The FDA has approved ofatumumab (Arzerra – GlaxoSmithKline), a human anti-CD20 monoclonal antibody, for treatment of patients with chronic lymphocytic leukemia (CLL) refractory to fludarabine (Fludara, and others) and alemtuzumab (Campath). It is the second anti-CD20 antibody approved for treatment of CLL; rituximab (Rituxan), a chimeric murine/human antibody, was the first.

The FDA has approved an extended-release oral formulation of the opioid agonist hydrocodone (Zohydro ER – Zogenix) for management of pain severe enough to require continuous, long-term therapy and for which alternative treatment options are inadequate. Zohydro ER is the first single-ingredient hydrocodone product to be marketed in the US. Hydrocodone has been available for years in combination with acetaminophen (Vicodin, and others) or ibuprofen (Vicoprofen, and others).

The FDA has approved Enstilar (Leo), an aerosol foam formulation of the synthetic vitamin D₃ analog calcipotriene and the high-potency corticosteroid betamethasone dipropionate, for topical treatment of plaque psoriasis in adults. Topical ointment and suspension formulations of the same combination have been available for many years.

The FDA has approved anthrax vaccine adsorbed (AVA; BioThrax – Emergent BioSolutions) for prevention of anthrax disease in adults following exposure to Bacillus anthracis and intravenous anthrax immune globulin (Anthrasil – Emergent BioSolutions) for treatment of inhalation anthrax in adults and children. AVA has been available since 1970 for prevention of anthrax disease in persons at high risk of exposure.

The FDA has approved Cardamyst (Milestone), a nasal spray formulation of the nondihydropyridine calcium channel blocker etripamil, for conversion of acute symptomatic episodes of paroxysmal supraventricular tachycardia (PSVT) to sinus rhythm in adults. Cardamyst is the first product containing etripamil to be approved in the US. It is being marketed as the only FDA-approved, self-administered, rapid-acting treatment option for acute episodes of PSVT.

The angiotensin-converting enzyme (ACE) inhibitors captopril (Capoten - Squibb) and enalapril (Vasotec - Merck) are now widely used to treat chronic congestive heart failure that has not responded adequately to digitalis and diuretics (Medical Letter, 30:13, Jan 29, 1988). Recently, some cardiologists have debated whether ACE inhibitors should also be used as first-line agents for treatment of this condition (WW Parmley et al, J Am Coll Cardiol, 12:265, July 1988).

Three benzodiazepines and 16 other compounds are marketed in the USA for treatment of insomnia. Many authorities believe that insomnia is overdiagnosed and overtreated (MK Erman, ed, Sleep Disorders, Psychiatr Clin North Am, Volume 10, Dec 1987).

Carboplatin (Paraplatin - Bristol-Myers), a cytotoxic platinum-containing drug chemically related to cisplatin (Platinol), was recently approved by the US Food and Drug Administration (FDA) for palliative treatment of patients with recurrent ovarian cancer, including those previously treated with cisplatin.

Since the implication of aspirin in Reye's syndrome, acetaminophen (Tylenol; and others) has become the standard drug for symptomatic treatment of fever and pain in children. Ibuprofen, a nonsteroidal anti-inflammatory drug (NSAID) available for many years in tables (Mortin; Advil; and others), has now become available in a suspension. The suspension will be sold by presecription for treatment of fever or arthritis in children.

Benazepril (Lotensin - Ciba-Geigy), fosinopril (Monopril - Mead Johnson), and - Hoechst, Upjohn) are new angiotensin-converting enzyme (ACE) inhibitors recently approved by the US Food and Drug Administration (FDA) for once-a-day treatment of hypertension. Three other ACE inhibitors, captopril (Capoten), enalapril (Vasotec), and lisinopril (Prinivil, Zestril) were previously available in the USA for this indication. Captopril and enalapril have also been approved by the FDA for treatment of congestive heart failure.