‘Storm Of Change’ Could Propel Industry On Making Daily Oral Contraceptive Available OTC In US
“It’s going to be industry people like me that have to make a decision that we're going to spend the time, we're going to spend the money to work with FDA for the many years it takes generally speaking to get these things approved,” says Femasys CEO Kathy Lee-Sepsick.
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FDA history with emergency contraceptives and opioid overdose antidote naloxone doesn’t assure Jeffrey Singer, Valley Surgical Clinics founder and advocate for making more drugs available OTC, the agency will approve HRA Pharma's NDA for OTC 0.075-mg norgestrel.
OTC drug development and marketing consultants discuss FDA allowing simultaneous Rx and OTC sales of same drug formulation with the same indication and about opportunities for follow-on generic equivalents of switches approved as additional condition for nonprescription use OTCs.
“Nonprescription Drug Product with an Additional Condition” for OTC use proposed rule would add to drug firms’ workloads for some OTC switches. Along with NDAs, sponsors would need to show a DFl isn’t sufficient to ensure a consumer can appropriately self-select and use a drug OTC and how an “additional condition” system would work.