FDA Actions

FDA Actions

The FDA has approved vilazodone hydrochloride for the treatment of depression in adults. The drug is a selective serotonin reuptake inhibitor as well as a partial agonist of the 5HT 1a receptor. The drug was approved in dosages of 10 mg, 20 mg, and 40 mg for major depressive disorder or major depression. Vilazodone is touted as having fewer sexual side effects than other antidepressants. It carries the same boxed warning as other antidepressant regarding suicidal thinking and behavior in children, adolescents, and young adults. Vilazodone will be marketed by Clinical Data Inc. as Viibryd.

The FDA is limiting the amount of acetaminophen in combination prescription pain medications. The new requirement limits the amount of acetaminophen to 325 mg in each tablet or capsule. Common medications that will be affected include codeine (acetaminophen with codeine), oxycodone (Percocet^®), and hydrocodone (Vicodin^®). Over-the-counter acetaminophen products are not affected. This action is being taken to limit acetaminophen-related liver failure. It is felt that lowering the amount of acetaminophen in these products will have minimal effect on efficacy for treating pain. The change will be phased in over 3 years.

The FDA has approved a new transmucosal form of fentanyl for the treatment of breakthrough pain for adults with cancer. The drug is indicated for the management of breakthrough pain in patients with cancer ages 18 and older, who use opiate pain medication around the clock. Breakthrough pain is defined as pain that comes on suddenly for short periods of time and is not alleviated by the patient's normal pain management plan. Patients must be opioid-tolerant to qualify for use with transmucosal fentanyl. The drug is available only through a Risk Evaluation and Mitigation Strategy (REMS) program, which is intended to minimize risk of misuse, abuse, addiction, and overdose. Fentanyl sublingual tablets are available as 100 mcg, 200 mcg, 300 mcg, 400 mcg, 600 mcg, and 800 mcg strengths. Fentanyl sublingual tablets are marketed by ProStrakan Inc. under the trade name Abstral^®.