FDA Approves Oral Disintegrating Tablet Version of Biovail's Tramadol
Biovail has received FDA approval for Tramadol ODT, an orally disintegrating tablet version of the analgesic.
Intended for the treatment of moderate-to-moderately severe pain in adults, Tramadol ODT (tramadol HCl) will be sold in a 50-mg dosage strength. The approval came after Biovail successfully addressed concerns raised by the FDA in a January approvable letter, which identified numerous labeling issues.
Alpharma Receives Tentative Approval for Kadian Capsules
The FDA has given tentative approval to Alpharma for its application for Kadian (morphine sulfate) capsules in a 200-mg dose.
The painkiller is currently marketed in 20-, 30-, 50-, 60- and 100-mg dosages.