article thumbnail

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.

article thumbnail

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.

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

Trending Sources

article thumbnail

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
article thumbnail

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.

article thumbnail

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?

article thumbnail

Developing the EU’s first intestinal microbiota-based biologic

European Pharmaceutical Review

This randomised, open label-controlled multicentre clinical trial was conducted across 21 sites in Spain from 2021 to 2023. 2017; 55(7):1998-2008. The study included 92 adult patients with confirmed CDI. Peng Z, Jin D, Kim HB, et al. J Clin Microbiol. About the author Dr Olaia Aurtenetxe is the Head of Clinical Research at Mikrobiomik.

article thumbnail

Can you buy metformin over the counter?

The Checkup by Singlecare

It can also be used off-label for weight loss. OTC metformin substitutes for weight loss In certain situations, healthcare providers may prescribe metformin off-label for weight loss. In a 2008 study , researchers found berberine was safe and effective for the treatment of type 2 diabetes.

FDA 69