FDA approves Indocin oral suspension generic for inflammatory conditions
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Key takeaways:
- Indomethacin is a generic form of Indocin used to treat ankylosing spondylitis and other conditions.
- The drug’s annual U.S. market is estimated at $4.1 million, according to its manufacturer.
The FDA has approved an abbreviated new drug application from ANI Pharmaceuticals for indomethacin oral suspension, a generic version of Indocin oral suspension, according to a press release from the manufacturer.
In a statement, ANI Pharmaceuticals President and CEO Nikhil Lalwani said the approval comes with a competitive generic therapy designation (CGT) granting the company’s generic version of Indocin (Zyla Life Sciences) oral suspension 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,” Lalwani said in the release. “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.”
The approval comes after the FDA’s August 2023 acceptance of ANI’s estradiol gel, a generic form of Divigel (Vertical Pharmaceuticals).
Indomethacin is an NSAID approved by the FDA to treat ankylosing spondylitis, rheumatoid arthritis, osteoarthritis, gouty arthritis and other conditions. Estimates from IQVIA suggest the annual U.S. market for indomethacin oral suspension is currently about $4.1 million, according to the release from ANI Pharmaceuticals.
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