Perrigo Announces FDA Approval Of The AB Rated Generic Version Of KlorCon® Extended-Release Tablets
DUBLIN, Nov. 10, 2015 /PRNewswire/ -- Perrigo Company plc (NYSE: PRGO; TASE) today announced it has received an AB therapeutic equivalent rating and final U.S. Food and Drug Administration ("FDA") approval for the generic version of KlorCon® extended-release tablets (600 mg and 750 mg), manufactured by Upsher-Smith Laboratories, Inc., and marketed by Sandoz Pharmaceuticals, Inc. The FDA concluded that Perrigo's product is therapeutically equivalent to KlorCon® extended-release tablets and can be substituted with the full expectation that it will produce the same clinical effect and safety profile as KlorCon® extended-release tablets when used under the conditions specified in the label.
KlorCon® extended-release tablets (potassium chloride) are indicated for the treatment and prevention of low levels of potassium in the bloodstream (hypokalemia). Combined generic and branded sales for the twelve months ending September 2015 were $81 million.
Perrigo's Chairman and CEO Joseph C. Papa stated, "This product approval, and launch in the next several weeks, demonstrates the growing strength of our Rx portfolio. The Rx team continues to gain important approvals in difficult product formulations. These approvals strengthen the Perrigo mission of providing Quality Affordable Healthcare Products® to our customers around the world."
Perrigo Company plc is a top five global over-the-counter ("OTC") consumer goods and leading specialty pharmaceutical company, offering patients and customers high- quality products at affordable prices. From the Company's beginning in 1887 as a packager of home remedies, it has grown to become the world's largest manufacturer of OTC healthcare products and supplier of infant formulas for the store brand market. The Company is also a leading provider of generic extended topical prescription products, and it receives royalties from sales of the multiple sclerosis drug Tysabri®. The Company provides "Quality Affordable Healthcare Products®" across a wide variety of product categories and geographies, primarily in North America, Europe and Australia, as well as in other markets, including Israel and China. Visit Perrigo online at (http://www.perrigo.com).
Certain statements in this presentation 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 Perrigo 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 presentation 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
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