ANI obtains FDA OK for generic Indocin

ANI has received the Food and Drug Administration’s approval for Indomethacin Oral Suspension, which is the generic of Indocin. 

Indomethacin is used to treat moderate to severe osteoarthritis, rheumatoid arthritis, gouty arthritis or ankylosing spondylitis. 

Indomethacin OS has a market value of approximately $4.1 million, per recent IQVIA data.

[Read more: ANI Pharmaceuticals receives ​​​​​​​FDA nod for generic Furadantin]

"With this approval, the FDA has granted Indomethacin OS a Competitive Generic Therapy  designation, with 180-day exclusivity. ANI continues to hold the second highest number of CGT approvals in the U.S. generics market, highlighting the strong capabilities and execution of our generics R&D team. We are happy to leverage the CGT pathway to provide our customers and patients in need with expanded access to high quality generics for limited competition products,” said Nikhil Lalwani, president and CEO of Ani.   

[Read more: ANI obtains FDA OK for generic Divigel]