FDA shoots down pe­ti­tion to stall gener­ic ver­sions of Bris­tol My­er­s' block­buster chemo Abrax­ane

Five years af­ter Bris­tol My­ers Squibb’s Cel­gene filed a pe­ti­tion with the FDA as part of an at­tempt to de­lay the launch of gener­ic ver­sions of its block­buster chemo Abrax­ane, the agency has fi­nal­ly, and al­most com­plete­ly, re­ject­ed the pe­ti­tion.

Al­though Cel­gene in 2018 (pri­or to the Bris­tol My­ers’ ac­qui­si­tion) set­tled with Te­va’s Ac­tavis, al­low­ing at least one Abrax­ane gener­ic to en­ter the mar­ket on March 31, 2022, the com­pa­ny in 2015 sent over a pe­ti­tion to the FDA, seek­ing to add new re­quire­ments for any com­pa­nies look­ing to make copy­cats of its treat­ment for breast can­cer, NSCLC and pan­cre­at­ic can­cer, among oth­er can­cers.

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