ALLEGAN, Mich., Feb. 12 Perrigo Company(Nasdaq: PRGO; TASE) today announced that it has received final approval fromthe U.S. Food and Drug Administration (FDA) for its Abbreviated New DrugApplication (ANDA) for over-the-counter Famotidine 10 mg, Calcium Carbonate800 mg, and Magnesium Hydroxide 165 mg, Chewable Tablets.
The product will be marketed under store brand labels and is comparable toJohnson & Johnson - Merck Consumer Pharmaceutical's Pepcid(R) Complete, anacid reducer plus antacid medication indicated for the relief of heartburnassociated with acid indigestion and sour stomach. Annual retail sales forPepcid Complete chewable tablets are estimated to be approximately $95million.
Perrigo's Chairman and CEO Joseph C. Papa concluded, "This final approvalreflects our continuing investment in new products. As always, Perrigo iscommitted to making quality healthcare more affordable for our customers anddrive value for our shareholders."
Perrigo was the first applicant to file a complete ANDA with a ParagraphIV certification and we expect to have marketing exclusivity. The Companyexpects to begin shipping the product in the third quarter of calendar 2008.
Perrigo Company is a leading global healthcare supplier that develops,manufactures and distributes over-the-counter (OTC) and prescriptionpharmaceuticals, nutritional products, active pharmaceutical ingredients (API)and consumer products. The Company is the world's largest manufacturer of OTCpharmaceutical products for the store brand market. The Company's primarymarkets and locations of manufacturing facilities are the United States,Israel, Mexico and the United Kingdom. Visit Perrigo on the Internet(http://www.perrigo.com).
Note: Certain statements in this press release are forward-lookingstatements within the meaning of Section 21E of the Securities Exchange Act of1934, as amended, and are subject to the safe harbor created thereby. Thesestatements relate to future events or the Company's future financialperformance and involve known and unknown risks, uncertainties and otherfactors that may cause the actual results, levels of activity, performance orachievements of the Company or its industry to be materially different fromthose 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 currentexpectations, assumptions, estimates and projections. While the Companybelieves these expectations, assumptions, estimates and projections arereasonable, such forward-looking statements are only predictions and involveknown and unknown risks and uncertainties, many of which are beyond theCompany's control. These and other important factors, including thosediscussed under "Risk Factors" in the Company's Form 10-K for the year endedJune 30, 2007, as well as the Company's subsequent filings with the Securitiesand Exchange Commission, may cause actual results, performance or achievementsto differ materially from those expressed or implied by these forward-lookingstatements. The forward-looking statements in this press release are madeonly as of the date hereof, and unless otherwise required by applicablesecurities laws, the Company disclaims any intention or obligation to updateor revise any forward-looking statements, whether as a result of newinformation, future events or otherwise.
SOURCE Perrigo Company