Zydus Lifesciences has received final approval from the USFDA (United States Food and Drug Administration) to manufacture and market its Arthritis drug Indomethacin suppositories 50mg.

The drug is a generic version of the reference-listed drug Indocin suppositories. The FDA has granted a Competitive Generic Therapy (CGT) designation and a 180-day CGT to exclusively market the drug.

Indomethacin suppositories is a non-steroidal, anti-inflammatory drug that is administered to moderate to severe rheumatoid arthritis that includes acute flares of chronic disease, mild to severe osteoarthritis, acute painful shoulder, moderate to severe ankylosing spondylitis, and acute gouty arthritis.

Sharvil Patel, Managing Director, Zydus Lifesciences Limited, said “We are happy to leverage the CGT approval pathway of the USFDA to provide patients with expanded access to a product with limited competition,”

The board of directors are set to meet on August 11 to consider the approval of unaudited results of the June quarter for the current fiscal year, apart from other agenda.

Prior to this, the company also received approval from the USFDA for Plerixafor on July 27.

At 1:50 pm, the share of Zydus Lifescience was trading at Rs 641.20 or 2.00% above its previous close on NSE.