Zydus Cadila said it received final approval from the US Food and Drug Administration to market migraine drug Eletriptan Hydrobromide in the US.
The drug is currently marketed and manufactured by Pfizer Inc and sold in the US and Canada under the brand name Relpax.
The two key patents covering the drug are listed as scheduled for expiration on December 26, 2016, and August 29, 2017.
The drug which is used in the treatment of migraine, will be produced at the group’s formulations manufacturing facility at the Pharma SEZ in Ahmedabad.
The approval is for tablets of 20 mg and 40 mg dosage.
Eletriptan was approved by the U.S. in 2002 and is available only by prescription in the United States and Canada.
Zydus Cadila now has more than 120 approvals and has so far filed over 300 abbreviated new drug applications since the commencement of the filing process in FY 2003-04.
Eletriptan is believed to reduce swelling of the blood vessels surrounding the brain. This swelling is associated with the head pain of a migraine attack.
The drug blocks the release of substances from nerve endings that cause more pain and other symptoms like nausea, and sensitivity to light and sound.