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Green Light For First OTC Naloxone In US After FDA Raises Caution Flag During Advisory Panel

 
• By Malcolm Spicer

Sponsor Emergent revealed single-panel display of instructions at February advisory panel without testing in OTC human factors study. While different naloxone formulations and dosages will remain Rx-only, other Rx 4-mg nasal sprays, available through abbreviated NDAs as generics of Narcan, must transition to OTC, FDA says.

• Source: Shutterstock

A surprise sprung at an advisory panel meeting in February by the sponsor of an application for the first US OTC naloxone product didn’t knock the Food and Drug Administration off track as the agency met its deadline for a decision on the proposal.

The FDA and the proposal’s sponsor, Emergent BioSolutions, Inc., on 29 March separately announced the agency’s approval of the...

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More from Regulation

Pharma Deutschland Seeks To Enter Urban Wastewater Legal Dispute

 
• By David Ridley

The Urban Wastewater Treatment Directive “in its current form, is at an end,” insists Pharma Deutschland CEO Jörg Wieczorek. To put the directive to bed once and for all, the association has applied for leave to intervene in the ongoing EU legal battle in its own right.

Cloudy Tariff Conditions Expected To Linger In US

 
• By Malcolm Spicer

White House announces president extends deadline he set in April for other countries to make new tariff deals from July 9 to Aug. 1, when the administration will start sending letters warning other countries that higher tariffs could take effect.

FDA Takes World Tour In Recent OTC Warnings

 
• By Malcolm Spicer

FDA Center for Drug Evaluation and Research Office of Manufacturing Quality, Office of Compliance and Office of Unapproved Drugs & Labeling Compliance recently advise Indian, Canadian and US firms about GMP problems.

FDA’s FY 2026 Budget Request Lacks New Policy Proposals

 
• By Sue Sutter

The White House requested $6.8bn for the FDA, down 3.9% from the current funding level, but does not propose any legislative changes. In previous years, the agency used the budget process to seek statutory fixes specific to generic drugs and shortages.

More from Policy & Regulation

Over The Counter: How To Balance Access And Equity In Self-Care, With Bayer’s Emese Csoke

HBW Insight speaks to Bayer Consumer Health's global strategy director for regulatory, medical, safety, quality, and compliance Emese Csoke about how least how widening access to self-care solutions can be balanced with equity with regards to affordability.

US FDA’s Tough Talk On Talc: Regulating In An Echo Chamber

 
• By Michael McCaughan

An FDA “expert roundtable” on talc produced a new talking point on a potential drug safety risk, but the basis of that claim is difficult to determine.

Paying User Fees Not A Priority For Many OTC Monograph Drug Firms, First Arrears List Shows

 
• By Malcolm Spicer

The 1,383 entries on OMUFA arrears list for facility registrations from FY2021 through FY2025 on FDA’s list exceeds its estimate of 1,134 entities subject to the fee for FY2025.