FDA Changes Its Policy On Exclusivity For Fixed-Combination Products

In response to citizen petitions from Gilead, Ferring and Bayer, FDA issued a draft guidance saying future fixed-combination products that include a previously approved active moiety will be eligible for five years of new chemical entity marketing exclusivity.

Three companies convinced FDA to change its policy on the award of five-year market exclusivity to fixed-combination products, but they will not actually benefit from the shift since it will not apply to previously approved products.

FDA issued a draft guidance setting forth its new interpretation of provisions in the Hatch-Waxman Act that provide five-year exclusivity...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Archive

More from Pink Sheet