1. HBW Insight
  2. >>Health
  3. >>Rx-to-OTC Switch

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ACNU rule published in June, but the firm, which worked with Ibis Reproductive Health on proposal, had time to plumb a draft guidance FDA published in 2018 on novel switches.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

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on HBW Insight for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from Rx-to-OTC Switch

PAGB: UK Gov Must Invest In Self-Care To Realize ‘Untapped Potential’

 
• By David Ridley

Reacting to chancellor Rachel Reeves' 2025 public spending review, PAGB welcomed increased funding for healthcare and life sciences while stressing the need to promote self-care practices.

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.

More from Health

Over The Counter: EU Omnibus And ESG, What You Need To Know, With CEN Group’s Jasper Crone

 
• By David Ridley

HBW Insight catches up with sustainability expert Jasper Crone to find out what consumer health companies need to know about the European Commission's Omnibus simplification package.

TheraBreath ‘Guarantee Better’ Claim Serious, Not Puffery With Founder Prominent In Advertising

 
• By Malcolm Spicer

Challenged advertising, which appeared in a TV commercial, in-store displays and advertising on social media, included express claims “It’s a better mouthwash. I guarantee it.” and “I guarantee it. – ‘Dr. Harold Katz.’”

US Consumer Health Sector Vigilant To Avoid Stumbling On Trump’s Tariff Twists And Turns

 
• By Malcolm Spicer

In remarks at recent investor conference reflecting comments from across the US consumer health sector, Kenvue chief Thibaut Mongon says, “I'm going to state the obvious. The environment is very fluid.”