Market Watch

New Generics

• 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.