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Zydus Lifesciences' subsidiary, Zydus Worldwide DMCC has received the final approval from the USFDA for its Selexipag tablets. Additionally, it has also received 180-days of shared exclusivity for the same.

The approval for the Selexipag Tablets ranging between 200 mcg to as high as 1,600 mcg. Zydus was one of the first to submit a substantially complete Abbreviated New Drug Application (ANDA) with a paragraph IV certification for the Selexipag Tablet.

Selexipag is used for the treatment of pulmonary arterial hypertension (PAH), both to delay disease progression and reduce the risk of hospitalisation in adults. PAH is a type of high blood pressure in which blood vessels in the lungs are narrowed or blocked and it affects the arteries in the lungs.

The tablet is the therapeutic equivalent of US reference listed drug Uptravi, which is manufactured by Actelion Pharmaceuticals. Selexipag tablet had annual sales of $577 million in the United States as of September 30.

Earlier this month the Ahmedabad-based generic drugs maker had received final approval from USFDA to market Topiramate Extended-Release Capsules, 25 mg, 50 mg, 100 mg, 150 mg, and 200 mg, which is used to prevent and control seizures in epilepsy patients.

Zydus Lifesciences, formerly Cadila Healthcare, has a total of 338 approvals from the USFDA and has filed over 431 ANDAs as of September 30, 2022.

Shares of Zydus Lifesciences ended 0.4 percent higher at Rs 423.50.

Also Read: Zydus Lifesciences aims to build its specialty pharma business over the next five years