The oral cyclin-dependent kinase (CDK) 4/6 inhibitor ribociclib (Kisqali – Novartis) has been approved by the FDA for use in combination with an aromatase inhibitor for first-line endocrine-based therapy in postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer. Ribociclib is also available copackaged with the aromatase inhibitor letrozole (Femara, and generics) as Kisqali Femara Co-Pack. Ribociclib is the second CDK 4/6 inhibitor to be approved in the US for this indication;...

The FDA has approved an oral powder formulation of the amino acid L-glutamine (Endari – Emmaus) to reduce the acute complications of sickle cell disease in patients ≥5 years old. Endari is only the second drug to be approved for use in sickle cell disease; the antimetabolite hydroxyurea (Droxia) was approved 20 years ago. L-glutamine oral powder is also available by prescription as NutreStore for treatment of short bowel syndrome and over the counter as a dietary supplement.

The oral kinase inhibitors selpercatinib (Retevmo – Lilly) and pralsetinib (Gavreto – Blueprint Medicines/Genentech) have been approved by the FDA for treatment of advanced or metastatic RET-mutant or RET fusion-positive cancers. They are the first drugs to be approved specifically for certain RET-driven cancers. Both drugs were granted accelerated approval based on overall response rates and the duration of response.

Resmetirom (Rezdiffra – Madrigal), a thyroid hormone receptor-beta agonist, has received accelerated approval from the FDA for treatment of noncirrhotic nonalcoholic steatohepatitis (NASH) with moderate to advanced fibrosis in adults. NASH has recently been renamed metabolic dysfunction-associated steatohepatitis (MASH). Resmetirom is the first drug to be approved in the US for this indication.

Acesulfame potassium (Sunette - Hoechst), an oxathiazinondioxide, was recently approved by the US Food and Drug Administration (FDA) for use as a non-caloric table-top sweetener and as an ingredient in chewing gum, powdered beverages, gelatins and puddings. The other non-caloric artificial sweeteners available in the USA are saccharin (Sweet 'N Low; and others) and aspartame (NutraSweet; Equal) (Medical Letter, 24:1, 1982).

Tiopronin (Thiola - Mission), a thiol compound (mercaptopropionyl glycine) that solubilizes cystine by reacting with it to form a mixed disulfide, is now available in the USA for treatment of refractory cystinuria.

The 1990 labeling for Norpramin, the Merrell Dow brand of the tricyclic antidepressant desipramine, reports the occurrence of sudden death in an eight-year-old child treated with the drug. Desipramine is also available as Pertofrane (Rorer) and generically.

Breathe Right, an adhesive bandage device that pulls open the nostrils, has been approved by the US Food and Drug Administration and is being heavily promoted to the general public as a treatment for snoring and night-time nasal congestion. The manufacturer's suggested retail price is $4.99 for a box of 10 strips.

The FDA has approved peginterferon alfa-2b (Sylatron – Merck) for adjuvant treatment of node-positive melanoma after surgical resection. Pegylated interferon has a longer duration of action than interferon alfa-2b (Intron A), which is also FDA-approved for adjuvant treatment of malignant melanoma after surgery, and can be given once a week, compared to 3-5 times a week for standard interferon.

Recent reports indicate that intramuscular (IM) injection of the nonsteroidal anti-inflammatory drug (NSAID) ketorolac (Toradol, and others), sometimes directly into injured muscles, has become a common practice in US locker rooms.