article thumbnail

Labetalol batch recalled due to wrong dosage labelling

The Pharmacist

A batch of Labetalol 200mg tablets has been recalled as they are incorrectly labelled as 100mg tablets on the foil blister packaging. Pharmacists have been instructed to immediately stop […] The post Labetalol batch recalled due to wrong dosage labelling appeared first on The Pharmacist.

Dosage 80
article thumbnail

With little FDA oversight, melatonin supplements vary widely in actual dosage, study finds

STAT

One product was even three times more powerful than the label suggested. Researchers tested the melatonin concentration in more than two dozen gummy dietary supplements that recently launched and that were available at mainstream retailers like Amazon and Walmart. Nearly all of the products had more than 10% more melatonin than advertised.

Dosage 246
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

Off-label Use

RX Note

In fact, off-label drug uses can become widely entrenched in clinical practice and become predominant treatments for a given clinical condition. In a study published in JAMA Internal Medicine , off-label use lacking strong scientific evidence had a higher adverse drug event rate compared with on-label use.

article thumbnail

FDA Releases Draft Labeling Guidance for Biosimilar Products

Big Molecule Watch

Last week, FDA released a draft guidance, “ Labeling for Biosimilar and Interchangeable Biosimilar Products ” (“2023 Draft Guidance”) that—when finalized—will revise and replace its July 2018 final guidance, “ Labeling for Biosimilar Products.” The fictitious example provided in the 2023 Draft Guidance is “replicamab-cznm.”

article thumbnail

FDA Publishes Guidance on Labeling Drugs and Biological Products

PharmaTech

The guidance provides examples of required and recommended information in the Dosage and Administration section.

article thumbnail

FDA Tells Congress What It Wants, What it Really Really Wants (it really really really wants a zigazig-ah)

FDA Law Blog: Biosimilars

In the first category, FDA asks Congress to amend the FDCA to require drug manufacturers to disclose full information about the name and quantity of inactive ingredients in product labeling and permit FDA to disclose to generic sponsors the names and amounts of such inactive ingredients.

Labelling 104
article thumbnail

Sandoz granted novel biosimilars approval

European Pharmaceutical Review

As US-approved biosimilars, Wyost and Jubbonti have the same dosage form, route of administration, dosing regime and presentation as the Xgeva ® and Prolia ® , which are are registered trademarks of Amgen Inc. The approval is also accompanied by labelling with safety warnings.