US FDA Launches OTC Monographs Online Portal
OTC Monographs@FDA is a publicly accessible repository for proposed, final, and interim final orders for OTC monograph drugs via the new OTC drug review program created by last year’s CARES Act. So far, the agency has posted seven of 32 “deemed” final orders created by the legislation.
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Authorization was a long time coming for FDA to reform OTC monograph program and streamline process to change formulations, indications or labeling for large majority of drugs available nonprescription. As program is overhauled, monograph updates may seem to be coming just as slowly.
As anticipated, the US FDA’s proposed order for sunscreens released on 24 September creates a bridge to the agency’s 2019 proposed rule before the CARES Act overhauled OTC drug review in March 2020.
PLx says Vazalore, only liquid-filled OTC aspirin in the US, had strong sales growth since launch in 30,000 stores. It plans second phase of rollout and promotions to expand outreach to cardiologists and patients.