Perrigo has received tentative approval from the U.S. Food and Drug Administration for the generic version of Sernivo® (betamethasone dipropionate) Spray 0.05%. Perrigo previously settled its Hatch-Waxman litigation relating to Sernivo® (betamethasone dipropionate) Spray 0.05% brought by Promius Pharma. Terms of the settlement remain confidential.
Annual market sales for the 12 months ending February 2019 were approximately $15 million as measured by IQVIA™.
"Today's announcement marks our second tentative approval this year, in addition to four previously approved abbreviated new drug applications received in 2019,” Perrigo Executive Vice President and President Rx Pharmaceuticals Sharon Kochan said. “These approvals exemplify the talent and dedication of the entire Rx team and represent an impressive beginning to calendar year 2019."
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