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Zydus Secures Final USFDA Approvals for Dexamethasone Tablets

Zydus Lifesciences Limited, along with its subsidiaries and affiliates, referred to as "Zydus," has recently garnered final nods from the United States Food and Drug Administration (USFDA) for the production and distribution of Dexamethasone Tablets USP in various strengths, including 0.5 mg, 0.75 mg, 1.5 mg, 4 mg, and 6 mg (known as Decadron® Tablets in the USRLD) as well as Dexamethasone Tablets USP, 2 mg (known as Dexamethasone Tablets in the USRLD).

Dexamethasone serves as a treatment for diverse medical conditions such as inflammation, severe allergies, adrenal issues, arthritis, asthma, blood or bone marrow disorders, kidney complications, skin ailments, and exacerbations of multiple sclerosis. These pharmaceuticals will be manufactured at Zydus' formulation manufacturing facility located in Baddi, Himachal Pradesh.

In the United States, Dexamethasone Tablets USP in strengths of 0.5 mg, 0.75 mg, 1.5 mg, 4 mg, and 6 mg boast annual sales of USD 22 million, while Dexamethasone Tablets USP in the 2 mg strength yield annual sales of USD 6 million, according to data from IQVIA Dec. Nov. 2023.

With this recent approval, Zydus now holds a total of 386 approvals and has submitted over 448 Abbreviated New Drug Applications (ANDAs) since the inception of the filing process in the fiscal year 2003-04.

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