Zydus Lifesciences Ltd on Friday, February 16, announced that it has received the final approval from the United States Food and Drug Administration for Isosorbide Mononitrate Extended-Release tablets that are used to prevent chest pain in patients with heart problems.
Zydus Lifesciences has received the nod for the drug in USP strength of 30 mg, 60 mg, and 120 mg, the company said in a stock exchange filing. With the approval, the company will be able to manufacture and market Isosorbide Mononitrate Extended-Release Tablets in the US market.
According to IQVIA data, the drug had annual sales of $47 million in the United States in the 12 months to November 2023. Isosorbide mononitrate is used to prevent chest pain (angina) in patients with a certain heart condition such as coronary artery disease.
Zydus will manufacture the drug at its formulation facility at Ahmedabad SEZ, in Gujarat. With the latest approval, the number of approvals has gone to 388 so far and the group has filed over 460 ANDAs since FY 2003-04.
The company this month also received tentative approval from the US drug regulator to manufacture and market Dexamethasone Tablets USP, 1mg (USRLD Dexamethasone Tablets).
Dexamethasone is used to treat ailments such as arthritis, blood/hormone disorders, allergic reactions, skin diseases, eye problems, breathing problems, bowel disorders, cancer, and immune system disorders.
Zydus Lifesciences last month said that its wholly-owned subsidiary entered into an exclusive licensing and supply agreement with Synthon for Palbociclib Tablets for the US market.
Synthon will obtain US regulatory approval for the Palbociclib tablets and the manufacturing and supply of the drug.
Zydus Lifesciences shares ended 1.48% higher at ₹892 apiece, after scaling a 52-week high of ₹893.75 apiece earlier in the session.
(Edited by : Asmita Pant)
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