DUBLIN, Nov. 24, 2014 /PRNewswire/ -- Perrigo Company plc (NYSE: PRGO; TASE) today announced that it has filed with the U.S. Food and Drug Administration (FDA) an Abbreviated New Drug Application for testosterone undecanoate injection and that it has notified the owner of the Reference Listed Drug of its filing.
On November 20, 2014, Endo Pharmaceuticals Solutions Inc., Bayer Intellectual Property GmbH and Bayer Pharma AG filed suit against Perrigo in the United States District Court for the District of Delaware, alleging patent infringement. This action formally initiates the process under the Hatch-Waxman Act. Perrigo confirms that it is a first filer for this opportunity, entitling it to 180 days of generic exclusivity.
Aveed® (testosterone undecanoate) injection is a schedule II controlled substance indicated for testosterone replacement therapy in adult males for the conditions associated with a deficiency or absence of endogenous testosterone of primary hypogonadism (congenital or acquired) or hypogonadotropic hypogonadism (congenital or acquired).
Perrigo's Chairman, President and CEO Joseph C. Papa stated, "This filing highlights our continued investment in bringing new products to market. Perrigo is committed to making quality healthcare more affordable for consumers around the world."
From its beginnings as a packager of generic home remedies in 1887, Perrigo Company plc, headquartered in Ireland, has grown to become a leading global healthcare supplier. Perrigo develops, manufactures and distributes over-the-counter (OTC) and generic prescription (Rx) pharmaceuticals, nutritional products and active pharmaceutical ingredients (API), and receives royalties from Multiple Sclerosis drug Tysabri®. The Company is the world's largest manufacturer of OTC healthcare products for the store brand market and an industry leader in pharmaceutical technologies. Perrigo's mission is to offer uncompromised "Quality Affordable Healthcare Products®" and it does so across a wide variety of product categories primarily in the United States, United Kingdom, Mexico, Israel and Australia, as well as more than 40 other key markets worldwide, including Canada, China and Latin America. Visit Perrigo on the Internet (http://www.perrigo.com).
Note: This press release includes certain "forward looking statements" within the meaning of, and subject to the safe harbor created by, Section 21E of the Securities Exchange Act of 1934, as amended, with respect to the business, strategy and plans of the Company, its expectations and its future financial condition and performance. Statements that are not historical facts, including statements about the Company's managements' beliefs and expectations, are forward looking statements. Words such as "may," "will," "could," "would," "should," "expect," "plan," "anticipate," "intend," "believe," "estimate," "predict," "potential" or the negative of those terms or other comparable terminology are intended to identify forward looking statements but are not the exclusive means of identifying such statements. 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. By their nature, forward looking statements involve risk and uncertainty because they relate to events and depend upon future circumstances that may or may not occur. Actual results may differ materially from the Company's current expectations depending upon a number of factors affecting the Company's business. These factors include, among others, the inherent uncertainty associated with financial projections; successful completion of the transactions contemplated herein; the risks and uncertainties normally incident to the pharmaceutical industry, including product liability claims and the availability of product liability insurance; market acceptance of and continued demand for the Company's products; changes in tax laws or interpretations that could increase the Company's tax liabilities; and such other risks and uncertainties detailed in the Company's periodic public filings with the SEC, including but not limited to those discussed under "Risk Factors" in the Company's Form 10-K for the fiscal year ended June 28, 2014, in the subsequent filings with the SEC and in other investor communications of the Company from time to time. The forward-looking statements in this document 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.
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SOURCE Perrigo Company plc