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FDA-Approved Labeling: Is Enough Enough?

The FDA Law Blog

Livornese — I saw the sign…and the answer is no—FDA-approved labeling apparently is not enough under state failure-to-warn laws, according to certain courts.

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Zyrtec generic availability, cost, and dosage

The Checkup by Singlecare

Zyrtec was approved by the United States Food and Drug Administration (FDA) in 1995. Since 2008, it has been available in both brand and generic forms and can be purchased as an over-the-counter product. Some off-label uses of Zyrtec or cetirizine include atopic dermatitis (the most common type of eczema ) and hives.

Dosage 52
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New Legislation Would Cut Off Access To The Courts And Immunize FDA Actions From Timely Judicial Review

The FDA Law Blog

Senate Committee on Health, Education, Labor and Pensions (“Senate HELP”) is scheduled to take up legislation that could significantly limit access to the courts and immunize critical FDA decisions from timely judicial review. Subsection 505(q) initially was added by Section 914 of the 2007 FDA Amendments Act (“FDAAA”), Pub.

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Can you buy metformin over the counter?

The Checkup by Singlecare

Metformin hydrochloride is a generic drug approved by the Food and Drug Administration (FDA) to help manage blood sugar levels in people with type 2 diabetes mellitus. It can also be used off-label for weight loss. For weight loss, the only FDA-approved OTC weight-loss pill available is Alli (orlistat).

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Abilify generic availability, cost, and dosage

The Checkup by Singlecare

Abilify generic | Abilify vs. aripiprazole | Cost | Off-label use | How to switch Abilify is a brand-name medication approved to treat certain mental health conditions, including the treatment for schizophrenia , bipolar disorder , and major depressive disorder. Abilify first received FDA approval in 2002. mL, 960 mg/3.2

Dosage 52
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Paradoxical Excitation from DPH Sleeping Pills

The People's Pharmacy

You would think that the FDA would require some information on the label of PM pain relievers that warns about this paradoxical excitation reaction. You would hope that there would be some mention of such a contradictory complication on the label of OTC PM sleeping pills. Crazy, right? Natural Approaches to Insomnia?

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Prednisone for gout: Dosage, safety, and more

The Checkup by Singlecare

The drug’s label recommends doses of 5–60 mg per day. Food and Drug Administration ( FDA ), some common side effects include: Headache Nausea Increased appetite Trouble sleeping Weight gain Fatigue Fluid retention Acne Prednisone may also cause certain serious side effects. Is colchicine or prednisone better for gout?

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