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US OTC Birth Control NDA Could Debut ‘Additional Conditions for Nonprescription Use’ Labeling

 
• By Malcolm Spicer

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ACNU rule published in June, but the firm, which worked with Ibis Reproductive Health on proposal, had time to plumb a draft guidance FDA published in 2018 on novel switches.

• Source: Shutterstock

A move US regulators acknowledged as a departure from the norm in their processes – publishing guidance before a rule – likely helped HRA Pharma prepare its new drug application for an OTC daily oral contraceptive.

The Perrigo Company PLC business submitted to the Food and Drug Administration its switch NDA for 0.075-mg norgestrel branded...

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More from Rx-to-OTC Switch

EU Pharma Reform: Council Proposes Rx Exemption For Topical Antimicrobials

 
• By David Ridley

The EU Council has introduced a key amendment to Article 51 (para 1, point e) of the new pharma directive: “A medicinal product shall be subject to medical prescription where it is an antimicrobial, unless intended for topical use.”

AESGP Annual Meeting: Commission Must ‘Think Carefully’ Before Reverse-Switching Antimicrobials

 
• By David Ridley

If the European Commission is serious about improving the competitiveness of the European Union, it should ditch the idea of making commonly used OTC antimicrobials like thrush treatments and cold sore creams prescription-only, warns Greek Medicines Agency president Evangelos Manolopoulos

Over The Counter: Driving Innovation In France’s Self-Care Market, With NèreS’ Luc Besançon

 
• By David Ridley

HBW Insight speaks to NèreS' executive director Luc Besançon about the key issues facing France's self-care industry, especially Rx-to-OTC switch and the revised Urban Wastewater Treatment Directive.

Allergy Ingredient Itch Warning, ACNU Final Rule Scratch Extent Of FDA Authority For Label Changes

 
• By Malcolm Spicer

Effective date for ACNU OTC switch final rule and finding of severe itching from long-term use of common allergy ingredients are bookends for limits of FDA’s authority for product label changes.

More from Health

AESGP Annual Meeting: Consumer Health Sector Still Safe Bet For Investors

 
• By David Ridley

A healthy diversity of different types of players and plenty of space for scaling up are among the reasons that investors remain interested in the consumer health sector, according to investment bankers speaking at the recent AESGP Annual Meeting.

US FDA May Consolidate Support Services After Extensive Cuts

 
• By Derrick Gingery and Sue Sutter

Commissioner Martin Makary told staff that plans are being developed to centralize HR, IT, travel and other functions, which were heavily impacted by the 1 April reduction-in-force.

People On The Move: Appointments At AESGP, PGEU, Nicapur

 
• By Tom Gallen

A round-up of the latest European health & wellness appointments: Workman re-elected AESGP chair; PGEU names 2026 leadership; Nicapur gets managing director.