Fulvestrant (Faslodex -- AstraZeneca), an estrogen receptor antagonist given intramuscularly (IM) once a month, was recently approved by the FDA for treatment of hormone-receptor-positive metastatic breast cancer in postmenopausal women with disease progession on tamoxifen (Nolvadex, and others) or another antiestrogen.

A new pentavalent vaccine (Pediarix - GlaxoSmithKline), licensed by the FDA for children 6 weeks to 7 years old, includes the antigens from vaccines already marketed against diphtheria, tetanus and pertussis (Infanrix) and hepatitis B (Engerix-B), and a new inactivated polio component.

Tegaserod maleate (teg a ser' od; Zelnorm - Novartis), a serotonin derivative, has received FDA approval for short-term treatment of women with irritable bowel syndrome (IBS) whose primary symptom is constipation. Alosetron (Lotronex), which was withdrawn previously because of toxicity, will soon be available again for women with severe diarrhea-predominant IBS (Medical Letter 2002; 44:67).

The FDA has approved recombinant interferon alfa-2a conjugated to polyethylene glycol (Pegasys - Roche) alone or with oral ribavirin (Copegus - Roche) for treatment of adults with chronic hepatitis C virus (HCV) infections not previously treated with interferon alpha. The standard of care for treatment of most patients with hepatitis C has been once-weekly injections of peginterferon alfa-2b (PEG-Intron -Schering) plus oral ribavirin (Rebetol - Schering) (Medical Letter 2001; 43:54).

The FDA has approved pegvisomant (Somavert Pfizer), a growth hormone receptor antagonist, for parenteral treatment of acromegaly in patients who are not candidates for or have had an inadequate response to surgery or other treatment. This review describes the disease of acromegaly and its standard treatment options. Also included are sections on the mechanism of action, pharmacokinetics, adverse effects, drug interactions, and the dosage and cost of pegvisomant. Results of clinical studies are discussed. The conclusion provides an overall assessment of the prospects for this new drug.

Fezolinetant (Veozah – Astellas), a first-in-class neurokinin 3 (NK3) receptor antagonist, has been approved by the FDA for treatment of moderate to severe vasomotor symptoms (VMS) due to menopause. It is the second nonhormonal treatment to be approved in the US for this indication; a low-dose formulation of the selective serotonin reuptake inhibitor (SSRI) paroxetine mesylate (Brisdelle) was approved in 2013.

Ketorolac (kee'; toe role ak) tromethamine (Toradol), manufactured by Syntex but also marketed by Roche, is the first parenteral nonsteroidal anti-inflammatory drug (NSAID) to become available for analgesic use in the USA. Parenteral indomethacin (Indocin I.V.) has been marketed here since 1985, but only for treatment of patent ductus arteriosus in newborn infants. Other parenteral NSAIDs are available in other parts of the world, but low potency, poor aqueous solubility, and substantial tissue irritation on injection have limited their usefulness. Ketorolac has been approved by the US ...

The physiologic changes that occur with aging can affect the pharmacokinetics and pharmacodynamics of many prescription and over-the-counter drugs, increasing the likelihood of adverse effects.

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 Cobenfy (BMS), an oral fixed-dose combination of the muscarinic agonist xanomeline and the peripheral muscarinic antagonist trospium chloride, for treatment of schizophrenia in adults. It is the first antipsychotic drug to be approved in the US for treatment of schizophrenia that does not block dopamine receptors. This is the first approval for xanomeline; trospium has been available for many years for treatment of overactive bladder.