1. Scrip
  2. >>Business

Cipla's Advair Generic US Debut May Be Pushed Out But 'Value Intact'

 
• By Anju Ghangurde

Cipla to pursue two-site, de-risked filing approach for large respiratory assets even as it awaits an FDA compliance classification for its Indore facility, which will determine the launch timelines for its much-awaited generic Advair in the US.

Investors Await Clarity On gAdvair Launch Timeline • Source: Shutterstock

Launch timelines for Cipla Limited’s long-awaited generic (g) Advair (salmeterol/fluticasone) in the US now hinge on whether its Indore site in India makes the compliance cut, but the firm claimed that even if things don’t go its way, the value proposition for the product remains unaltered.

The inspection classification of the Indore site by the US Food and Drug Administration was expected around mid-May and an unfavorable outcome could push the gAdvair launch timeline out by at least 12 months as

At the earnings call for the fourth quarter of fiscal 2023, Cipla’s global CEO and managing director Umang Vohra said that its gAdvair file is now solely dependent on the Indore facility

More from Business

More from Scrip

Novo Nordisk’s CEO Forced Out After Falling Behind In GLP-1 Battle

 
• By Andrew McConaghie

Company surprises investors with Jørgensen's exit but insists its strategy will not change.

In Brief: US FDA Delay Sends Biohaven Shares Down

 
• By Andrew McConaghie

The US regulator’s decision has taken Biohaven and investors by surprise, with the reason for a ‘major amendment’ status not clear.

Executives On The Move: Pathos Procures CEO From AstraZeneca, New CEO For TME Pharma, And More

Recent moves in the industry include changes at the top at Akamis Bio, Innospera Pharma & Ispen, plus Astellas Korea appoints an ex-Novartis Korea executive.