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

FDA To Use New Discipline Review Letters In Communicating ANDA Deficiencies To Generic Drugmakers

 
• By Joanne S. Eglovitch

FDA will be issuing discipline review letters and information request letters to generic drug applicants to communicate shortcomings in ANDAs. Under GDUFA II, the US agency agreed to send out these letters at the mid-point of the review clock.

FDA entrance sign 2016

FDA Dec. 15 issued draft guidance explaining its procedures for issuing discipline review letters (DRLs) to communicate deficiencies found in abbreviated new drug applications as well as information request (IR) letters where information is lacking.

FDA agreed under the Generic Drug User Fee Amendments of 2017 to sending out these letters midway through the first...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Generics Bulletin 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

Generic Drug Industry Seeks More US FDA Communication Reforms In GDUFA Renewal

 
• By Sue Sutter

Enhancing the consistency and clarity of information requests and discipline review letters, and improving assessment milestone communications are key areas targeted by generic drug makers for user fee program negotiations.

Danish Probe Could Influence Rethink Of Controversial EU Urban Wastewater Rules

 
• By Francesca Bruce

Some medicines may be subject to price rises that make them unaffordable if the burden of paying for extra wastewater treatment is not more fairly distributed across different industries, the Danish pharmaceutical industry association has warned.

Zydus Looks To Ride gIbrance Exclusivity Wave; GLP-1 Battle-Ready With Differentiated Pen

 
• By Vibha Ravi

Ibrance is losing share to other drugs, but Zydus looks forward to a late 2027/early 2028 launch of its generic in the US where partner Synthon might have 180-day exclusivity. In India, as Lilly launches Mounjaro KwikPen, it hopes for a GLP-1 edge with a differentiated device and formulation.

UPC Imposes Wide Cross-Border Injunction On Zentiva In Ofev Patent Clash

 
• By Dean Rudge

The UPC Court of Appeal has signaled that in pharma disputes, being ready to launch can be as risky as actually launching. In a major setback for Zentiva, the court ruled that completing certain steps well before patent expiry amounted to “setting the stage” for infringement.

More from Products

Henlius And Organon Sued In US Over Plans To Market Perjeta Biosimilar

 
• By Dean Rudge

Roche and its Genentech subsidiary have sued Shanghai Henlius Biotech and commercialization partner Organon in the US, alleging infringement of 24 patents covering Perjeta (pertuzumab). The litigation follows Roche’s recent disclosure that biosimilars to Perjeta could launch as soon as 2026.

Accord Takes On Ustekinumab Rivals In US With Steepest Discount Yet

 
• By Dave Wallace

Boasting the “lowest WAC price among branded biosimilars to Stelara”, Accord BioPharma has launched its Imuldosa version of ustekinumab in the US at a 92% discount to the blockbuster immunology brand.

Zydus Looks To Ride gIbrance Exclusivity Wave; GLP-1 Battle-Ready With Differentiated Pen

 
• By Vibha Ravi

Ibrance is losing share to other drugs, but Zydus looks forward to a late 2027/early 2028 launch of its generic in the US where partner Synthon might have 180-day exclusivity. In India, as Lilly launches Mounjaro KwikPen, it hopes for a GLP-1 edge with a differentiated device and formulation.