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Latest From Par Pharmaceutical Inc.
Endo Slams FDA’s ‘Improper Rationalization’ In Adrenalin Rival’s ‘Unlawful Approval’
Endo’s Par subsidiary insists that long-existing statute for US patent infringement cases should hold off final approval for a supplemental rival to its Adrenalin treatment for anaphylaxis for several years – in contrast to the FDA granting a recent approval to BPI Labs.
Endo Offloads Manufacturing Site To Strides Pharma
Endo enters into an agreement with the subsidiaries of Strides Pharma to sell its manufacturing site in Chestnut Ridge, New York. Meanwhile, the company sees a double-digit drop in its generics business. Furthermore, Endo executes settlement resolving all opioid-related claims in Tennessee.
FDA Looks To Solve Chantix Shortage With Par ANDA Approval
Endo’s Par looks set to provide much needed supply in the US market for varenicline tablets, after originator Pfizer ran into supply and distribution problems due to the presence of a nitrosamine for its Chantix original.
Generic ‘Skinny Labels’ Get Reprieve As Court Agrees To Rehear Teva/GSK Case
Federal Circuit panel to reconsider whether Teva induced infringement of GSK Coreg patent despite label carve-out. Biologics and biosimilars could be particularly hurt if ruling stands given FDA’s recent guidance requiring reference to branded product.
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