FDA Moves On NDA For First US OTC Birth Control, Scheduling Joint Ad Comm Meeting
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.
You may also be interested in...
“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
HRA didn't have time to incorporate into its switch NDA instructions stated in proposed ACNU rule published in June, but the firm, which worked with Ibis Reproductive Health on proposal, had time to plumb a draft guidance FDA published in 2018 on novel switches.
Along with Q2 results including reported net sales up 14.3% to $1.12bn, Perrigo announces overhaul of its supply chain expected to generate $100m to $300m in net cost savings and creation of women's health, skin care business units.