Mumbai / Naples, Fla. (LabNews Media LLC) – Indian pharmaceutical company Lupin has launched generic Azilsartan Medoxomil tablets in strengths of 40 mg and 80 mg in the USA. The preparation is bioequivalent to the original product Edarbi from Azurity Pharmaceuticals and is approved for the treatment of high blood pressure in adults.
Lupin is eligible as the first-to-file applicant for this generic and will receive 180 days of market exclusivity. Approval was granted by the U.S. Food and Drug Administration (FDA) via an Abbreviated New Drug Application (ANDA).
With the launch, Lupin is expanding its portfolio in the area of cardiovascular generics in the USA. Azilsartan Medoxomil belongs to the group of angiotensin II receptor blockers (ARBs) and is used to lower blood pressure.
