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Jul 01, 2013
 |  BC Week In Review  |  Clinical News  |  Regulatory

Restasis cyclosporine regulatory update

FDA issued draft guidance for developing generic versions of Allergan's Restasis 0.05% cyclosporine ophthalmic emulsion that could lead to earlier than expected generic competition for the product. The agency recommended companies seeking an ANDA for the product conduct an in vitro study to determine the bioavailability or bioequivalence. The agency requested an in vivo bioequivalence...

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