FDA tentatively approves generic version of Suprep

Perrigo Company plc has received U.S. Food and Drug Administration (FDA) tentative approval for its generic formulation of Suprep, an oral solution of sodium sulfate, potassium sulfate and magnesium sulfate used to cleanse the colon when preparing for a colonoscopy.
 
Perrigo is also facing a patent challenge for its Paragraph IV ANDA filing for the generic for Mirvaso (brimonidine). The topical gel is used in treating persistent erythema of rosacea. Galderma Laboratories L.P. and Nestle Skin Health S.A. have filed the lawsuit to prevent Perrigo from developing and marketing the generic version of the medication.
 
"These accomplishments demonstrate Perrigo's commitment to our customers and consumers around the world," Perrigo CEO John T. Hendrickson said. "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 health care products around the world."
 
Headquartered in Ireland, Perrigo supplies affordable over the counter and generic prescription medications. 
 
In addition, Perrigo has developed the concept of over-the-counter drugs which are covered by prescription drug plans and dispensed by pharmacists. Generally, these medications were previously classed as prescription drugs, but have been reclassified by the FDA. Among the advantages of including over-the-counter medications in benefit plans are the lower drug costs and health plan costs. With a low- or no-copay for the medications, patients are more likely to follow their doctors' treatment plans.