Perrigo Company plc issued the following announcement on July 3.
Perrigo Company plc (NYSE; TASE: PRGO) announced its product development partner received final approval from the U.S. Food and Drug Administration for its AB-rated Abbreviated New Drug Application ("ANDA") referencing Metrogel-Vaginal® (metronidazole vaginal gel 0.75%). Perrigo will acquire full ownership of the ANDA under a pre-existing arrangement with its partner within 30 days and anticipates launching this product immediately thereafter.
Annual market sales for MetroGel-Vaginal® for the 12 months ending May 2019 were approximately $100 million as measured by IQVIA™.
The product is manufactured by Perrigo and was developed through its partnership with Capstone Development Solutions, a company of Water Street Healthcare Partners, a strategic investor focused exclusively on the health care industry.
Perrigo Executive Vice President and President Rx Pharmaceuticals, Sharon Kochan stated, "This launch exemplifies Perrigo's commitment to developing and launching products within the extended topicals category. Our robust R&D pipeline remains focused on introducing more products that will create savings for patients and the U.S. healthcare system."
About Perrigo
Perrigo Company plc (NYSE;TASE: PRGO) is dedicated to making lives better by bringing "Quality, Affordable Self-care Products™" that consumers trust everywhere they are sold. The Company is a leading provider of over-the-counter health and wellness solutions that enhance individual well-being by empowering consumers to proactively prevent or treat conditions that can be self-managed. Visit Perrigo online at http://www.perrigo.com.
Original source can be found here.
