HBW Insight is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By


Rx-to-OTC Switch

Set Alert for Rx-To-OTC Switch

Making Progress On Novel OTC Switch Rulemaking Has FDA Commissioner Nominee Califf’s Attention

Responding to Sen. Roger Marshall’s question on rulemaking to accelerate OTC switches by allowing NDA sponsors to use extra-label information to guide consumers through self-selection of a drug, Robert Califf said he’d support making progress on a proposal FDA began considering in 2012 in its NSURE initiative.

FDA Prescription To OTC Switch

Consider Environmental Risks During OTC Reclassification, Says Sweden's Drugs Regulator

Sweden's national drugs regulator says environmental contamination risks should be reviewed as part of the overall benefit/risk assessment when reclassifying OTCs for sale outside pharmacies.

Sweden Regulation

E-Cigarette Study Suggests Not Limiting Cessation Research To Smokers Interested In Quitting

JAMA study results could spur additional research with subjects from broader pool of candidates for determining whether ENDS products have potential for approval as NRT products. Studies typically limit participants to consumers who want to quit, but expanding pool to include those not interested could add to research results more instances of successful quitting.

FDA Drug Approval Standards

Label Comprehension Results Point Petros Toward OTC Self-Selection Study For Stendra ED Drug

Petros considers switch NDA for Stendra (avanafil), approved for Rx sales in US since 2012 on an NDA by Metuchen. Early indicators showed positive outcomes in a 453-subject label comprehension study for the oral PDE5 inhibitor.

OTC Drugs Prescription To OTC Switch

‘With Chinese Characteristics’ – TCM Driving Rx-To-OTC Switch In China

Traditional Chinese Medicine and regulatory reform are driving Rx-to-OTC switch in China, the country's non-prescription medicines industry association says. Furthermore, Alibaba's "new retail" model of blending online and bricks-and-mortar shopping is fostering innovation in the Chinese market, creating opportunities for international OTC players. However, there is still room for improvement, according to the Global Self-Care Federation's recently published Self-Care readiness Index.

China Health

Over The Counter 22 November 2021: CHC Spin Outs, Supply Chain Issues And Other Q3 Trends

In this episode, HBW Insight’s US and EU editors analyse Q3 OTC business trends, including why the biggest pharmaceutical companies in the world are spinning out their consumer health businesses to create new standalone firms and what's causing the supply chain troubles that are driving up OTC product prices.

International Health

Like Plan B, Approval For OTC Daily Oral Contraceptives In US Could Be An 'Adventure’

It was only after prolonged litigation led a federal judge in 2013 to order FDA not to allow political interference with its science-based decisions that Plan B and generic equivalents became available OTC without age restrictions. “Hopefully, all I can say, it won't happen again,” says reproductive rights advocate Kirsten Moore.

Prescription To OTC Switch FDA

Barriers To US OTC Emergency Contraceptive Sales Remain Despite Court Rebuke Of Restrictions

Continuing impediments include pharmacists and other staff at drug and grocery stores refusing to sell emergency contraceptives, some stores stocking products in locked display cabinets and prices unaffordable to some consumers, says Kelly Cleland, American Society for Emergency Contraception executive director.

FDA Prescription To OTC Switch
See All