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Teva asks SCOTUS to overturn “skinny label” verdict on GSK drug

pharmaphorum

The case hinges around the concept of “ skinny labelling ” which was introduced to stop drugmakers extending the exclusivity period for their branded medicines – through a stream of new indications or patient populations – that can be protected with so-called “use” patents. The substance patent expired in 2007.

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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. A recent state law failure-to-warn case in the SDNY makes that very point.

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Zyrtec generic availability, cost, and dosage

The Checkup by Singlecare

Since 2008, it has been available in both brand and generic forms and can be purchased as an over-the-counter product. The first generic of prescription Zyrtec, cetirizine, was approved by the FDA in 2008, around the time the medication became available over the counter. Pharmacist (2008) Generic drug facts , U.S.

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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Clopidogrel interactions to avoid

The Checkup by Singlecare

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.

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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. Using an approved drug for an unapproved use is called off-label use.

Dosage 52
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Dramamine interactions to avoid

The Checkup by Singlecare

Sources Dimenhydrinate (Rx, OTC) interactions , Medscape Dramamine–dimenhydrinate tablet, chewable drug label , DailyMed (2023) Dramamine original formula–dimenhydrinate tablet drug label , DailyMed (2023) H1 antihistamines: Current status and future directions , World Allergy Organization Journal (2008) The blood-brain barrier: An overview: Structure, (..)