FDA gives tentative nod for Perrigo’s generic Sernivo spray
Perrigo has received tentative approval from the Food and Drug Administration for generic Sernivo spray (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.
The product had a market value of about $15 million for the 12 months ending February 2019, according to 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.
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.
The product had a market value of about $15 million for the 12 months ending February 2019, according to 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.