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Actavis comments on notification to Allergan (AGN) submission

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mlkrborn   Wednesday, 01/22/14 01:08:50 PM
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Actavis comments on notification to Allergan (AGN) submission of application for Restasis; disagrees with FDA's refusal to receive its ANDA for filing and remains in discussions with FDA concerning the filing status of its application. (ACT) : Co confirmed that its subsidiary, Watson Laboratories, Inc., has submitted an Abbreviated New Drug Application (ANDA) with the FDA seeking approval to market a generic version of Allergan's (AGN) Restasis (cyclosporine ophthalmic emulsion) 0.05% product.

Actavis' ANDA was submitted prior to the issuance of FDA guidance related to approval of generic versions of Restasis products. Following issuance of FDA guidance in June 2013, 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.
On January 14, 2014, the U.S. Patent and Trademark Office issued a patent claiming a method of use related to Restasis. In accordance with applicable rules, Actavis' subsidiary amended its ANDA on that date to include a Paragraph IV certification to the newly issued patent and, in order to preserve its potential first-filer status, notified Allergan of its Paragraph IV certification. Actavis continues to work with the FDA to clarify the filing status of its ANDA.
Restasis is indicated to increase tear production in patients whose tear production is presumed to be suppressed due to ocular inflammation.

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