Hot Topics
New Unapproved Drug Seizure
On April 9, U.S. Marshals seized over 14,000 units of natural supplements marketed toward treatment of erectile dysfunction. FDA had previously learned that the supplements contained undeclared active ingredients that are found in FDA-approved prescription erectile dysfunction drugs such as Viagra, Cialis, and Levitra. As such, they should be considered drug products and should have been approved by FDA. The products originated in China and were distributed by Shangai Distributors in Puerto Rico. In previous months, Hop Topics has highlighted FDA’s recent focus on enforcing regulations regarding marketing of unapproved drugs such as these. Here you’ll find, along with documents on erectile dysfunction drugs, FDA’s policy guide on Marketed Unapproved Drugs.
Tussionex Warning
In March, FDA issued an alert to patients and health care professionals on the importance of using and prescribing Tussionex cough medicine according to its labeling. Tussionex Pennkinetic Extended-Release Suspension is a strong cough medication containing hydrocodone and chlorpheniramine. If not used carefully, the product can pose serious risk of overdose. Care is urged in making sure that the medication is not taken by children under 6 years of age, that only the recommended dose is taken, and that the medication is not taken more frequently than every 12 hours. Order approval documents or adverse event information on Tusssionex here.
Best-Selling Transcripts
Which committee meetings are your colleagues reading about? Back by demand, find out here with our list of best-selling transcripts. These transcripts cover a variety of topics, from oxycontin to pediatric studies. Don’t miss out on these valuable reports.