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Perrigo Receives Tentative FDA Approval of Generic Drug & Has Patent Challenged

By PR Newswire | August 23, 2016

Perrigo Company plc has received tentative approval from the U.S. 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 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 0.33 percent  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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Filed Under: Drug Discovery

 

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