Rofecoxib, a selective COX-2 inhibitor, has been approved by the FDA for treatment of osteoarthritis, acute pain and menstrual pain.

Teriparatide (ter i par' a tide; Forteo - Lilly), a recombinant segment of human parathyroid hormone, has been approved by the FDA for parenteral treatment of osteoporosis in post-menopausal women, and in men with idiopathic or hypogonadal osteoporosis, who are at high risk for fracture. Teriparatide is the first approved treatment for osteoporosis that stimulates bone formation. Other drugs approved for this indication inhibit bone resorption (Treatment Guidelines from the Medical Letter 2002;1:13).

Montelukast (Singulair - Merck), a leukotriene receptor antagonist already marketed for asthma (Treatment Guidelines from The Medical Letter 2002; 1:11), has been approved by the FDA for treatment of seasonal allergic rhinitis in adults and children more than 2 years old.

Levalbuterol, the R-isomer of the beta-2 adrenergic agonist albuterol, is now available in the US as a metered-dose inhaler (Xopenex HFA - Sepracor) for treatment of asthma in patients ≥ 4 years old. Levalbuterol has been available since 1999 in a nebulizer solution for treatment of bronchospasm in patients ≥ 6 years old.1 Outside the US, albuterol is called salbutamol, and levalbuterol is levosalbutamol.

Bupropion (Wellbutrin - GlaxoSmithKline, and others) is a norepinephrine and dopamine reuptake inhibitor that has been a useful antidepressant because, unlike some other antidepressants, it does not cause sexual dysfunction, weight gain or sedation. Some patients who were switched from Wellbutrin to a generic alternative have reported worsening side effects and relapse of previously controlled depressive symptoms.1 Most of the complaints have come from patients switched from Wellbutrin XL 300 mg to the generic 300-mg formulation of extended-release bupropion marketed by Teva (Budeprion XL).2...

The FDA has approved the use of recombinant human antithrombin (rhAT; ATryn - Lundbeck) in patients with inherited antithrombin (AT) deficiency to prevent thrombosis during or after surgery or childbirth. The protein is produced in the milk of transgenic goats carrying a copy of the human cDNA for AT. This is the first US drug approval for a protein produced by a transgenic animal. ATryn has been used in Europe since 2006.

L-methylfolate (Deplin — Pamlab) is a “medical food” marketed for adjunctive use in depression or schizophrenia in patients with suboptimal folate levels. It is available only by prescription.

The FDA has approved ceftaroline fosamil (Teflaro – Forest), an intravenous (IV) cephalosporin, for treatment of acute bacterial skin and skin structure infections, including those caused by methicillin-resistant Staphylococcus aureus (MRSA), and for treatment of community-acquired bacterial pneumonia in adults. It is the first beta-lactam antibiotic approved for treatment of MRSA.

The FDA has approved dolutegravir (doll-you-TEG-rah-veer; Tivicay – Viiv Healthcare), an integrase strand transfer inhibitor (INSTI), for treatment of HIV-1 infection in adults and in children ≥12 years old who weigh at least 40 kg. It is the third INSTI to be approved by the FDA; raltegravir and elvitegravir were approved earlier.

Rifaximin (Xifaxan – Salix), a minimally absorbed oral antibiotic approved previously to treat travelers' diarrhea and to reduce the risk of recurrent hepatic encephalopathy, has now been approved by the FDA for treatment of irritable bowel syndrome with diarrhea (IBS-D). Eluxadoline (Viberzi – Actavis), a mu-opioid receptor agonist, was also recently approved for IBS-D and will be reviewed in a future issue.