From India with H1N1 claims
This article was originally published in The Tan Sheet
Executive SummaryFDA warns an online firm based in India, 1www.ayurvediccure.com, it is marketing herbal products as unapproved drugs because they claim to prevent or treat the H1N1 flu virus. The agency's Jan. 26 warning letter says the noncompliant products include tinospora cordifolia, holy basil and ginger capsules. FDA has not approved the products to diagnose, mitigate, prevent, treat or cure H1N1, according to the letter posted on FDA's Web site April 7. The product claims on the firm's Web site included, "Regular uses of these medicines are helpful in controlling the signs and symptoms of deadly swine flu and help in early treatment of influenza." FDA says until the firm removes unapproved claims, it will include the firm's name in a list on the agency's Web site with other businesses that received warning letters about unapproved H1N1-related products
You may also be interested in...
The amyloid-targeting drug is years behind Biogen/Eisai’s aducanumab, but its subcutaneous administration and the GRADUATE studies’ design could give Roche’s gantenerumab an advantage.
Correvio's atrial fibrillation drug Brinavess will return to a US FDA advisory committee more than a decade after the agency first declined to approve the drug; FDA still has a series of cardiovascular safety concerns related to the drug and is not convinced by data from the European experience.