1. Pink Sheet
  2. >>Biosimilars & Generics

US FDA Blocks 11 Viatris Products, Except Four With Shortage Concerns

 
• By Dean Rudge

Viatris’ oral finished dose manufacturing facility in Indore, India, was slapped with a US Food and Drug Administration import alert and warning letter.

Warning Letter
Four of the 11 products impacted by the import alert can still be imported because of shortage concerns. • Source: Shutterstock
Key Takeaways
  • The FDA issued an import alert to Viatris' Indore, India plant, blocking 11 products from entry into the US, although four products would be exempted due to shortage concerns.
  • The alert stemmed from a warning letter listing quality, data integrity and other problems.
  • Viatris said in a statement that corrective actions already are underway.

Eleven of Viatris’ products have been halted from entering the US after the firm’s oral finished dose manufacturing facility in Indore, India received a US Food and Drug Administration warning...

“There could be the potential for additional exceptions based on further discussions with the agency,” Viatris said in a statement, but did not provide details of the products with shortage...

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 Biosimilars & Generics

ICH Targets RWE, Rare Diseases, Biosimilars, ATMPs In New Guideline Push

 
• By Vibha Sharma

The International Council for Harmonisation has identified four new topics that can benefit from global regulatory alignment, with timelines for initiating work to be determined later.

US FDA Legislative Lead Calls For User Fee Reforms As Renewal Talks Near

 
• By Sarah Karlin-Smith

Deputy FDA Commissioner Grace Graham acknowledged the importance of user fees, while also calling for restructuring. She also said part of MAHA's mission is to reexamine uses of drugs not supported by data.

Pharma Industry Argues Tax, Other Incentives Better Than Tariffs

 
• By Jessica Merrill

Pharmaceutical industry organizations offered alternatives to tariffs that could maintain a secure domestic supply chain in public comments filed in response to a federal 232 investigation.

US FDA Guidance Roadblock: Writing Continues, But Publication Has Slowed Or Stopped

 
• By Derrick Gingery

Cuts to the FDA’s policy and legal personnel have prevented dozens of product-specific guidances for generic drug development from being published.

More from Compliance

US FDA Legislative Lead Calls For User Fee Reforms As Renewal Talks Near

 
• By Sarah Karlin-Smith

Deputy FDA Commissioner Grace Graham acknowledged the importance of user fees, while also calling for restructuring. She also said part of MAHA's mission is to reexamine uses of drugs not supported by data.

Industry Leaders Grapple With Trump’s Most Favored Nation Pricing Plan

 
• By Jessica Merrill

At the Bank of America health care conference, pharma leaders speculated on the impact of Trump’s most favored nation pricing executive order on US and European markets.

Mayne’s Nextstellis Promo Wrong To Suggest Better Safety Than Other Contraceptives, FDA Says

 
• By Sue Sutter

A professional slide deck for the drospirenone/estetrol oral contraceptive inappropriately suggests it is safer than other estrogen-containing products and understates risks, Office of Prescription Drug Promotion said in the first “untitled” letter issued since reductions-in-force.