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First OTC Birth Control Pill Approved In US Will Launch With Three-Year Market Exclusivity

 
• By Malcolm Spicer

FDA approval of Perrigo subsidiary HRA’s application comes 60 years after Rx birth control was approved in the US, one year after the application was submitted, and 13 months after the Supreme Court’s Dobbs ruling. Perrigo plans to launch sales in 2024 first quarter.

• Source: Shutterstock/HBW Insight

Perrigo Company PLC has launched an OTC switch before, but its first with three-year market exclusivity will be Opill, approved as the first nonprescription daily oral contraceptive available in the US.

The Food and Drug Administration's approval announced on 13 July of Perrigo subsidiary HRA Pharma’s supplemental new drug application, 60 years after Rx birth control's initial approval in the US...

An HRA representative told HBW Insight that the Paris-based firm, which Perrigo acquired in 2022, was granted market exclusivity for Opill by the FDA.

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• By Tom Gallen

A round-up of the latest consumer health people moves: ANEFP elects president; Inula Group appoints CEO; Opella names ANZ head.

Over The Counter: Taking Real-World Evidence Seriously, With IQVIA Consumer Health’s Volker Spitzer

 
• By David Ridley

In part 2 of HBW Insight's interview, IQVIA Consumer Health's vice president of global research and development and real-world evidence services, Volker Spitzer, explains how to approach real world evidence so that regulators recognize its validity, in supporting Rx-to-OTC switch applications, for example.

Value Of Consumer Wearables Within The Clinic Currently Unknown, Says Cardiologist

 
• By Natasha Barrow

“It’s quite likely [consumer wearable manufacturers] are changing the sensitivity and specificity based on consumer feedback, but not for medical reasons,” said Dipak Kotecha, a University of Birmingham professor of cardiology. Often, self-reported performance evidence from manufacturers is “low quality and biased.”