Actavis And Perrigo Receive FDA Approval Of Guaifenesin/Pseudoephedrine, The Store Brand Equivalent To Mucinex® D Tablets
DUBLIN, June 2, 2015 /PRNewswire/ -- Actavis plc (NYSE: ACT) and its partner Perrigo Company plc (NYSE: PRGO; TASE) announced today that Actavis has received U.S. Food and Drug Administration approval for its Abbreviated New Drug Application (ANDA) for guaifenesin/pseudoephedrine tablets and that Perrigo will begin shipments in time for the cough/cold season to its retail and wholesale customers in the U.S. The product will be packaged and marketed under store and proprietary brands and will be a high quality, value alternative to Mucinex® D tablets.
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Mucinex® D (Guaifenesin/pseudoephedrine tablets), an expectorant indicated to relieve chest congestion and make coughs more productive, had sales of approximately $83 million through food, drug and mass merchandisers over the last 12 months.
Robert Stewart, Executive Vice President Actavis, and President, Generics and Global Operations stated, "We are pleased to partner with Perrigo to provide consumers with this high-quality, affordable treatment option. The FDA's approval of this complex product highlights the strength of Actavis' world-class generic R&D capabilities and underscores our commitment to continued innovation within our generics business."
Perrigo's Chairman and CEO Joseph C. Papa stated, "This approval is representative of the great partnership between Perrigo and Actavis, working together to get this difficult to manufacture and high priced product to the market. This is another excellent example of Perrigo's commitment to making quality healthcare more affordable for our customers."
About Actavis
Actavis plc (NYSE: ACT), headquartered in Dublin, Ireland, is a unique, global pharmaceutical company and a leader in a new industry model—Growth Pharma. Actavis is focused on developing, manufacturing and commercializing innovative branded pharmaceuticals, high-quality generic and over-the-counter medicines and biologic products for patients around the world.
Actavis markets a portfolio of best-in-class products that provide valuable treatments for the central nervous system, eye care, medical aesthetics, gastroenterology, women's health, urology, cardiovascular and anti-infective therapeutic categories, and operates the world's third-largest global generics business, providing patients around the globe with increased access to affordable, high-quality medicines. Actavis is an industry leader in research and development, with one of the broadest development pipelines in the pharmaceutical industry and a leading position in the submission of generic product applications globally.
With commercial operations in approximately 100 countries, Actavis is committed to working with physicians, healthcare providers and patients to deliver innovative and meaningful treatments that help people around the world live longer, healthier lives.
Actavis intends to adopt a new global name – Allergan – pending shareholder approval in 2015.
For more information, visit Actavis' website at www.actavis.com.
About Perrigo
Perrigo Company plc, a top five global over-the-counter (OTC) consumer goods and pharmaceutical company, offers consumers and customers high quality products at affordable prices. From its beginnings in 1887 as a packager of generic home remedies, Perrigo, headquartered in Ireland, has grown to become the world's largest manufacturer of OTC products and supplier of infant formulas for the store brand market. The Company is also a leading provider of branded OTC products, generic extended topical prescription products and receives royalties from Multiple Sclerosis drug Tysabri®. Perrigo provides "Quality Affordable Healthcare Products®" across a wide variety of product categories and geographies primarily in North America, Europe, and Australia, as well as other key markets including Israel and China. Visit Perrigo online at (http://www.perrigo.com).
Actavis Forward-Looking Statement
Statements contained in this press release that refer to future events or other non-historical facts are forward-looking statements that reflect Actavis' current perspective of existing trends and information as of the date of this release. Except as expressly required by law, Actavis disclaims any intent or obligation to update these forward-looking statements. Actual results may differ materially from Actavis' current expectations depending upon a number of factors affecting Actavis' business. These factors include, among others, the difficulty of predicting the timing or outcome of FDA approvals or actions, if any; the impact of competitive products and pricing; market acceptance of and continued demand for Actavis' products; risks associated with acquisitions, mergers and joint ventures; difficulties or delays in manufacturing; and 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, 2015. Except as expressly required by law, Actavis disclaims any intent or obligation to update these forward-looking statements.
Perrigo Forward Looking Statement
Note: Certain statements in this press release are forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and are subject to the safe harbor created thereby. These statements relate to future events or the Company's future financial performance and involve known and unknown risks, uncertainties and other factors that may cause the actual results, levels of activity, performance or achievements of the Company or its industry to be materially different from those expressed or implied by any forward-looking statements. In some cases, forward-looking statements can be identified by terminology such as "may," "will," "could," "would," "should," "expect," "plan," "anticipate," "intend," "believe," "estimate," "predict," "potential" or other comparable terminology. The Company has based these forward-looking statements on its current expectations, assumptions, estimates and projections. While the Company believes these expectations, assumptions, estimates and projections are reasonable, such forward-looking statements are only predictions and involve known and unknown risks and uncertainties, many of which are beyond the Company's control. These and other important factors, including those discussed under "Risk Factors" in the Company's Form 10-K for the year ended June 28, 2014, as well as the Company's subsequent filings with the Securities and Exchange Commission, may cause actual results, performance or achievements to differ materially from those expressed or implied by these forward-looking statements. The forward-looking statements in this press release are made only as of the date hereof, and unless otherwise required by applicable securities laws, the Company disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
ACTAVIS CONTACTS
Investors:
Lisa Defranceso
(862) 261-7152
Media:
David Belian
(862) 261-8141
PERRIGO CONTACTS
Arthur J. Shannon, Vice President, Investor Relations and Global Communications
(269) 686-1709
E-mail: [email protected]
Bradley Joseph, Director, Investor Relations and Global Communications
(269) 686-3373
E-mail: [email protected]
SOURCE Actavis plc
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