Zydus Gets Final USFDA Nod To Market Epilepsy And Menopause Drugs

Today the US Food and Drug Administration (USFDA) has given the firm final approval to market the Estradiol Transdermal System USP, 0.025 mg/day, 0.0375 mg/day, 0.05 mg/day, 0.075 mg/day, and 0.1 mg/day (USRLD: Vivelle-Dot® Transdermal System). The company said while making this announcement that Estradiol Transdermal System is indicated to treat moderate to severe symptoms of menopause which includes feelings of warmth in the face, neck and chest or sudden strong feelings of heat, hot flushes and vaginal dryness in women. The drug will be manufactured at the group’s formulation manufacturing facility at Moraiya, Ahmedabad, India. The organisation has filed over 431* ANDAs since the filing procedure began in FY 2003–04, and it now has 336 approvals.

The United States Food and Drug Administration (USFDA) granted Zydus Lifesciences Limited final permission yesterday, December 1st, to market Topiramate extended-release capsules, 25 mg, 50 mg, 100 mg, 150 mg, and 200 mg (USRLD: Qudexy® XR Extended-Release capsules). According to IQVIA statistics, topiramate Extended-Release capsule had yearly sales of USD 68.8 million in the United States (IQVIA MAT Sep 2022). The organisation has filed over 431* ANDAs since the filing procedure began in FY 2003–04, and it now has 335 approvals. The company said while making this announcement that Topiramate Extended-Release capsule is indicated to prevent and control seizures in people with epilepsy. It may also be used to prevent migraine headaches. The drug will be manufactured at the group’s formulation manufacturing facility at Ahmedabad SEZ, India.

On Tuesday, Zydus Lifesciences revealed that it has signed a business transfer agreement to acquire Watson Pharma's active pharmaceutical ingredients (API) business for a one-time payment of ₹46.77 crore, free of cash and debt. The acquisition is anticipated to be finished by March 31, 2023, and the Business Undertaking of Watson is in the business of producing, manufacturing, marketing, and selling Active Pharmaceutical Ingredients ("APIs").

The shares of Zydus Lifesciences opened today at ₹410.00 apiece and currently, it is trading at a market price of ₹411.05 with a downside gap of 0.06%. On a YTD basis, the stock has fallen 13.92% so far in 2022.