Actavis' Generic Opana® ER Receives FDA Approval

               Actavis' Generic Opana® ER Receives FDA Approval

PR Newswire

PARSIPPANY, N.J., July 12, 2013

PARSIPPANY, N.J., July 12, 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
Oxymorphone Hydrochloride Extended-release Tablets, 5 mg, 10 mg, 20 mg, 30 mg
and 40 mg.

Actavis' ANDA product is the generic equivalent to the previously marketed
formulation of Endo Health Solutions' Opana^® ER, which was voluntarily
withdrawn from sale in 2012.

Actavis previously received approval for, and is currently marketing,
Oxymorphone Hydrochloride Extended-release Tablets 7.5 mg and 15 mg. The
Company is currently defending ongoing patent litigation initiated by Endo
concerning the 7.5 mg and 15 mg Tablets, and is still evaluating launch plans
for the additional dosage strengths at this time.

Opana^® ER is an opioid agonist indicated for the relief of moderate to severe
pain in patients requiring continuous around-the-clock opioid treatment for an
extended period of time. For the 12 months ending May 31, 2013, Opana^® ER
tablets had total U.S. sales of approximately $461 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
difficulty of predicting the timing and outcome of the pending patent
litigation; 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; 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.

Opana^® is a registered trademark of Endo Pharmaceuticals, Inc.

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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