FDA Roundup: Generic Abilify, API Recall, Chin Injections
Aripiprazole—Schizophrenia and Bipolar Disorder
The Food and Drug Administration (FDA) has approved the first generic versions of Abilify for the treatment of fecal schizophrenia and bipolar disorder.1
The drug (aripiprazole) met the bioequivalence of the brand name and has been approved for marketing in multiple dosage forms and stregnths.
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“Having access to treatments is important for patients with long-term health conditions,” explained John Peters, MD, acting director of the Office of Generic Drugs in the FDA’s Center for Drug Evaluation and Research.1
“Health care professionals and consumers can be assured that FDA-approved generic drugs have met the same rigorous standards as the brand-name drug,” he said.1
Adverse reactions for aripiprazole include uncontrollable limb and body movements, anxiety, restlessness, insomnia, headache, dizziness, nausea, and vomiting. 1
Kybella – Chin Fat
The FDA has announced approval for the use of Kybella acid (deoxycholic acid) to treat patients with moderate-to-severe submental fat (fat underneath the chin). 2
Kybella works by helping the body absorb fats. The cytolytic drug destroys fat cells after it is injected directly into the submental fat tissue 2
In 2 clinical trials including 1022 patients with moderate-to-severe submental fat, participants were randomly administered Kybella or a placebo for up to 6 treatments. The finings demonstrated that those who received Kybella experienced more frequent reductions in submental fat compared to those who received the placebo. 2
“Treatment with Kybella should only be provided by a licensed health care professional, and patients should fully understand the risks associated with use of the drug before considering treatment,” said Amy G. Egan, MD, MPH, deputy director of the Office of Drug Evaluation III in the FDA’s Center for Drug Evaluation and Research.
“It is important to remember that Kybella is only approved for the treatment of fat occurring below the chin, and it is not known if Kybella is safe or effective for treatment outside of this area,” she said.2
Serious side effects included difficulty swallowing, facial muscle weakness, or an even smile from nerve damage in the jaw. More common side effects included bruising, swelling, numbness, paid, redness and hard areas in the treated area.2
Recall: APIs – Active Pharmaceutical Ingredients
Attix, a Candadian-based company, is recalling all non-penicillin active pharmaceutical ingredients (API)s distributed and repackaged between January 5, 2012 to February 13, 2015.3
The company was forced to recall hundreds of bulk APIs after discovering that their packaging facility did not properly separate penicillin APIs from the non-penicillin APIs.3
The recent FDA Enforcement Report noted that the number of recalls has reached 479.3
According to the FDA, The APIs were sold to compounding pharmacies and research facilities. The inspection tracker for Health Canada noted that Attix does not currently have a license and has voluntarily ceased selling their products.3
—Michelle Canales Butcher
References:
1. FDA. FDA approves first generic abilify to treat mental illnesses [press release]. www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm444862.htm. Accessed April 30, 2015.
2. FDA. FDA approves treatment for fat below the chin [press release]. www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm444978.htm. Accessed April 30, 2015.
3. Fierce Pharma Manucfacturing. Attix pharmaceuticals recalls hundreds of APIs from the US [press release]. www.fiercepharmamanufacturing.com/story/attix-pharmaceuticals-recalls-hundreds-apis-us/2015-04-30. Accessed May 30, 2015.