1. Generics Bulletin
  2. >>Products
  3. >>Generics

FDA Guides On Rivals To Primatene Mist And Spiriva Respimat

Agency Releases Batch Of 34 Product-Specific Guidances

 
• By Dean Rudge

A batch of almost three dozen new and revised product-specific guidances for generic products has been published by the US Food and Drug Administration, including for rivals to Primatene Mist (epinephrine) metered-dose inhaler and Spiriva Respimat (tiotropium bromide) inhalation spray.

Washington, D.C., USA- January 13, 2020: FDA Sign outside their headquarters in Washington DC. The Food and Drug Administration (FDA or USFDA) is a federal agency of the USA.
the FDA recently awarded two universities in the US a five-year, $5m grant to establish a Center for Research on Complex Generics • Source: Shutterstock

The US Food and Drug Administration has released a batch of 13 new and 21 revised product-specific guidances for generics, including fresh guidance for abbreviated new drug application sponsors to develop versions of two complex inhalation aerosols: Primatene Mist (epinephrine) metered-dose inhaler; and Spiriva Respimat (tiotropium bromide) inhalation spray.

More from Generics

More from Products

J&J Denied Injunction Over Private-Label Ustekinumab In US

 
• By Dave Wallace

Stelara originator J&J has been denied in its initial attempt to prevent Samsung Bioepis and ustekinumab biosimilar partner Sandoz from selling a private-label version of the product through a PBM in the US.

UK Forxiga SPCs Wiped Out As Trio Succeed With Plausibility Attack

 
• By Dean Rudge

Generic competition to AstraZeneca’s blockbuster SGLT2 inhibitor Forxiga (dapagliflozin) treatment for diabetes may hit England and Wales earlier than 2028 after a pair of SPCs were invalidated following proceedings initiated by a trio of generics manufacturers.

What’s Next? Five Things To Look Out For In May

 
• By Dean Rudge

Generics Bulletin previews the most noteworthy and anticipated events for May 2025.