1. Pink Sheet

Was Coronavirus A Factor In US FDA Approval Of Proventil HFA First Generic?

 
• By Derrick Gingery

The agency said Cipla’s ANDA met all the requirements for approval, but also that there is increased demand for the products.

FDA Approved typed words on a vintage typewriter
The US FDA's approval of the first generic of Proventil HFA came as there are worries about product shortages. • Source: Shutterstock

The US Food and Drug Administration suggested that its approval of the first generic version of Merck & Co. Inc.’s Proventil HFA (albuterol sulfate) metered dose inhaler may have at least some connection to the coronavirus outbreak.

Cipla Ltd.’s ANDA for the product, which is indicated for treatment or prevention of bronchospasm and exercise-induced bronchospasm, was...

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
Start Free Trial

Already a subscriber?

More from Generics

More from Biosimilars & Generics