The FDA recently approved the proton pump inhibitor omeprazole magnesium (Prilosec OTC) for over-the-counter use for treatment of frequent heartburn. It will be marketed in late September or early October. Five proton pump inhibitors, including omeprazole, are available by prescription in the US (Medical Letter 2001; 43:36).

An orally dissolving, immediate-release tablet formulation of carbidopa/levodopa (Parcopa - Schwarz) that can be taken without water is now available for treatment of Parkinson's disease.

The FDA has approved Duexis (Horizon), a fixed-dose combination of the nonsteroidal anti-inflammatory drug (NSAID) ibuprofen and the H2-receptor antagonist (H2RA) famotidine, for symptomatic relief of osteoarthritis and rheumatoid arthritis and to decrease the risk of developing gastric and duodenal ulcers in patients at risk for NSAID-associated ulcers. Vimovo, a combination of the NSAID naproxen and the proton pump inhibitor (PPI) esomeprazole, is also approved by the FDA for prevention of NSAID-associated gastric ulcers.

The FDA has approved deferiprone (de fer’ i prone; Ferriprox – ApoPharma), an oral chelating agent available in Europe since 1999, for use as a second-line treatment of iron overload due to blood transfusions (transfusional hemosiderosis) in patients with thalassemia. Two other iron chelating agents, deferoxamine (Desferal, and others), which is usually administered subcutaneously, and oral deferasirox (Exjade), are available for use as first-line therapy in the US.

The FDA has approved use of lubiprostone (Amitiza) for treatment of opioid-induced constipation in adults with chronic non-cancer pain. The drug was previously approved for chronic idiopathic constipation and irritable bowel syndrome with constipation.

The FDA has approved the oral multikinase inhibitor lenvatinib (Lenvima – Eisai) for treatment of locally recurrent or metastatic, progressive, differentiated thyroid cancer (papillary or follicular) refractory to radioactive iodine treatment.

The FDA has approved the ReShape Integrated Dual Balloon System (ReShape Medical) and the Orbera Intragastric Balloon System (Apollo Endosurgery) for up to 6 months of use in adults with a BMI of 30-40 who have not been able to maintain weight loss with a weight loss program and, for ReShape, who have at least one obesity-related comorbidity. Both devices have been available in the European Union and elsewhere for years (20 years for Orbera). Three other devices, the LAP-Band, the Realize adjustable gastric band, and the Maestro Rechargeable System, are FDA-approved for long-term...

The FDA has approved Ruconest (Salix), a recombinant analog of human complement component 1 esterase inhibitor (C1INH), for treatment of acute attacks in patients with hereditary angioedema (HAE).

The FDA has approved ferric pyrophosphate citrate solution (Triferic – Rockwell Medical) to maintain hemoglobin concentrations in adults with hemodialysis-dependent chronic kidney disease. Triferic is the first iron replacement product that is added into the hemodialysis solution at each dialysis procedure.

The FDA has approved an effervescent tablet formulation of acetylcysteine (Cetylev – Arbor) to prevent or lessen hepatic injury after acetaminophen overdose. Acetylcysteine has been available for years in an IV solution (Acetadote, and generics) and an oral solution for the same indication; use of the oral solution has been limited by its unpleasant odor and taste.