Zydus Lifesciences Obtains US FDA Approval for Dexamethasone Tablets USP, 1 mg

On May 11, 2024, Zydus Lifesciences Limited informed the stock exchanges that the company had got final approval from the United States Food and Drug Administration (US FDA) to market Dexamethasone Tablets USP, 1 mg.

Dexamethasone is used to treat a range of conditions, including arthritis, allergic reactions, skin diseases, blood/hormone disorders, breathing difficulties, bowel disorders, eye problems, cancer, and immune system disorders. The product will be manufactured at Zydus Lifesciences Limited’s formulation manufacturing facility in Baddi, Himachal Pradesh.

According to IQVIA MAT, on March 24, Dexamethasone Tablets USP, 1 mg, had annual sales of USD 1.8 million in the United States.

Zydus Lifesciences Limited stated that the group now has 395 approvals and has so far filed more than 460 (as of December 31, 2023) Abbreviated New Drug Application (ANDA) since the commencement of the filing process in FY 2003-04.

Earlier this month, the company announced that it had completed the enrollment of Phase 2b/3 EPICS IIITM trial of Saroglitazar Mg in patients with Primary Biliary Cholangitis (PBC). They added that the EPICS-IIITM Phase 2(b)/3 trial is led by Lead Principal Investigator Prof Raj Vuppalanchi. The late-stage clinical program with Saroglitazar Mg EPICS IIITM trial is now fully enrolled and will evaluate the effectiveness and safeness in patients with PBC who are uncontrolled on the usual first-line PBC treatment.

About Zydus Lifesciences Limited

Previously known as Cadila Healthcare Limited, Zydus Lifesciences Limited is a prominent Indian Pharmaceutical company and a fully integrated, global healthcare provider. The company has in-depth domain expertise in healthcare and strong abilities across the pharmaceutical value chain. From formulations to active pharmaceutical ingredients (API) and wellness products to animal healthcare products, Zydus has earned prominence amongst Indian pharmaceutical companies for offering a wide range of healthcare solutions.

On May 13, 2024, the share price of Zydus Lifesciences Limited opened at ₹991.20, touching the day’s low at ₹970.60, as of 10:55 AM on the NSE.

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