Actavis Comments on Notification to Allergan, Inc. of Submission of
Application for Restasis®
DUBLIN, Jan. 22, 2014
DUBLIN, Jan. 22, 2014 /PRNewswire/ -- Actavis plc (NYSE: ACT) today confirmed
that its subsidiary, Watson Laboratories, Inc., has submitted an Abbreviated
New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA)
seeking approval to market a generic version of Allergan, Inc.'s 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.
Actavis plc (NYSE: ACT) is a global, integrated specialty pharmaceutical
company focused on developing, manufacturing and distributing generic, brand
and biosimilar products. Actavis has global headquarters in Dublin, Ireland
and U.S. administrative headquarters in Parsippany, New Jersey, USA.
Actavis Pharma markets generic, branded generic, legacy brands and
Over-the-Counter (OTC) products in more than 60 countries. Actavis Specialty
Brands is a global branded specialty pharmaceutical business focused
principally in the Urology and Women's Health therapeutic categories, as well
as Gastroenterology and Dermatology. Actavis Specialty Brands also has a
portfolio of five biosimilar products in development in Women's Health and
Oncology. Actavis Global Operations has more than 30 manufacturing and
distribution facilities around the world, and includes Anda, Inc., a U.S.
pharmaceutical product distributor.
For press release and other company information, visit Actavis' Web site at
Statements contained in this press release that refer to non-historical facts
are forward-looking statements that reflect Actavis' current perspective of
existing information as of the date of this release. It is important to note
that Actavis' goals and expectations are not predictions of actual
performance. Actual results may differ materially from Actavis' current
expectations depending upon a number of factors, risks and uncertainties
affecting Actavis' business. These factors include, among others, the
difficulty of predicting whether the FDA will accept Actavis' generic
Restasis® ANDA for filing or, if accepted by FDA, the date on which FDA will
deem the application filed; the difficulty of predicting the timing or outcome
of potential patent litigation concerning Actavis' ANDA for a generic version
of Restasis®; the impact of competitive products and pricing; the timing and
success of product launches; difficulties or delays in manufacturing; the
availability and pricing of third party sourced products and materials;
successful compliance with FDA and other governmental regulations applicable
to Actavis and its third party manufacturers' facilities, products and/or
businesses; the difficulty of predicting how the FDA will interpret applicable
Hatch Waxman rules related to Actavis' entitlement to marketing exclusivity
and the possibility that an adverse interpretation of such rules could
negatively affect Actavis' marketing exclusivity; changes in the laws and
regulations, including Medicare and Medicaid, affecting among other things,
pricing and reimbursement of pharmaceutical products; and such other risks and
uncertainties detailed in Actavis' periodic public filings with the Securities
and Exchange Commission, including but not limited to Actavis' quarterly
report on form 10-Q for the quarter ended September 30, 2013. Except as
expressly required by law, Actavis disclaims any intent or obligation to
update these forward-looking statements.
SOURCE Actavis plc
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