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)...
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