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Pharmaceuticals / Submissions and Approvals

FDA Denies Allergan Petition for Higher Bar for Restasis Copies

Jan. 10, 2018
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The FDA denied a request from Allergan to reject any ANDAs referencing Restasis unless the applicant proves bioequivalence through clinical endpoints.

The petition was one of several measures by Allergan to safeguard its Restasis patents from potential competitors for its blockbuster eye medication, which pulled in $336.4 million in the second quarter of 2017.

In an August citizen petition, the drugmaker called on the agency to deny ANDAs for generics of  Restasis in the absence of the clinical data.

Allergan also asked the FDA not to approve any such ANDAs without waiting at least 60 days after issuing final guidance for cyclosporine ophthalmic emulsion testing.

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