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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...

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Regeneron Wins Long-Sought FDA Nod For Lynozyfic In Myeloma

 
• By Alaric DeArment

The agency gave accelerated approval to the BCMAxCD3-directed bispecific antibody, which had been the subject of an August 2024 CRL.

Pipeline Watch: Eleven Approvals And ADA Readouts Dominate

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.

Empty Promises: Five Drugs That Fell Short Of Their Sales Forecasts

 
• By Edwin Elmhirst

Many assets underperform their pre-launch sales predictions, which can be disastrous to their developers and marketers. In this article, Scrip highlights several historic examples and the factors that influenced their poorer-than-expected performance.

Pipeline Watch: Ten Approvals And Seventeen 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.

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BerGenBio Plumps For Oncoinvent From Long List Of 50 Suitors

 
• By Kevin Grogan

The merger with a fellow Norwegian biotech comes a few months after its lead asset, bemcentinib, bit the dust.

In Brief: Opus Gears Up For FDA Filing In Presbyopia

 
• By Sushmita Panda

Data from a second pivotal trial support a filing in the US for Opus Genetics’ phentolamine ophthalmic solution, to treat presbyopia.

BlissBio Goes Solo On HER2-Targeting ADC After Eisai Exit

 
• By Dexter Jie Yan

BlissBio is to single-handedly move BB-1701, its eribulin-containing, HER2-targeting antibody-drug conjugate, into a global pivotal Phase II/III program for HER2-expressing, Enhertu-resistant breast cancer.