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Perrigo Company PLC

http://www.perrigo.com/

Latest From Perrigo Company PLC

Pending Decision On First US OTC Birth Control Shines Spotlight On Self-Report Study Data

Approval likely would account for all weight on scale of FDA decision if not for self-report element in design of HRA Pharma’s actual use study for OTC switch of 0.075-mg norgestrel branded Opill. HRA’s sNDA offers lesson for using electronic diary apps in self-report studies.

FDA Prescription To OTC Switch

The Power Of The Open Public Hearing

The US FDA took three high profile applications to an external advisory committee meeting during the week of 8 May – and offered a very skeptical read on the approvability of each. All three won positive votes from the committees, in no small part thanks to the messages delivered during the Open Public Hearings.

Advisory Committees Drug Review

When History Has Its Eyes On You: Opill Vote Puts US FDA In Tough Spot

A unanimous US FDA advisory committee vote in favor of a landmark decision to make oral contraceptives available without a prescription should be history in the making. But the desire to make history – rather than address FDA’s significant concerns with the actual application for Perrigo’s Opill – seems to have carried the day.

Advisory Committees Women's Health

When History Has Its Eyes On You: Opill Vote Puts US FDA In Tough Spot

A unanimous US FDA advisory committee vote in favor of a landmark decision to make oral contraceptives available without a prescription should be history in the making. But the desire to make history – rather than address FDA’s significant concerns with the actual application for Perrigo’s Opill – seems to have carried the day.

Advisory Committees Women's Health
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Company Information

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  • Pharmaceuticals
    • Generic Drugs
    • Nutraceuticals
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  • Biotechnology
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  • Other Names / Subsidiaries
    • Agis Industries
    • Chemagis
    • Clay-Park Labs
    • Cobrek Pharmaceuticals
    • Elan Corporation
    • JB Laboratories
    • Onclave Therapeutics Limited
    • Omega Pharma Invest N.V.
    • Paddock Laboratories
    • Omega Pharma Invest N.V.
    • Ranir Global Holdings LLC
    • Rosemont Pharmaceuticals Ltd.
    • Unico Holdings Inc.
    • Velcera, Inc.
    • Geiss, Destin & Dunn, Inc.
    • High Ridge Brands
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