Actavis confirms challenge to Allergan's Restasis
Generics drug major Actavis (NYSE: ACT) has confirmed that its Watson Laboratories unit has submitted an Abbreviated New Drug Application with the US Food and Drug Administration for approval to market a generic version of Allergan’s (NYSE: AGN) ophthalmic drug Restasis(cyclosporine ophthalmic emulsion) 0.05% product.
The news caused Allergan’s shares drop as much as 4.5% to $115.58, before partially recovering to close the day’s trading down 1.3% at $118.52 yesterday.
Actavis' ANDA was submitted prior to the issue of FDA guidance related to approval of generic versions of Restasis products. Following issuance of guidance in June 2013, the FDA notified Actavis' subsidiary that it had refused to receive the ANDA for filing. Actavis disagrees with FDA's refusal to receive its ANDA for filing and remains in discussions with FDA concerning the filing status of its application.
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