The FDA has approved the monoamine oxidase type B (MAO-B) inhibitor safinamide (Xadago – US Worldmeds) as an adjunct to levodopa/carbidopa for management of "off" episodes in patients with Parkinson’s disease (PD). It is the first reversible MAO-B inhibitor to be approved for this indication. Selegiline (Eldepryl, and others) and rasagiline (Azilect, and generics), two irreversible MAO-B inhibitors, have been used alone and as adjuncts to levodopa/carbidopa for many years. Safinamide is not approved for use as monotherapy.

When used for the appropriate seizure type, antiseizure medications (ASMs) are roughly equivalent in efficacy. In addition to the seizure type, the choice of drug is usually based on factors such as ease of use, spectrum of activity, adverse effects, interactions with other drugs, presence of comorbid conditions, suitability for elderly persons and those with childbearing potential, and cost. Treatment should begin with a single drug, increasing the dosage gradually until seizures are controlled or adverse effects become unacceptable. If seizures persist, expert clinicians generally...

Sparfloxacin (Zagam - Rh ne-Poulenc Rorer) and levofloxacin (Levaquin - Ortho-McNeil) are the newest fluoroquinolone antimicrobials to be approved by the US Food and Drug Administration. Sparfloxacin in a once-daily oral preparation is being marketed for treatment of community-acquired pneumonia and acute bacterial exacerbations of chronic bronchitis. Levofloxacin, which is the active stereoisomer of ofloxacin (Floxin), is available for either oral or parenteral use; it is approved for oncedaily treatment of community-acquired pneumonia, acute exacerbations of chronic bronchitis,...

Esomeprazole magnesium (Nexium - AstraZeneca), the S-isomer of omeprazole (Prilosec), is the fifth benzimidazole proton pump inhibitor to become available in the United States. Omeprazole, which was the first, is going off patent this year.

Implanon (Organon), an implantable contraceptive containing the progestin etonogestrel, has been approved by the FDA. Two other implantable contraceptives, Norplant and Jadelle, which both contain levonorgestrel, are FDA-approved but not marketed in the US.

The FDA has approved artemether-lumefantrine (Coartem - Novartis) for oral treatment of uncomplicated Plasmodium falciparum malaria. It is not approved for prophylaxis. Artemether-lumefantrine is the first artemisinin-based drug approved for use in the US. Artemisinins are Chinese herbal products used worldwide to treat malaria. The intravenous formulation of artesunate, another artemisinin, is available in the US through the CDC.

The FDA has approved Gimoti (Evoke), a nasal spray formulation of the dopamine-2 (D₂) receptor antagonist metoclopramide, for relief of symptoms in adults with acute and recurrent diabetic gastroparesis. Metoclopramide (Reglan, and generics) has been available for years in conventional and orally-disintegrating tablets and in an injectable formulation. It is the only drug that is FDA-approved for treatment of diabetic gastroparesis.

The FDA has approved Relyvrio (Amylyx), a fixed-dose combination of sodium phenylbutyrate and taurursodiol, for treatment of amyotrophic lateral sclerosis (ALS). Sodium phenylbutyrate (Buphenyl, and others) has been available by prescription for years for treatment of urea cycle disorders. Taurursodiol (tauroursodeoxycholic acid), a derivative of ursodiol, is an over-the-counter bile acid supplement claimed to have neuroprotective benefits. Relyvrio is the third drug to be approved in the US for treatment of ALS; riluzole (Rilutek, and others) and edaravone (Radicava, Radicava...

The FDA has approved ritlecitinib (Litfulo – Pfizer), an oral JAK and TEC kinase family inhibitor, for treatment of severe alopecia areata in patients ≥12 years old. Ritlecitinib is the second oral drug to be approved in the US for treatment of severe alopecia areata; baricitinib (Olumiant), a JAK inhibitor, is approved only for use in adults.

Tipranavir (Aptivus - Boehringer Ingelheim), a new protease inhibitor, has received accelerated approval from the FDA. It must be given with ritonavir (Norvir). The combination is indicated for use with other antiretrovirals to treat HIV infection in highly treatment-experienced adults who have ongoing viral replication or in those with HIV strains known to be resistant to multiple protease inhibitors.