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Europe names hundreds of critical medicines in quest to counter drug shortages

Fierce Pharma

Over the past several years, drug shortages have vexed doctors and patients on both sides of the Atlantic, prompting lawmakers and government agencies to take action in both Europe and the U.S. Tuesday, the European Medicines Agency laid out a list of more than 300 critical generic drugs that could fall prey to future shortages.

Medicine 143
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Disruption in healthcare is coming

World of DTC Marketing

The new initiative, Care Studio, aims at doctors rather than patients. Then there is the cost of generic drugs. A recent study in the An­nals of In­ter­nal Med­i­cine took a look at al­most 90 gener­ic drugs that the Medicare Part D pro­gram pays for, find­ing that Medicare could’ve saved $3.6

Pharmacy 227
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First Generic Version of AZOPT® (brinzolamide ophthalmic suspension) 1%, used to treat high pressure inside the eye

The Pharma Data

“This first-to-market generic version of AZOPT ® (brinzolamide ophthalmic suspension) 1% in the U.S. provides patients with another important treatment option,” said Christine Baeder, SVP, Chief Operating Officer US Generics, Teva USA. What should I tell my doctor before taking brinzolamide ophthalmic suspension 1%?

Doctors 52
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Teva Announces Launch of an Authorized Generic of Epiduo® Forte Gel (adapalene and benzoyl peroxide gel 0.3%/2.5%), in the U.S.

The Pharma Data

“The launch of our first-to-market authorized generic version of Epiduo® Forte Gel in the U.S. provides patients with another important treatment option,” said Christine Baeder, SVP, Chief Operating Officer US Generics, Teva USA. Talk to your doctor if you are pregnant or plan to become pregnant.

Doctors 52
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Our abysmal health care system

World of DTC Marketing

First, the health insurance companies are making a lot of money while burying doctors in paperwork and limiting treatment options. Patients and doctors are tired, and insurance companies are raising rates after two years of making a surplus because nobody went to the doctor during the pandemic. The result:?

Doctors 263
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Skinny Label and Induced Infringement: The Saga Continues

FDA Law Blog

Agreeing with Judge Prost’s dissents in the Federal Circuit’s initial and rehearing decisions in this case, the Government argues that a generic’s labeling should not be treated as evidence of intent to induce infringement where that generic “plays by the rules of the section viii pathway” (internal citations omitted).

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FDA-Approved Labeling: Is Enough Enough?

FDA Law Blog

Brand drugs, generic drugs, and medical devices alike have all been the target of state failure-to-warn litigation; in a recent case, OTC acetaminophen is the target. According to FDA, therefore, use in pregnant women is neither condoned nor directed by the labeling—that’s a question for them to discuss with their doctors.