Actavis' Generic Suboxone Receives FDA Approval

Mon Feb 25, 2013 7:30am EST

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PARSIPPANY, N.J.,  Feb. 25, 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
Buprenorphine HCl and Naloxone HCl Dihydrate SL Tablets, 2 mg/0.5 mg and 8 mg/2
mg, the generic equivalent to Reckitt Benckiser Healthcare's Suboxone®.  

Actavis intends to begin shipping the product immediately.  Suboxone®  is
indicated for maintenance treatment of opioid dependence.   

For the 12 months ending  December 31, 2012, Suboxone®  tablets had total U.S.
sales of approximately  $625 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.  The Company has global and U.S. headquarters in 
Parsippany, New Jersey, USA, and international headquarters in Zug, Switzerland.

Actavis is the world's third-largest generics prescription drug manufacturer. 
Operating as Actavis Pharma, the Company develops, manufactures and markets
generic, branded generic, legacy brands and Over-the-Counter (OTC) products in
more than 60 countries.  The Company is ranked in the top 3 in 12 global
markets, the top 5 in 16 global markets, and in the top 10 in 33 global markets.
 Actavis Pharma also develops and out-licenses generic pharmaceutical products
outside the U.S. through its Medis third-party business, the world's largest
generic pharmaceutical out-licensing business. Medis has more than 300 customers
globally, and offers a broad portfolio of more than 200 products.   

Actavis Specialty Brands is the Company's global branded specialty
pharmaceutical business, which develops and markets a portfolio of approximately
40 products principally in  the United States  and  Canada  that are focused in
the Urology and Women's Health therapeutic categories.  Actavis Specialty Brands
is committed to developing and marketing biosimilars products in Women's Health,
Oncology and other therapeutic categories, and currently has a portfolio of 5
biosimilar products in development.  

Actavis Global Operations has more than 30 manufacturing and distribution
facilities around the world, with a capacity of approximately 44 billion units
annually.  Actavis Global Operations also includes Anda, Inc., the
fourth-largest U.S. generic pharmaceutical product distributor in  the United

For press release and other company information, visit Actavis' Web site at

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; 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  September 30, 2012  and Actavis' Annual Report on Form 10-K for
the year ended  December 31, 2011  (such periodic public filings having been
filed under the "Watson Pharmaceuticals, Inc." name).  Except as expressly
required by law, Actavis disclaims any intent or obligation to update these
forward-looking statements. Suboxone®  is a registered trademark of Reckitt
Benckiser Healthcare (UK) Ltd.

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

Charlie Mayr
(862) 261-8030

(Logo:  )

SOURCE  Actavis, Inc.

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