Zydus Lifesciences’ Diclofenac Sodium and Misoprostol Tablets gets FDA final approval

Zydus Lifesciences has secured final approval from the US Food and Drug Administration (FDA) to manufacture and market Diclofenac Sodium and Misoprostol Delayed Release Tablets USP, 50mg/200 mcg and 75mg/200 mcg.

The approval marks a significant step in expanding the company’s portfolio in the United States pharmaceutical market.

Diclofenac Sodium and Misoprostol tablets, generic for Arthrotec Delayed-Release Tablets, are used to treat osteoarthritis and rheumatoid arthritis in patients at high risk for developing stomach or intestinal ulcers.

Diclofenac belongs to the nonsteroidal anti-inflammatory drug (NSAID) group and works by reducing substances in the body that cause pain and inflammation. Misoprostol, on the other hand, decreases stomach acid and replaces stomach-protective substances reduced by NSAIDs, thereby protecting the lining of the esophagus, stomach, and intestines while the patient takes diclofenac.

Zydus Lifesciences gets FDA final approval for Diclofenac Sodium and Misoprostol Tablets. Photo courtesy of Zydus Cadila.

Diclofenac Sodium and Misoprostol, which recorded annual sales of $13 million in the United States (IQVIA MAT March 2023), will be produced at Zydus Lifesciences’ formulation manufacturing facility in Moraiya, Ahmedabad, India.

This approval raises the group’s total to 373 and expands on the 442 Abbreviated New Drug Applications (ANDAs) that the company has filed since it began the process in the fiscal year 2003-04.