1. Scrip
  2. >>New Products

Three Strikes For Generic Advair With An FDA CRL For Sandoz

 
• By Jessica Merrill

Novartis' generic drug unit confirmed the receipt of a complete response letter from the US FDA for a generic version of GlaxoSmithKline's Advair, following similar CRLs for Mylan and Hikma.

Baseball Pitcher Throwing ball, selective focus

Novartis AG's Sandoz Inc. generic drug unit will not be the first to market with a generic version of GlaxoSmithKline PLC's big asthma seller AdvairDiskus (fluticasone/salmeterol) – at least not for now. Several generic drug makers are vying for the lucrative prize of being first to the US market, but the first three applications to reach the FDA for review have each been met with a complete response letter.

Sandoz is the latest to receive a CRL from FDA, the company confirmed Feb. 8. The agency issued CRLs to...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Scrip 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 New Products

UroGen Gets A First-Ever Bladder Cancer Approval Despite US FDA AdComm ‘No’ Vote

 
• By Joseph Haas

UroGen’s Zusduri was approved despite an advisory committee vote recommending against it in May. It is the first approved drug for a type of recurring bladder cancer.

Nuvation Set For First Launch With Ibtrozi In Lung Cancer

 
• By Jessica Merrill

The US FDA approved taletrectinib for the treatment of ROS1+ NSCLC, where Nuvation hopes it will lead the category with a best-in-class position.

Pipeline Watch: ASCO Dominates Phase III Readouts

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

Santen Sees Potential In Myopia Market After Ryjunea Approval

 
• By Kevin Grogan

The low-dose atropine eye drop slowed the progression of pediatric myopia by 30%.

More from Scrip

AstraZeneca Taps Into China’s R&D Engine With CSPC Alliance

 
• By Andrew McConaghie

After in-licensing a cardiovascular candidate last year, AstraZeneca has signed a strategic drug discovery alliance, which could generate billions of dollars in payments to the Chinese firm.

Executives On The Move: New CMOs At Instil Bio, Nkarta & Catalyst Pharma

Recent moves in the industry include changes at the top at iOnctura and Orca Bio, plus Sutro Biopharma, Tenpoint Therapeutics and Helix BioPharma get new CFOs.

In Brief: Starton Moves Low-Dose Lenalidomide To Phase IIa For Multiple Myeloma

 
• By Sushmita Panda

Study to add to safety and tolerability data for infused formulation and may help identify optimal dose for future pivotal trial.