The Food and Drug Administration (FDA) has given tentative approval for the generic version of Sernivo Spray 0.05% from Perrigo Company.
“Today's announcement marks our second tentative approval this year, in addition to four previously approved abbreviated new drug applications received in 2019,” said Sharon Kochan, Perrigo executive vice president and president Rx pharmaceuticals. “These approvals exemplify the talent and dedication of the entire Rx team and represent an impressive beginning to calendar year 2019.”
Perrigo provides over-the-counter health and wellness solutions so consumers can proactively prevent or treat conditions. The company prides itself on providing “Quality, Affordable Self-care Products.” From February 2018-February 2019, Perrigo’s annual market sales were approximately $15 million as measured by IQVIA.
The Hatch-Waxman litigation brought by Promius Pharma was previously settled with terms remaining confidential.
