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Impax Laboratories Inc.

Division of Amneal Pharmaceuticals LLC
www.impaxlabs.com

Latest From Impax Laboratories Inc.

Legal News: Teva V. FDA, Pay-For-Delay, Citizen Petitions, User Fee Scheme

US court tosses Teva suit seeking generic Restasis exclusivity. FTC loses appeal challenging Shire's citizen petitions, settles Solvay pay-for-delay case. DoJ resolves FCA case alleging company made deal to avoid paying FDA user fees for two NDAs.

Legal Issues Intellectual Property

Will Teva's Deal With FTC Change Future Patent Litigation Settlements?

Settlement reflects existing landscape in which companies are avoiding no-authorized generic commitments, and may harbinger FTC's shift to other issues.

Generic Drugs Legal Issues

Teva To Launch First Generic EpiPen In 'Coming Months'; FDA Heralds Approval Of Complex Product

Two-and-a-half years after receiving a complete response letter, Teva's ANDA clears FDA; agency issued three guidances for development of generic epinephrine auto-injectors.

BioPharmaceutical Regulation

Teva To Launch First Generic EpiPen In 'Coming Months'; FDA Heralds Approval Of Complex Product

Two-and-a-half years after receiving a complete response letter, Teva's ANDA clears FDA; agency issued three guidances for development of generic epinephrine auto-injectors.

BioPharmaceutical Regulation
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