Actavis' Generic Version of Lamictal® ODT Receives FDA Approval

       Actavis' Generic Version of Lamictal® ODT Receives FDA Approval

PR Newswire

PARSIPPANY, N.J., July 15, 2013

PARSIPPANY, N.J., July 15, 2013 /PRNewswire/ --Actavis, Inc. (NYSE: ACT)
today announced that it has received approval from the U.S. Food and Drug
Administration (FDA) on its Abbreviated New Drug Application (ANDA) for
Lamotrigine Orally Disintegrating Tablets, 25 mg, 50 mg, 100 mg and 200 mg, a
generic equivalent to GlaxoSmithKline's Lamictal^® ODT. Actavis intends to
launch the product immediately.

As a "first applicant" to submit a substantially complete ANDA, Actavis may be
eligible for 180 days of generic market exclusivity. While the Company failed
to obtain tentative approval of its ANDA within 40 months after the date on
which it was filed, the FDA is not making a formal determination on Actavis'
eligibility for 180-day exclusivity at this time. It will do so only if
another paragraph IV applicant becomes eligible for full approval within 180
days after Actavis begins commercial marketing of its product.

Lamictal^® ODT is an antiepileptic drug indicated for the treatment of
epilepsy and bipolar disorder. For the 12 months ending May 31, 2013,
Lamictal^® ODT had total U.S. sales of approximately $51 million, according to
IMS Health data.

About Actavis

Actavis, Inc. (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 Parsippany, New
Jersey, USA.

Operating as Actavis Pharma, Actavis develops, manufactures and markets
generic, branded generic, legacy brands and Over-the-Counter (OTC) products in
more than 60 countries. Actavis Specialty Brands is Actavis' global branded
specialty pharmaceutical business focused in the Urology and Women's Health
therapeutic categories. 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
http://www.actavis.com.

Forward-Looking Statement

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 impact
of competitive products and pricing; risks related to third party patent
infringement claims or lawsuits; 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; 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 March 31, 2013 and Actavis' Annual
Report on Form 10-K for the year ended December 31, 2012. Except as expressly
required by law, Actavis disclaims any intent or obligation to update these
forward-looking statements.

Lamictal^® is a registered trademark of GlaxoSmithKline.

CONTACTS: Investors:
Lisa DeFrancesco
(862) 261-7152

Media:
Charlie Mayr
(862) 261-8030

(Logo: http://photos.prnewswire.com/prnh/20130124/NY47381LOGO )

SOURCE Actavis, Inc.

Website: http://www.actavis.com
 
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