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Zydus Lifesciences Receives FDA Approval for Dexamethasone Tablets

Zydus Lifesciences Limited, along with its subsidiaries and affiliates, has recently obtained final approval from the United States Food and Drug Administration (USFDA) for the marketing of Dexamethasone Tablets USP, 1 mg. This medication, known as Dexamethasone Tablets in the US, is utilized in the treatment of various conditions including arthritis, blood/hormone disorders, allergic reactions, skin diseases, eye problems, breathing difficulties, bowel disorders, cancer, and immune system disorders.


The approved product will be manufactured at Zydus' formulation manufacturing facility located in Baddi, Himachal Pradesh. Dexamethasone Tablets USP, 1 mg, recorded annual sales of USD 1.8 million in the United States, according to data from IQVIA MAT March 24.

This approval marks another milestone for Zydus, bringing their total number of approvals to 395. Since the initiation of the filing process in the financial year 2003-04, Zydus has filed over 460 Abbreviated New Drug Applications (ANDAs), solidifying its position as a leading player in the pharmaceutical industry.


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