Drug Approval Standards

Critics of requirements that sponsors first demonstrate conventional labeling wouldn’t support an OTC switch before submitting proposals for ACNU switches and for simultaneous availability of Rx formulations of approved ACNU switches likely look to delay as chance to convince the agency to strike one or both components of the final rule.

Opella says FDA “lifted a clinical hold on its planned actual use trial to support the switch of Cialis” while Petros Pharmaceuticals shifts from working on its own ED-switch proposals to developing a proprietary technology-assisted platform designed for use in consumers’ self-selection of drugs made available in ACNU proposals.

Cavazzoni, who led the drugs center four-and-a-half years, decided on her own to retire at this time, sources said. The decision may have been a preemptive move knowing her time as head of CDER would have been limited, or at the very least highly challenging, under the new administration.

The injection for radicular leg pain appears likely to be approved, but with a very prescriptive label to help balance safety concerns and a lack of long-term outcomes data.

The drug maker announced positive topline Phase III results for its subcutaneous PD-1 inhibitor sasanlimab in first-line, BCG-naïve non-muscle invasive bladder cancer combined with BCG.

Final rule’s requirement that ACNU formulations also remain available as Rx generics could limit revenues for marketers of the nonprescription drugs while approvals of ACNU applications from studies with participants having drugs delivered to their homes may require marketers to limit distribution to direct-to-consumer without clearance for sales in retail stores.

Study completed in 2024 showed consumers using an online application accurately self-selected and safely used an Rx statin drug. An “ACNU” switch NDA would have to first show conventional OTC labeling won’t support proper self-selection and use.

Agency’s proposal for targeting making more formulations available nonprescription through “novel switches” went through changes on its path from idea in 2012 to proposed rule in 2022 and final rule published in December.

FDA’s ‘ACNU’ rule went through numerous twists and turns from agency’s “new paradigm” idea of OTC switches in 2012 to publication.