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US Ambrisentan Approvals Hint At Different Commercial Approaches

Executive Summary

Four different firms have simultaneously received FDA approval for ambrisentan generics of Gilead’s Letairis. But different safety programs suggest Zydus Pharma may be taking a different commercial approach to the other three generics firms.

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Legislation on patent settlement agreements will not be retroactive; CREATES Act amended to give brand companies affirmative defense to litigation.

US releases guidance on REMS negotiation

Draft US guidance documents on developing a shared-system risk evaluation and mitigation strategy (REMS) and waivers for single shared-system REMS will “help generic drug makers get their products through the development and approval processes efficiently, while maintaining the safety controls”, according to US Food and Drug Administration (FDA) Commissioner Scott Gottlieb.

Industry peers among FDA access-denial list

Generics firms including Teva, Mylan, Sun’s Ranbaxy and Hikma’s Roxane are among almost 40 sponsors of reference drugs identified by the US Food and Drug Administration (FDA) on a list of “access inquiries” relating to difficulties experienced by generics firms in obtaining samples for development. Other companies named as sponsors of a reference listed drug (RLD) for which the FDA has received an access inquiry include originators such as AstraZeneca, Bayer, Boehringer Ingelheim, GlaxoSmithKline and Novartis.

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