AMA Shares OTC Birth Control Diagnosis With FDA

American College of Obstetricians and Gynecologists proposed amending existing AMA policy in anticipation of Perrigo’s HRA business submitting NDA to FDA for OTC switch of progestin-only daily oral contraceptive the end of 2022.

• Source: Shutterstock

The American Medical Association for the first time is encouraging the Food and Drug Administration to make daily oral contraceptives available OTC after previously targeting its suggestion for manufacturers.

The recommendation was announced following a vote during the meeting of the association’s policy-making body on a proposal submitted by...

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

More from Rx-to-OTC Switch

Haleon Study: Self-Care Policies Could Save Finland €60m Per Year

 
• By 

Creating a working group to drive Rx-to-OTC switch is one of the ways in which Finland could expand self-care and save €60m per year for the country's health system, suggests a recently published report commissioned by Haleon.

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

 
• By 

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 

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 

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

More from Health

Moberg Nail Fungus Line Takes Lead In Norway As Firm Plots EU Expansion

 
• By 

Terclara - Moberg’s proprietary topical formulation of terbinafine for fungal nail - has established itself as the market leader in Norway just months after its OTC launch. The firm is now plotting its expansion to additional EU markets.

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

 
• By 

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.

FDA Takes World Tour In Recent OTC Warnings

 

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.