FDA-Approved Labeling: Is Enough Enough?
The FDA Law Blog
AUGUST 21, 2023
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.
The FDA Law Blog
AUGUST 21, 2023
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.
The Checkup by Singlecare
FEBRUARY 8, 2024
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.
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The FDA Law Blog
APRIL 30, 2023
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.
The Checkup by Singlecare
OCTOBER 12, 2023
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
The People's Pharmacy
APRIL 10, 2023
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?
The Checkup by Singlecare
FEBRUARY 8, 2024
Clopidogrel and omega-3 fatty acids Omega-3 fatty acids are a popular dietary supplement, often labeled as fish oil capsules. Before you get too upset about this, check with your healthcare provider to see if any change in your coffee consumption is actually advised. Little known to most people, omega-3 fatty acids inhibit platelet activity.
The Checkup by Singlecare
DECEMBER 5, 2023
Levothyroxine (a thyroid hormone) is FDA approved to treat hypothyroidism , a condition in which the body produces less thyroid hormone than your body needs. It’s FDA approved to treat attention-deficit/hyperactivity disorder (ADHD) symptoms, including inattention, hyperactivity, and impulsivity. Approximately 1.2%
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