1. Pink Sheet
  2. >>Biosimilars & Generics
  3. >>Generics

Mylan’s Generic Advair Delay Gives Leverage To Rivals

 
• By Jessica Merrill

Mylan received a “complete response” letter from FDA on its application for a generic version of GSK’s blockbuster Advair, offering scarce details on the reason why or possible length of the delay.

Mylan NV’s setback is GlaxoSmithKline PLC’s advantage. Mylan announced March 29 that it received a “complete response” letter from the US FDA relating to its ANDA to market a generic version of GlaxoSmithKline PLC’s asthma blockbuster Advair Diskus (fluticasone/salmeterol), likely delaying a launch by months and possibly longer.

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

US FDA Shows Support For Generic Drug User Fee Goals Amid Cutbacks

 
• By Michael McCaughan

The FDA struck an upbeat tone during its annual Generic Drugs Forum despite an unprecedented period of cutbacks and disruptions and reiterated a desire to continue meeting user fee goals.

Beyond Tariffs: The Silver Lining Of The US Pharma Security Investigation

 
• By Jessica Merrill

An investigation by the US Secretary of Commerce into pharmaceutical imports gives industry an opportunity to comment. AAM CEO John Murphy talked to Pink Sheet's sister publication Scrip about the latest developments.

US FDA Finds ‘Significant’ Data Integrity Breaches In CRO Raptim Studies

 
• By Urtė Fultinavičiūtė

The US FDA has deemed certain in vitro bioequivalence studies conducted by CRO Raptim Research “not acceptable” and raised concerns over its in vivo study methods.

Japan Pushes Generic Industry Reforms Via New Govt Fund

 
• By Lisa Takagi

Amid ongoing generic drug supply problems, Japan's government is to set up a new fund to support corporate investments geared towards manufacturing and consolidation.

More from Biosimilars & Generics

US FDA Finds ‘Significant’ Data Integrity Breaches In CRO Raptim Studies

 
• By Urtė Fultinavičiūtė

The US FDA has deemed certain in vitro bioequivalence studies conducted by CRO Raptim Research “not acceptable” and raised concerns over its in vivo study methods.

Missing BsUFA Revenue Trigger Could Open US FDA Staff To Criminal Penalty

 
• By Derrick Gingery

Massive layoffs and the biosimilar user fee program’s historic flirtation with the non-user fee spending requirements raise concerns that the FDA could lose its ability to collect BsUFA revenue, which could mean a fine or jail time for agency staff.

Biosimilars Industry Celebrates EMA’s Plan to Reduce Clinical Trials

 
• By Dave Wallace

The European Medicines Agency’s latest move towards a more streamlined process for biosimilar registration in Europe was the hottest topic at last week’s annual biosimilars conference held by Medicines for Europe in Amsterdam.