Perrigo (PRGO) Reports Tentative FDA Approval For Generic Suprep; Confirms Patent Challenge For Generic Version Of Mirvaso Gel

August 23, 2016 9:12 AM EDT

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Perrigo Company plc (NYSE: PRGO) today announced it has received tentative approval from the U.S. Food and Drug Administration ("FDA") for the generic version of Suprep® (sodium sulfate/potassium sulfate/magnesium sulfate) oral solution. The drug is indicated for the treatment of cleansing of the colon in preparation for colonoscopy in adults. Annual sales for the past 12 months ending July 2016 were $178 million.

Perrigo today also announced that it was sued by Galderma Laboratories, L.P. and Nestle Skin Health S.A. over the Company's Paragraph IV ANDA filing for the generic version of Mirvaso® (brimonidine) topical gel .33% which is indicated for the topical treatment of persistent (nontransient) erythema of rosacea in adults 18 years of age or older. Annual sales for the past 12 months ending July 2016 were $34 million.

Perrigo's CEO John T. Hendrickson stated, "These accomplishments demonstrate Perrigo's commitment to our customers and consumers around the world. The team's ability to develop and bring to market high quality, value alternatives in important treatment categories is what continues to drive Perrigo's mission of providing Quality Affordable Healthcare Products® around the world."

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