Ephedra seizure
This article was originally published in The Tan Sheet
Executive Summary
More than 2 mil. capsules of Asia MedLabs' ephedra-containing Vitera-XT were seized from the firm's facility in Houston by U.S. Marshals, FDA announces Nov. 23. Vitera-XT, a "traditional Asian formulation," lists ephedrine alkaloids among its ingredients and carries claims such as "treat[s]...persistent flu, fevers and [may be used] for protein release." The complaint the ingredients and claims render the product an "unapproved new and misbranded drug." FDA's final rule banning the botanical was published in February (1"The Tan Sheet" Feb. 9, 2004, p. 10)...
You may also be interested in...
Ephedra Ban Effective In April; FDA Will Follow-Up On Internet Firms
A 1final rule prohibiting the sale of dietary supplements containing ephedrine alkaloids will become effective April 12, FDA announced Feb. 6
Alvotech Highlights Lack Of Simponi Rivals As It Delivers Golimumab Results
Alvotech has just become the first company to announce positive topline results from a confirmatory clinical study for a proposed golimumab rival to Simponi and Simponi Aria – and moreover, the firm sees limited competition from other biosimilars on the horizon.
Xbrane Assembles The Troops As FDA Says No To Lucentis Biosimilar
Xbrane Biopharma was riding the crest of a wave with the EU launch of its biosimilar to Lucentis, following years of toil and investment. However, plans to roll out the product in the US will have to be pushed back – likely – into the middle of 2025, following a US FDA complete response letter.