Lupin's Generic Spiriva Launch Delayed As FDA Action Expected By August

Medisol Acquisition To Push Injectables Growth

12 May 2023

Lupin has pushed the launch for a generic to Boehringer’s blockbuster COPD drug Spiriva to September as FDA action is now expected “latest by August”. Meanwhile, an acquisition of Medisol in France and ANDA submissions in the US are part of an ongoing focus on injectables

FDA Approval Stamp — Lupin Awaits FDA Action On A Spiriva Generic • Source: Shutterstock

Lupin Limited is now hopeful of a September launch for its generic to Boehringer Ingelheim GmbH’s chronic obstructive pulmonary disease blockbuster drug Spiriva (tiotropium bromide) as it expects the US Food and Drug Administration (FDA)’s Target Action Date (TAD) latest by August.

The company had earlier received a Complete Response Letter (CRL) from the agency regarding its Abbreviated New Drug Application (ANDA) and has been responding to requests for information, delaying a...

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