FDA Set To Make Key Decision On Restasis Generics

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

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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