- Anastrazole tablets (generic Arimidex)1
- Azelastine hydrochloride ophthalmic solution 0.05% (generic Optivar)2
- Aztreonam for injection in single-dose vials of 1 g/20 mL and 2 g/30 mL (generic Azactam)3
- Bupropion hydrochloride extended-release 150-mg tablets (generic Zyban)4
- Meropenem injection, USP, IV, 500-mg and 1-g vials (generic Merrem IV)5
- Levetiracetam injection in 100 mg/1 mL and 500 mg/5 mL single-use vials (generic Keppra injection)6
- Tacrolimus 5-mg capsules (generic Prograf)7
- Trandolapril/verapamil tablets (generic Tarka)8
- Valacyclovir hydrochloride tablets, USP (generic Valtrex)9
- Venlafaxine extended-release capsules (generic Effexor XR)10
New Drugs, Indications, Approval Recommendations
- The Alair Bronchial Thermoplasty System is the first device to be FDA-approved for treating severe and persistent asthma.11 It is to be used by adults who are still symptomatic despite treatment with high-dose inhaled corticosteroids (ICS) and long-acting beta-agonists (LABAs). Radiofrequency signals are converted into heat that warms the lining of targeted airways via bronchoscope. There are a number of contraindications and warnings for this device. Treatment is delivered using a standard bronchoscope under moderate sedation.
- Buprenorphine Transdermal System (Butrans) is FDA-approved to treat moderate to severe chronic pain in patients requiring continuous, around-the-clock opioid analgesia for an extended period of time.12 It is a Schedule III controlled substance and will be available in early 2011 in 5 mcg/hour, 10 mcg/hour, and 20 mcg/hour dosage strengths. Patches continuously release the drug over seven days.
- Denosumab injection (Prolia) has been approved by the FDA for treating postmenopausal women with osteoporosis at high risk for fractures.13
- Fingolimod (FTY720), an oral sphingosine 1-phosphate receptor (S1PR) modulator and disease-modifying treatment for relapsing-remitting multiple sclerosis (RRMS), has received a positive review by an FDA Advisory Committee.14 The committee voted 25-0, stating that in clinical trials to date that FTY720 has demonstrated substantial evidence of effectiveness in patients with RRMS, reducing the frequency of clinical exacerbations. This agent works by retaining lymphocytes in the lymph nodes, preventing them from entering the central nervous system to cause damage. This lymphocyte retention is reversible, allowing circulating lymphocytes to regain normal levels if treatment is stopped.
- Ketorolac tromethamine intranasal (Sprix) is FDA-approved for treating acute moderate to moderately severe pain requiring opioid-level analgesia for up to five days.15 Even though it is administered intranasally, gastrointestinal hemorrhage, bleeding, and cardiovascular risks are included in the labeling as adverse events.
- HCV Rapid Antibody Test (OraQuick) has been approved by the FDA for use in patients 15 and older to identify hepatitis C virus (HCV) antibodies.16 Available as a test strip, it identifies HCV antibodies within 20 minutes, which allows patients to more quickly present for evaluation and treatment.
- Lopinavir/ritonavir (Kaletra) has been approved by the FDA for once-daily dosing for treatment-experienced HIV patients.17 The agent had been approved for once-daily treatment for therapy-naive patients.
- HPV vaccine (Gardasil) is being evaluated by the FDA in order to potentially expand its indication to include women 27 to 45 years old.18 A decision is expected by the end of the year.
- Roflumilast is a phosphodiesterase 4 (PDE4) enzyme inhibitor that targets underlying inflammation in COPD patients.19 The FDA has issued a complete response letter for Roflumilast, which was filed as a potential treatment to reduce COPD exacerbations associated with chronic bronchitis in patients at risk for exacerbations. No new clinical trials have been requested.
- Estradiol vaginal tablets 10 mcg (Vagifem) will replace estradiol vaginal tablets 25 mcg to treat the symptoms of atrophic vaginitis due to menopause.20 Sales of the 25-mcg formulation were discontinued July 31.
GlaxoSmithKline has received reports of dispensing errors related to rosiglitazone (Avandia), glimepiride (Amaryl), rosiglitazone/metformin (Avandamet), candesartan (Atacand), and warfarin (Coumadin). In some instances, the patient received the wrong medication (one severe case led to impaired mental status). Errors likely occurred due to illegible written prescriptions and/or incorrectly interpreted, labeled, and filled prescriptions. Some of these products have similar dosage strengths and also look alike, leading to the errors.21