Zydus receives USFDA final approval for Bosentan Tablets & Trientine Hydrochloride Capsules

Zydus Cadila has received the final approval from the USFDA to market Bosentan Tablets USP (US RLD Tracleer Tablets), 62.5 mg and 125 mg and Trientine Hydrochloride Capsules USP (US RLD - Syprine Capsules), 250 mg. Both the products will be manufactured at the group's formulations manufacturing facility at SEZ, Ahmedabad.

Bosentan is used to treat high blood pressure in the lungs (pulmonary arterial hypertension). This condition is thought to be caused by increased levels of a certain natural substance (endothelinl). This medication blocks the effects of endothelin1, which helps lower blood pressure in the lungs, slow the worsening of symptoms from the disease and improves ability to exercise.

Trientine is a chelating agent. It works by removing a heavy metal (copper) from the blood. It is used to treat the Wilson's disease, a genetic metabolic defect that causes excess copper to build up in the body. Trientine is used to treat this inherited condition in people who cannot take penicillamine.

The group now has 265 approvals and has so far filed over 350 ANDAs since the commencement of the filing process in FY 2003-04.

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