- Atomoxetine capsules (Strattera)1
- Clonidine transdermal system USP (catapres-TTS)2
- Enoxaparin sodium injection (Lovenox)3
- Naratriptan hydrochloride 2.5-mg tablets (Amerge)4
New Drugs, Devices, Indications, and Dosage Forms
- A combination tablet containing both aliskiren and amlodipine (Tekamlo) has been approved by the FDA for the treatment of hypertension (HTN).5 Four strengths for once-daily dosing are available.
- Antihemophilic factor VIII (recombinant) injection (Xyntha) for treatment of hemophilia A has been approved by the FDA in a pre-filled, dual-chamber syringe for intravenous (IV) infusion following reconstitution of the freeze-dried powder with 0.9% sodium chloride diluent (both supplied in the dosage form).6 The first dose will be available in the 3,000 international units strength (4 mL). Other dosages will be available in 2011.
- Bimatoprost ophthalmic solution 0.01% (Lumigan) has been approved by the FDA as a first-line treatment for reducing intraocular pressure in patients with open-angle glaucoma or ocular hypertension.7
- Buprenorphine/naloxone sublingual film (Suboxone sublingual) has been approved by the FDA for the treatment of opioid dependence.8
- Coagulation factor VIIa room temperature stable (recombinant) (NovoSeven RT) has been approved by the FDA in an 8-mg vial.9 This larger size allows rapid initiation and administration of this product for patients who need a larger dose. Additionally, this product is approved for an extended shelf life, for all vial sizes, to 36 months at room temperature.
- Donepezil 21-mg tablets (Aricept) have been approved by the FDA for the treatment of moderate to severe Alzheimer’s disease.10
- Glycopyrrolate cherry-flavored oral solution (Cuvposa) has been approved by the FDA as an orphan drug for treating chronic severe drooling in patients ages 3 to 16 with neurological conditions such as cerebral palsy.11
- Immune globulin subcutaneous (human) 20% liquid (Hizentra) has been approved by the FDA for a 24-month shelf life at room temperature when protected from light.12
- Miconazole 50-mg buccal tablets (Oravig) have been approved by the FDA to topically treat oropharyngeal candidiasis in patients 16 and older.13
- Niacin extended release/simvastatin tablets (Simcor) have been approved by the FDA in two new dosage strengths: 500 mg/40 mg and 1000 mg/40 mg.14
- Olmesartan medoxomil, amlodipine besylate, and hydrochlorothiazide tablets (HCTZ) (Tribenzor) have been approved by the FDA in a single tablet to treat hypertension (not initial therapy).15 This combination should not be used in patients with a creatinine clearance <30 mL/minute, or in patients with renal artery stenosis.
- STX-100 has received orphan drug status for treating idiopathic pulmonary fibrosis (IPF) for which there currently are no FDA-approved treatments.16 STX-100 is a humanized, monoclonal antibody that targets integrin vb6, which exhibited major antifibrotic activity in preclinical animal models of the lung and other organs. The FDA previously granted orphan drug designation for STX-100 for chronic allograft nephropathy. A Phase 2 trial in IPF is planned for 2011.
- Docetaxel injection concentrate (Taxotere) has been approved by the FDA in a one-vial system, which eliminates the dilution step.17
- Valganciclovir injection (Valcyte) is FDA-approved for an increased therapy length (200 days) in adult renal transplant patients at high risk of developing cytomegalovirus disease (CMV).18 This extends the length of therapy from 100 days.
Safety, Warnings, and Label Changes
- Carbidopa/levodopa and entacapone tablets (Stalevo) are undergoing a safety review in relation to a possible increased cardiovascular event risk, including myocardial infarction, stroke, and cardiovascular death, compared with patients only taking carbidopa/levodopa.19 An FDA meta-analysis of 15 clinical trials found a small increased risk of cardiovascular events. However, this meta-analysis was not specifically designed to assess cardiovascular safety, and most patients had pre-existing cardiovascular disease risk factors, so even small differences in the level of these risks could significantly affect the study outcomes. Additionally, most negative cardiovascular events occurred in a single trial. The FDA recommends regular evaluation of patients’ cardiovascular status.
- Tigecycline IV injection (Tygacil) has undergone a label change in its “Warnings” and “Precautions” in relation to an increased mortality risk.20 A pooled analysis compared tigecycline use to other similar antibacterials for managing different serious infections. Patients who had a greater increased risk of death were those with hospital-acquired pneumonia, ventilator-associated pneumonia, complicated skin and skin structure infections, diabetic foot infections, and complicated intra-abdominal infections.