its belt and has so far filed over 300 ANDAs since the commencement of the filing process by the company in FY 2003-04.