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Purple Patch: US Approval For Cipla's Gx Albuterol, Staggered Supplies Planned

 
• By Anju Ghangurde

Cipla gets US FDA go-ahead earlier than anticipated for first generic of Merck’s Proventil, setting the stage for increased competition in the albuterol segment, where demand is up amid the coronavirus pandemic.

Cipla Gets US Go-Ahead For Key Respiratory Asset • Source: Shutterstock

Cipla Ltd. appears to have hit a purple patch in terms of forward momentum for its key respiratory assets in the US. After a milestone completion of Phase III studies for its rival version of GlaxoSmithKline PLC's Advair Diskus, the Indian firm has now received the go-ahead for the first generic of Merck Sharp & Dohme Ltd.’s Proventil HFA (albuterol sulfate) metered dose inhaler.

The final approval for Cipla’s ANDA for albuterol sulfate inhalation aerosol 90mcg (base)/actuation by the US Food and Drug Administration appears to have bested the company’s own relatively guarded outlook on timelines shared at the time of its third quarter fiscal year 2020 earnings. The Mumbai-headquartered firm indicated at the time that generic albuterol launch timelines may be pushed back a bit further from what it had earlier anticipated to the “latter half of the second half” of fiscal 2021, while it was “answering all the queries that the FDA is raising

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