Mylan Pharmaceuticals Inc.
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Accelerated Approval Program web page links to searchable databases for accelerated approvals of infectious disease products, vaccines, and other nonmalignant indications. New databases, which include products that converted to regular approval or were withdrawn, are modeled after Oncology Center of Excellence’s cancer drug databases that debuted in 2021.
Zydus, along with Bristol Myers Squibb and generics companies like Mylan, Cipla and Dr. Reddy’s, has been named in an antitrust suit involving BMS’ blockbuster drug Revlimid. For now, it expects revenues from the generic to stretch beyond Q4 FY’23. Meanwhile, a recent acquisition of Watson, which made APIs for the Teva group, should shore up declining API revenues
Two acquisitions of brands in as many months, Lupin has stepped up its game in the Americas. A buyout of nine established Bausch Health brands follows rights to two from Sunovion. While it awaits news on generic(g) Spiriva, the launch of gPerforomist will help expand Lupin’s respiratory franchise
The latest accelerated approval withdrawals in the US are milestones for accountability in the program – most notably with the withdrawal of an antimicrobial with confirmatory studies more than a decade overdue.