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Oral Contraceptive OTC Proposal Moves Closer With Start Of Actual Use Study

 
• By Malcolm Spicer

HRA Pharma started recruiting in April for an actual use trial, using oral contraceptives with norgestrel 0.075 mg, and expects to complete its study in April 2019, according to clinicaltrials.gov's database. Advocacy group Ibis Reproductive Health, which is working with HRA on an NDA for an OTC oral contraceptive, called the start of the study a "pivotal moment" in moving birth control drugs out of Rx-only.

Birth control dispenser

Recruiting has started for a 900-subject study that could be a key to submitting a new drug application to US FDA for making a daily oral contraceptive available OTC.

HRA Pharma SA started recruiting in April for an actual use trial, using progestin-only oral contraceptives with norgestrel 0.075...

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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: 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

Stada Held Back By Weak Cough & Cold Season

 
• By Tom Gallen

While sales of seasonal products struggled during Q1, Stada pointed to the continuing strength of its underlying Consumer Healthcare portfolio.

AESGP Annual Meeting: Wastewater Directive Impact Assessment ‘Fundamentally Flawed’

 
• By David Ridley

AESGP president Jonathan Workman opens the 61st Annual Meeting with calls for industry unity in the face of the problematic revised EU Urban Wastewater Treatment Directive.