New Drugs Approved by the FDA;New Dosage Forms and Indications;Agents Pending FDA Approval;Significant Labeling Changes

Abstract

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

NEW DRUGS APPROVED BY THE FDA: MARCH 19 TO APRIL 16, 2006

Generic Name Brand Name (Company) (Date of Approval)	Comparative Agents	Indication	Mechanism of Action	Common Adverse Effects	Dosage Form & Strength	PI
Methylphenidate Daytrana (Shire) (4/06)	Methylphenidate	Treatment of attention deficit hyperactivity disorder in children ages 6 to 12 years	Central nervous system stimulant	Sedative, nervousness, irritability	Patch 15 mg	http://www.daytrana.com/pdf/pdf1.pdf

Table 2.

NEW DOSAGE FORMS AND INDICATIONS APPROVED BY THE FDA: MARCH 19 TO APRIL 16, 2006

Generic Name	Brand Name (Company)	Indication/Comment	Dosage Form (Date)
New Dosage Forms/Strength/Route of Administration
Risperidone	Risperdal (Janssen)	Addition of 3 and 4 mg M-TAB, fast-dissolving tablets	Tablet (3/06)
New Indications
Cetuximab	Erbitux (ImClone Systems/Bristol-Myers Squibb)	Use in combination with radiation therapy for the treatment of locally or regionally advanced squamous cell carcinoma of the head and neck (SCCHN) and as a single agent in recurrent or metastatic SCCHN where prior platinum-based chemotherapy has failed	Injection (4/06)
Docetaxel	Taxotere (sanofi-aventis)	Use in combination with cisplatin and 5-fluorouracil for the treatment of patients with advanced gastric cancer	Injection (4/06)
Tacrolimus	Prograf (Astellas Pharma)	Prevention of graft rejection in the recipients of heart transplants	Oral and injection (3/06)
Zanamivir	Relenza (GlaxoSmithKline)	Prevention of influenza in children 5 years of age and older	Inhaler (3/06)

Table 3.

AGENTS PENDING FDA APPROVAL: MARCH 19 TO APRIL 16, 2006

Generic Name Brand Name (Company) (Date of Approval)	Comparative Agents	Indication	Mechanism of Action	Common Adverse Effects	Dosage Form & Strength	Package Insert or Comments
Approvable Agents
Daptomycin Cubicin (Cubist Pharmaceuticals) (3/06)	Vancomycin	Treatment of Staphylococcus aureus bacteremia and endocarditis	Binds to bacterial membranes and causes a rapid depolarization of membrane potential leading to inhibition of protein, DNA, and RNA synthesis	Constipation, diarrhea, nausea, vomiting, dyspepsia, injection side reaction, headache, rash	Injection 500 mg/vial	Currently approved for the treatment of complicated skin and skin structure infections caused by susceptible strains of the following gram-positive microorganisms
PEG 3350, sodium sulfate, sodium chloride, potassium chloride, sodium ascorbate and ascorbic acid for oral solution MoviPrep (Salix) (4/06)	GoLYTELY	Bowel cleansing agent prior to colonoscopy	Laxative	Loose stools, diarrhea, abdominal cramps	Oral
Sitaxsentan sodium Thelin (Encysive Pharmaceuticals) (3/06)	Bosentan	Treatment of pulmonary arterial hypertension	Endothelin (ET) receptor antagonist	Headache, peripheral edema, nausea, nasal congestion, dizziness, liver enzyme abnormalities, reduced hemoglobin	Oral
Agents Scheduled for Review by an FDA Advisory Panel
Dasatinib Sprycel (Bristol-Myers Squibb) (6/06)		Treatment of adults with chronic, accelerated, or blast phase chronic myeloid leukemia with resistance or intolerance to prior therapy, including imatinib	Src tyrosine kinase inhibitors	Thrombocytopenia, neutropenia, tumor lysis syndrome, arthralgia, pyrexia, fatigue, peripheral edema, headache, diarrhea	Oral	Rolling NDA
Rivastigmine Exelon (Novartis) (5/06)	Donepezil	Treatment of mild to moderate dementia associated with Parkinson disease	Cholinesterase inhibitor	Nausea, vomiting, diarrhea, anorexia, fatigue, asthenia, dizziness, somnolence	Capsules and solution
New Drug or Supplemental Applications Filed by Manufacturer
Bevacizumab Avastin (Roche/Genentech) (4/06)	Chemotherapy	Use in combination with platinum-based chemotherapy (carboplatin plus paclitaxel) for previously untreated patients with advanced non-squamous non-small cell lung cancer	Vascular endothelial growth factor (VEGF) antagonist	Nausea, vomiting, arthralgia, asthenia, cough, dyspnea, hemorrhage, headache, fever, hyperglycemia, skin eruptions	Injection
Biskalcitrate potassium, metronidazole, tetracycline Helizide (Axcan Pharma) (3/06)	Antibiotics	Treatment of Helicobacter pylori	Bismuth salt plus antibiotic for eradication of H. pylori	Diarrhea, nausea	Capsule	Will be used in combination with a proton pump inhibitor
Dextromethorphan/quinidine Neurodex (Avanir Pharmaceuticals) (4/06)	Antipsychotics	Treatment of involuntary emotional expression disorder	NMDA antagonist/sigma 1 agonist in combination with a cytochrome P-450-2D6 (CYP2D6) enzyme inhibitor	Diarrhea, dizziness, dizziness, gastrointestinal disorders, nausea, somnolence	Capsule
Rituximab Rituxan (Biogen Idec/Genentech) (3/06)	Chemotherapy agents	Component of the first-line treatment for non-Hodgkin lymphoma	Mouse/human chimeric rDNA pan-B antibody which targets the CD20 cell surface marker	Chills, cytokine release syndrome, fatigue, fever, flu-like symptoms, leucopenia, nausea, alopecia, urticaria, vomiting	Injection	Combination therapy with cyclophosphamide, doxorubicin, vincristine, and prednisone
RSD1235 (Cardiome/Astellas) (3/06)	Anti-arrhythmics	Acute conversion of atrial fibrillation	Potassium channel modulators	Headache, taste disturbances	Injection	Oral formulation also under development
Vildagliptin Galvus (Novartis) (3/06)	Oral hypoglycemic agents	Treatment of type 2 diabetes mellitus	Dipeptidyl peptidase IV (DPP IV) inhibitor	Diarrhea, nausea, hypertension	Oral

Table 4.

SIGNIFICANT LABELING CHANGES OR “DEAR HEALTH PROFESSIONAL LETTERS” RELATED TO SAFETY

Generic Name Brand Name (Company)	Warning	Web Site
All NSAIDs	Addition of class labeling regarding the potential risk of cardiovascular and gastrointestinal adverse effects and the early symptoms associated with Stevens-Johnson Syndrome	http://www.fda.gov/medwatch/SAFETY/2006/jan06.htm
Diazepam rectal gel Diastat AcuDial (Valeant Pharmaceuticals)	Cracks at the base of the plastic tip of some applicators may cause some of the dose to leak out, when the plunger is depressed; which may cause the patient to not receive the full dose of diazepam—this could lead to a sub-optimal therapeutic response	http://www.fda.gov/medwatch/SAFETY/2006/diastat_deardoc_2-22-06.pdf
Nimodipine Nimotop (Bayer HealthCare)	WARNING: death related to inadvertent intravenous administration PRECAUTIONS: changes in blood pressure and risk of bradycardia	http://www.fda.gov/medwatch/SAFETY/2006/Jan_PI/Nimotop_PI.pdf
Pegaptanib sodium Macugen (Pfizer)	Rare reports of anaphylaxis and anaphylactoid reactions, including angioedema	http://www.fda.gov/medwatch/safety/2006/macugen_deardoc.pdf
Tranylcypromine sulfate Parnate (GlaxoSmithKline)	CONTRAINDICATION: history of suicidal behavior	http://www.fda.gov/medwatch/SAFETY/2006/Jan_PI/Parnate_PI.pdf
Valproate sodium/valproic acid/divalproex sodium Depacon/Depakene/Depakote(Abbott)	BOXED WARNING: teratogenicity PRECAUTIONS: risk of hyperammonemia and encephalopathy when used concomitantly with topiramate	http://www.fda.gov/medwatch/SAFETY/2006/Jan_PI/Depacon_PI.pdf http://www.fda.gov/medwatch/SAFETY/2006/Jan_PI/DepakenePI.pdf http://www.fda.gov/medwatch/SAFETY/2006/Jan_PI/Depakote_Sprinkle_PI.pdf