The reference listed drug (RLD) of Diclofenac Sodium and Misoprostol Delayed Release Tablets is Arthrotec Delayed-Release tablets and indicated to treat osteoarthritis and rheumatoid arthritis in people at high risk for developing stomach or intestinal ulcers. (For Representational purpose only)
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Zydus Lifesciences has received the U.S. Food and Drug Administration’s (U.S. FDA) final approval to manufacture and market Diclofenac Sodium and Misoprostol Delayed Release Tablets USP, 50mg/200 mcg and 75mg/200 mcg as well as Varenicline tablets 0.5 mg and 1 mg.
The reference listed drug (RLD) of Diclofenac Sodium and Misoprostol Delayed Release Tablets is Arthrotec Delayed-Release tablets and indicated to treat osteoarthritis and rheumatoid arthritis in people at high risk for developing stomach or intestinal ulcers. Zydus said the drug will be manufactured at the group’s formulation manufacturing facility in Ahmedabad. The product had annual sales of $13 million in the U.S., the company said, citing IQVIA MAT March 2023 figures.
On Varenicline tablets, it said the product is indicated to treat smoking addiction and will be manufactured at the group’s facility in Ahmedabad. The product, whose RLD is Chantix tablets, will be launched shortly. “This an important product which will support our growth plans in U.S. market in the current fiscal,” said managing director Sharvil Patel. Varenicline Tablets had annual sales of $501 million in the U.S., Zydus said citing IQVIA MAT March 2023 numbers.
In another development, the company said the group’s injectables manufacturing facility at Zydus Biotech Park in Changodar, Ahmedabad, underwent an inspection by U.S. FDA from June 5-13. The cGMP inspection concluded with nil observations, it said.