US FDA approves Accentia's Xodol

Florida, USA-based Accentia Biopharmaceuticals says that its manufacturing partner has received approval from the Food and Drug Administration for a new dosage of Xodol (hydrocodone bitartrate and acetaminophen tablets, USP), its unique combination painkiller.

According to Accentia, the product combines hydrocodone, a narcotic widely-used for pain, together with the lowest effective dose of acetaminophen, the most commonly-used analgesic, in a formulation that reduces the possibility that the patient will exceed the recommended daily allowance of acetaminophen. This is up to 4,000mg per day for less than 10 days, and no more than 2,600mg per day for longer-term use. Higher cumulative doses of the analgesic have been shown to predispose patients to adverse effects, including liver damage, the firm noted.