Reports: Drug makers may get approval for generic eye drug without clinical trials

FDA releases draft guidance on Allergan's Restasis

NEW YORK — Drug makers may be allowed to seek approval for a generic version of an eye drug made by Allergan based on lab tests rather than clinical trials, according to published reports.

In a draft guidance released Friday, the FDA said that due to the efficacy profile of Allergan's drug for dry eyes Restasis (cyclosporine) ophthalmic emulsion, it wouldn't be effective for companies to conduct clinical trials to determine the efficacy of a generic version.

According to reports, Allergan expects Restasis to have sales of up to $890 million this year. The FDA approved Restasis in December 2002, and its patent will expire in May 2014, according to FDA records.


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