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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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When FDA-Approved Generics Fail: Brand Wellbutrin XL Antidepressant is Cheaper from Canada

Pharmacy Checkers

Years ago, they took on the Food and Drug Administration in regards to Budeprion XL distributed by Teva Pharmaceuticals, the supposed generic equivalent to the popular antidepressant, Wellbutrin XL. Many readers complained that it just wasn’t cutting it compared to the brand name version. Just switch back to the brand!”

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Skinny Label and Induced Infringement: The Saga Continues

FDA Law Blog

Specifically, the Government explained, “[t]he section viii pathway cannot function properly if FDA and generic manufacturers cannot rely on an NDA holder’s representations to the agency regarding which portions of the brand-name drug’s labeling teach patented methods of use.”

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Can you trust Turkey-approved Alipza? Is it the same as U.S.-Approved Livalo?

Pharmacy Checkers

A friend of mine, who has very difficult to control cholesterol, was prescribed Livalo, an FDA-approved brand of the drug pitavastatin. He went to our site to discover that brand-name Livalo ( pitavastatin ). That brand-name pitavastatin , sold in Turkey, is sold under the name Alipza – not Livalo. Is the drug safe?

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FDA-Approved Labeling: Is Enough Enough?

FDA Law Blog

FDA approves (or sometimes dictates depending on the product and regulatory pathway to market) the content of drug product labeling to set forth the conditions of use for which the benefits of the product outweigh the risks. More than a few have taken far longer—literally decades.

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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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Ding Dong is the Skinny Label (Effectively) Dead?

FDA Law Blog

Typically, generic sponsors carve out a patent-protected indication or patient population, but technically, any method of use can be carved out as long as FDA determines that the product can still be used safely and effectively without the patent-protected information. The catch is, as we have learned from the GSK v.