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Adverse Events For Generic Of GSK's Advair Diskus On US FDA’s Radar

 
• By Derrick Gingery

As patients log device complaints for Mylan’s Advair Diskus generic Wixela Inhub, the agency is assessing whether additional reminders about the products’ differences are needed.

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The FDA Office of Generic Drugs does not want differences between complex generics and their reference products to hinder generic uptake. • Source: Shutterstock

The US Food and Drug Administration sees proactive surveillance of complex generics as a chance to avoid patient rejection of first generics in addition to monitor for any potential safety problems.

Among the first test cases is the launch of Mylan NV’s Wixela Inhub (fluticasone propionate/salmeterol), the first generic of...

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More from Biosimilars & Generics

Repurposed Drugs: EU Pharma Reform Offers Boost, But Payers ‘Must Recognize Health Gains’

 
• By Eliza Slawther

Incentives for repurposed drugs proposed as part of the EU pharma reform package are a “great step forward,” but more recognition is needed from payers and regulators to leverage the benefits of these medicines, experts say.

Canada Joins Global Push To Drop Costly Clinical Trials For Biosimilars

 
• By Neena Brizmohun

Health Canada’s proposal to no longer require biosimilar manufacturers to prove the safety and efficacy of their product through Phase III clinical trials marks a pivotal change in Canada’s regulatory approach.

Lupin Concedes To Harmony On Generic Wakix With 2030 Launch Agreement

 
• By Dean Rudge

Lupin became the latest ANDA sponsor to settle patent-infringement litigation over Harmony Biosciences’ Wakix (pitolisant hydrochloride), which has been touted as a potential blockbuster.