Healthcare company Perrigo Company plc (NYSE:PRGO) (TASE:PRGO) said on Wednesday that its product development partner has received final approval from the US Food and Drug Administration (FDA) for its AB-rated Abbreviated New Drug Application (ANDA) of generic Metrogel-Vaginal Gel (metronidazole vaginal gel 0.75%).
Under a pre-existing arrangement with its partner, the company will acquire full ownership of the generic ANDA within 30 days and anticipates launching metronidazole vaginal gel 0.75% immediately thereafter.
In the 12 months ending May 2019, the annual market sales for MetroGel-Vaginal were approximately USD100m as measured by IQVIA.
The generic Metrogel-Vaginal Gel is manufactured and was developed through the company's partnership with Capstone Development Solutions, a company of Water Street Healthcare Partners, a strategic investor focused exclusively on the health care industry.
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