FDA Botanical Review Team Clears Green Tea-Based Drug As First Approval
This article was originally published in The Tan Sheet
Executive Summary
FDA's Botanical Review Team on Oct. 31 approved its first botanical drug, MediGene's Polyphenon E ointment
You may also be interested in...
Chastened By Cold-FX Flop, Afexa Plots U.S. Return Via Botanical Drug Path
Canadian firm Afexa Life Sciences turns its sights southward again, hoping a strong commitment to clinical research will help its flagship Cold-FX product catch on in the U.S.
Dietary Supplements Blossom As Revenue Growth Ingredients For Big Pharma
Dwindling product pipelines are pushing pharmaceutical companies to look to dietary supplements for business opportunities, not only through product sales but also by using herbal substances to develop new drug ingredients
FDA Botanical Drug Products Final Guidance Stresses Batch Consistency
An FDA final guidance on botanical drug products includes new language recommending that firms demonstrate "batch-to-batch consistency" for botanical drug candidates through the clinical development process prior to submitting an NDA