A new drug application (NDA) has been submitted to the Food and Drug Administration (FDA) for Acetavance, an intravenous (IV) form of acetaminophen used in the treatment of acute pain and fever in adults and children who cannot take oral medications.1
An NDA for a low-dose aspirin and esomeprazole combination product has been submitted for risk reduction of low-dose-aspirin-associated gastric and/or duodenal ulcers. A supplemental NDA was submitted for esomeprazole for risk reduction of low-dose-aspirin-associated peptic ulcer disease.2
An NDA for a new formulation of ondansetron, as an orally dissolving film strip, has been submitted to the FDA.3 The product has shown comparable bioequivalence to ondansetron (Zofran) as an anti-emetic for preventing chemotherapy-induced nausea and vomiting, nausea and vomiting associated with radiotherapy, and post-operative nausea and vomiting.
An NDA for tesamorelin to treat HIV-lipodystrophy has been submitted to the FDA.4
Acarbose 25-, 50- and 100-mg tablets (generic precose)5
New Drugs, Indications and Dosage Forms
Artemether and lumefantrine (Coartem) tablets have been approved by the FDA for the treatment of acute, uncomplicated malarial infections in adults and children who weigh at least 5 kg.7 Coartem should be taken with food, particularly food that contains fat, because it improves drug absorption. Common adverse effects include headache, anorexia, dizziness, asthenia, arthralgia, and myalgia.
Besifloxacin 0.6% (Besivance) ophthalmic suspension has been approved by the FDA to treat bacterial conjunctivitis. Adverse effects include eye redness, blurred vision, eye pain, irritation, itching, and headache.8
Dexamethasone intravitreal implant (Ozurdex) has been approved by the FDA for treating macular edema following branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO).9 The implant is biodegradable and delivers dexamethasone via an extended-release mechanism over one to three months. Ozurdex is administered as an in-office procedure and is expected to be available soon.
Dronedarone (Multaq) tablets have been approved by the FDA as an antiarrhythmic agent.10 It is indicated to reduce the risk of cardiovascular hospitalization in patients with atrial flutter, or paroxysmal or persistent atrial fibrillation, with a recent episode of atrial fibrillation/atrial flutter and associated cardiovascular risk, who are in sinus rhythm or who will be cardioverted.11 Risk factors include age >70, hypertension, diabetes, prior cerebrovascular accident, a left atrial diameter ≥50 mm, and left ventricular ejection fraction [LVEF] <40%.
Hyoscyamine sulfate (NuLev) chewable antispasmodic orally disintegrating tablets (0.125 mg) have been reintroduced and are available to treat patients age 2 and older with gastrointestinal spasticity disorders.12
Lacosamide (Vimpat) has been approved by the FDA for add-on therapy in the treatment of partial-onset seizures in epilepsy patients age 17 and older.13
Lamotrigine extended-release (Lamictal XR) has been approved by the FDA as a once-daily add-on therapy for partial-onset seizures in epilepsy patients age 13 and older.14
Pioglitazone/metformin (ACTOplus met XR) combination tablets have been approved by the FDA for treating Type 2 diabetes.15 It should be available later this year.
Risperidone (Risperdal Consta) has received additional FDA approval as a biweekly injection as monotherapy, and as adjunctive therapy to lithium or valproate, in the maintenance of bipolar I disorder.16
Tadalafil (Adcirc) has been approved by the FDA for improving exercise ability in patients with pulmonary arterial hypertension (PAH).17 Tadalafil already is approved as brand-name Cialis for treating erectile dysfunction. Tadalafil is the first once-daily phosphodiesterase type-5 inhibitor for treating PAH, and it is hoped it will gain some of the sildenafil (Revatio) market.