Poractant alfa intratracheal suspension (Curosurf), a formulation of surfactant available in Europe since 1989, has been approved by the FDA for treatment of neonatal respiratory distress syndrome (RDS).

Recombinant interferon alfa-2b conjugated to polyethylene glycol (PEG-Intron), the first "pegylated"alpha interferon, has been approved by the FDA for once-a-week monotherapy of chronic hepatitis C virus (HCV) infection in patients not previously treated with alpha interferon.

View the Comparison Table: H2-Receptor Antagonists and PPIs

Miudella (Sebela), a copper intrauterine device (IUD), has been approved by the FDA for prevention of pregnancy for up to 3 years. Miudella is the second copper IUD to be approved in the US; ParaGard, which contains more copper and is approved for up to 10 years of use, was approved in 1984. Four hormonal IUDs (Mirena, Liletta, Skyla, Kyleena) that release the progestin levonorgestrel are also available for pregnancy prevention (see Table 2).

The FDA has approved vonoprazan, a potassium-competitive acid blocker, copackaged with amoxicillin (Voquezna Dual Pak – Phathom) and with amoxicillin and clarithromycin (Voquezna Triple Pak) for treatment of Helicobacter pylori infection in adults. Vonoprazan is the first potassium-competitive acid blocker to be approved in the US. It has been available in Japan for treatment of various acid-related disorders since 2014. Vonoprazan is not available alone in the US.

The FDA has authorized two manufacturers (Teva, Mylan) to market generic formulations of celecoxib (Celebrex – Pfizer), the only COX-2 selective inhibitor remaining on the US market. Celecoxib is less likely than nonselective NSAIDs to cause gastric ulcers or other GI toxicity,1 and unlike traditional NSAIDs, it does not have an antiplatelet effect.Celecoxib is much less COX-2 selective than rofecoxib (Vioxx), which was removed from the US market because of an increased risk of cardiovascular events. One analysis of randomized clinical trials that included a total of about 26,000 patients...

Ertapenem (er ta pen' em; Invanz - Merck), a carbapenem antibacterial with a narrower spectrum of activity than imipenem (Primaxin) or meropenem (Merrem), has been approved by the FDA for once-daily IV treatment of complicated intra-abdominal, urinary tract and skin and skin structure infections, acute pelvic infections, and community-acquired pneumonia.

Bosentan (Tracleer - Actelion), a non-peptide endothelin receptor antagonist, has been approved by the FDA for oral treatment of patients who have pulmonary arterial hypertension (PAH) with symptoms of dyspnea at rest or with minimal exertion.

Tiotropium bromide inhalation powder (Spiriva HandiHaler - Boehringer Ingelheim), a long-acting anticholinergic agent, has been approved by the FDA for once-daily maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD). Available in Europe since 2002, it is the first long-acting inhaled anticholinergic drug for treatment of COPD. Ipratropium bromide (Atrovent), an anticholinergic used four times daily, has been available in the US for many years.

The FDA has approved an oral, fixed-dose combination (Treximet - GlaxoSmithKline) of the selective serotonin receptor agonist ("triptan") sumatriptan (Imitrex) and the nonsteroidal anti-inflammatory drug (NSAID) naproxen sodium (Anaprox, and others) for acute treatment of migraine attacks.