Zydus Lifesciences bags USFDA nod for Indomethacin Suppository for rheumatoid arthritis

Ahmedabad: Zydus Lifesciences Limited has announced that the Company has received final approval from the United States Food and Drug Administration (USFDA) to manufacture and market Indomethacin suppositories, 50mg.

Zydus’ Indomethacin suppositories, 50 mg is the generic version of the Reference Listed Drug (RLD) Indocin suppositories.

Zydus has been granted a CGT designation by the USFDA for its Indomethacin suppositories. Zydus’ Indomethacin suppositories also been granted 180-day CGT exclusivity to market this product.

“We are happy to leverage the CGT approval pathway of the USFDA to provide patients with expanded access to a product with limited competition,” said Dr. Sharvil Patel, Managing Director, Zydus Lifesciences Limited. He further added, “The achievements of our team who have worked on the development, filing and manufacturing of Indomethacin suppositories reflects our ongoing commitment to bring complex generic products accessible to patients who need them the most.”

Read also: 

Indomethacin suppositories is a non-steroidal, anti-inflammatory drug indicated for moderate to severe rheumatoid arthritis including acute flares of chronic disease, moderate to severe ankylosing spondylitis, moderate to severe osteoarthritis, acute painful shoulder (bursitis and/or tendinitis) and acute gouty arthritis.

Indomethacin suppositories 50mg had an annual sales of approximately USD 95 mn in the United States (IQVIA MAT April-2023).

Read also: Zydus Lifesciences gets CDSCO panel nod to manufacture, market Relugolix Tablets

Medical Dialogues team had earlier reported that the Company had received final approval from the USFDA to manufacture and market Diclofenac Sodium and Misoprostol Delayed Release Tablets USP, 50mg/200 mcg and 75mg/200 mcg (USRLD: Arthrotec Delayed-Release Tablets).

Read also: Zydus Lifesciences wins USFDA nod for Diclofenac Sodium and Misoprostol Delayed Release Tablets

Zydus Lifesciences Limited, formerly known as Cadila Healthcare Limited, is an Indian Pharmaceutical company headquartered in Ahmedabad. The Company was founded in the year 1952 by Mr. Ramanbhai B. Patel (late), a first-generation entrepreneur and a doyen in the field of Indian Pharmaceuticals. It is primarily engaged in the manufacture of generic drugs.

Read also: Zydus Lifesciences concludes USFDA inspection at Ahmedabad facility with nil observations