US FDA Has 10 Months To Provide Answer On Perrigo/HRA OTC Oral Contraceptive Application
Perrigo's HRA Pharma submits to FDA on 11 July an NDA by for OTC 0.075-mg norgestrel, branded Opill, The same formulation previously was available Rx 30 years.
You may also be interested in...
The US FDA has scheduled a joint advisory committee meeting for November to review Perrigo subsidiary HRA Pharma’s new drug application for Rx-to-OTC switch of Opill (0.075-mg norgestrel), which would represent the first birth control pill available in the US without a prescription.
Perrigo delivered second-quarter results which CEO Murray Kessler described as “truly remarkable” as it lined up its oral contraceptive Opill (0.075-mg norgestrel) for OTC designation.
“I think the issue is whether it is going to have age restricted labeling, which would be a political issue rather than a medical issue,” says