New Drugs Approved by the FDA;New Dosage Forms and Indications Approved by the FDA;Agents Pending FDA Approval;Significant Labeling Changes or “Dear Health Professional” Letters Related to Safety

Abstract

This monthly feature will help readers keep current on new drugs, new indications, dosage forms, and safety-related changes in labeling or use. Efforts have been made to ensure the accuracy of this information; however, if there are any questions, please let me know at bakerdan@wsu.edu.

Table 1.

New drugs approved by the US Food and Drug Administration (FDA): January 19, 2011 through February 18, 2011

Generic name Brand name (Company)	Comparative agents	Indication	Mechanism of action	Common adverse effects	Dosage form and strength	Package insert
Factor XIII Concentrate (human) Corifact (CSL Behring)	Factor concentrates	Treatment of congenital Factor XIII deficiency	Replacement therapy	Hypersensitivity reactions, chills, fever, arthralgia, headache, elevated thrombin-antithrombin levels, increased hepatic enzymes	Injection vials containing 1000-1600 units	http://www.corifact.com/docs/Corifact-Prescribing-Information.pdf
Gabapentin Gralise (Depomed)	Gabapentin	Treatment of post-herpetic neuralgia	Prevents allodynia and hyperalgesia	Dizziness, somnolence, headache	Tablet 300 and 600 mg	http://www.accessdata.fda.gov/drugsatfdadocs/label/2011/022544s000lbl.pdf
Hydroxyprogesterone caproate Makena (Hologic, Inc.)	Progestins	Reduce the risk of preterm birth in women with a singleton pregnancy who have a history of singleton spontaneous preterm birth	Unknown; synthetic progestin	Injection site pain, swelling, pruritus, nodule, and urticaria; nausea, diarrhea	Injection 1250 mg	http://www.accessdata.fda.gov/drugsatfdadocs/label/2011/021945s000lbl.pdf
Vilazodone HCl Viibryd (Trovis Pharma)	Antidepressants	Treatment of major depressive disorder in adults	Selective inhibition of serotonin reuptake and partial agonist at serotonergic 5-HT1A receptors	Diarrhea, nausea, vomiting, and insomnia	Tablet 10, 20, and 40 mg	http://www.viibryd.com/NDA_22567_012111.pdf

Table 2.

New dosage forms and indications approved by the FDA: January 19, 2011 through February 18, 2011

Generic name	Brand name (Company)	Indication and comments
New dosage forms/strength/route of administration
Fexofenadine	Allegra (sanofi-aventis)	Prescription to over-the-counter switch
New indications
Meningococcal [Groups A, Cy, Y and W-135] oligosaccharide diphtheria CRM197 conjugate vaccine	Menveo (Novartis)	Expanded approved age group to include children from 2 to 10 years
Rituximab	Rituxan (Genentech)	First-line maintenance treatment for patients with advanced follicular lymphoma who responded to an initial treatment with rituximab

Table 3.

Agents pending FDA approval: January 19, 2011 through February 18, 2011

Generic name	Brand name (Company)	Indication and comments
Complete response letter: more information required
Dutasteride	Avodart (GlaxoSmith Kline)	No details in the press release for why the FDA did not approve this drug for the reduction of prostate cancer risk in men at increased risk for the disease (elevated serum prostate-specific antigen)
Naltrexone / bupropion extended-release	Contrave (Orexigen Therapeutics)	Letter indicates a new clinical trial is necessary to evaluate the long-term cardiovascular safety of this combination in obese patients. This action was a reversal of the approvable vote by the FDA's advisory panel.
Agents scheduled for review by an FDA advisory panel
Fidaxomicin	Fidaxomicin (Optimer Pharmaceuticals)	Treatment of adults with Clostridium difficile infection and prevention of recurrences

Table 4.

Significant labeling changes or “Dear Health Professional” letters related to safety^a

Generic Name Brand Name (Company)	Warning	Web site
Terbutaline (various)	Terbutaline should not be used in pregnant women for prevention or prolonged treatment (beyond 48 to 72 hours) of preterm labor in either the hospital or outpatient locations because of the potential for serious adverse reactions (eg, maternal increased heart rate, cardiac arrhythmias, death, hyperglycemia, hypokalemia, pulmonary edema, and myocardial ischemia).	http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm243840.htm

Practitioners are encouraged to check the FDA's MedWatch Web site (http://www.fda.gov/medwatch/safety.htm) for updated information.