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FDA Set To Make Key Decision On Restasis Generics

Akorn, Mylan And Teva Are In The Running For ANDA Approvals

 
• By Dean Rudge

Despite the door being opened for generic competition to Restasis more than a year, no FDA approvals for ANDAs referencing the eye-disease drug have been forthcoming. However, that could change before the year is out.

Yes or no decision
Restasis ANDA filers are eyeing an FDA decision by the year end • Source: Shutterstock

Akorn, Mylan and Teva have been tipped to receive “soon” US Food and Drug Administration approvals for the first generics of Allergan’s controversial Restasis (cyclosporine) 0.05% ophthalmic solution, with market entry possible by the end of 2020, Bernstein forecasts.

In 2019, a series of unfavorable legal rulings for the originator – which is now a part of AbbVie –...

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Regulatory Recap: FDA Starts ‘Radical Transparency’ Era After Publishing Over 200 CRLs

 
• By Urtė Fultinavičiūtė

Generics Bulletin reviews global regulatory developments across the world.