Zydus Lifesciences bags USFDA nods for Dexamethasone Tablets USP, 0.5 mg, 0.75 mg, 1.5 mg, 4 mg and 6 mg and Dexamethasone Tablets USP, 2 mg
Ahmedabad: Zydus Lifesciences Limited has received final approvals from the United States Food and Drug Administration (USFDA) to manufacture and market Dexamethasone Tablets USP, 0.5 mg, 0.75 mg, 1.5 mg, 4 mg and 6 mg (USRLD: Decadron Tablets) and Dexamethasone Tablets USP, 2 mg (USRLD: Dexamethasone Tablets).
Dexamethasone is used to treat a number of different conditions, such as inflammation (swelling), severe allergies, adrenal problems, arthritis, asthma, blood or bone marrow problems, kidney problems, skin conditions, and flare-ups of multiple sclerosis.
The products will be manufactured at the group’s formulation manufacturing facility at Baddi, Himachal Pradesh.
Dexamethasone Tablets USP, 0.5 mg, 0.75 mg, 1.5 mg, 4 mg and 6 mg had annual sales of USD 22 mn and Dexamethasone Tablets USP, 2 mg has annual sales of USD 6 mn in the United States (IQVIA Dec. Nov. 2023).
The group now has 386 approvals and has so far filed over 448* ANDAs since the commencement of the filing process in FY 2003-04.
Medical Dialogues team had earlier reported that Zydus Lifesciences had received final approval from the USFDA for Clindamycin Phosphate Gel USP, 1% (USRLD: Cleocin T Gel, 1%).
Read also: Zydus bags USFDA nod for acne gel Clindamycin Phosphate
Formerly known as Cadila Healthcare Limited, Zydus Lifesciences Limited is an Indian multinational pharmaceutical company headquartered in Ahmedabad. The company is primarily engaged in the production of generic drugs. Cadila was founded in 1952 by Ramanbhai Patel.
