Axona (Accera), a "medical food" containing a proprietary formulation of medium-chain triglycerides (>95% caprylic triglyceride), is currently being marketed for the "clinical dietary management of the metabolic processes associated with mild to moderate Alzheimer's disease."

Mirabegron (mir a beg’ ron; Myrbetriq [meer BEH trick] – Astellas), a beta-3 adrenergic agonist, has been approved by the FDA for the treatment of overactive bladder. It is the first beta-3 adrenergic agonist to be approved for any indication in the US. Mirabegron has been marketed in Japan since 2011. OnabotulinumtoxinA (Botox) was also recently approved by the FDA for treatment of overactive bladder and will be reviewed in a future issue.

The FDA has approved the mitogen-activated extracellular signal-regulated kinase (MEK) inhibitor cobimetinib (Cotellic – Genentech) for use in combination with the BRAF kinase inhibitor vemurafenib (Zelboraf) for treatment of unresectable or metastatic melanoma with a BRAF V600E or V600K mutation.

Butorphanol tartrate, a synthetic opioid agonist-antagonist analgesic previously available for injection, is now being marketed as a nasal spray (Stadol-NS - Mead Johnson). The spray was approved by the US Food and Drug Administration (FDA) for any type of pain for which an opioid analgesic is appropriate, but the manufacturer is emphasizing use for treatment of migraine headache and postoperative pain. Drugs for pain were reviewed in the Medical Letter, volume 35, page 1, January 8, 1993.

A 0.05% ophthalmic solution of levocabastine hydrochloride (Livostin - Iolab), a histamine H 1 -receptor antagonist, has been approved by the US Food and Drug Administration for treatment of seasonal allergic conjunctivitis. The new drug is a cyclohexylpiperidine derivative with no structural relationship to any other antihistamine.

Anastrozole (Arimidex - Zeneca), a selective nonsteroidal aromatase inhibitor, has been approved by the US Food and Drug Administration (FDA) for treatment of postmenopausal women with advanced breast cancer that has progressed during treatment with tamoxifen (Nolvadex, and others).

The FDA has approved the use of dalfampridine (4-aminopyridine; Ampyra – Acorda), a potassium channel blocker, to improve walking speed in patients with multiple sclerosis (MS). Walking speed is considered a reliable clinical measure of impairment in patients with MS.

The FDA has approved a buccal tablet formulation of miconazole (Oravig – Strativa) for local treatment of oropharyngeal candidiasis in adults. Miconazole has been available for many years in topical formulations for treatment of superficial fungal infections and vulvovaginal candidiasis.

The FDA recently approved vandetanib [van det´ a nib] (Caprelsa – AstraZeneca) for oral treatment of symptomatic or progressive medullary thyroid cancer (MTC) in patients with unresectable locally advanced or metastatic disease. Vandetanib is the first drug approved in the US for medullary thyroid cancer.

The oral kinase inhibitor tucatinib (Tukysa – Seagen) has received accelerated approval from the FDA for use in combination with trastuzumab (Herceptin) for treatment of adults with RAS wild-type human epidermal growth factor receptor 2 (HER2)-positive unresectable or metastatic colorectal cancer that has progressed following treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy regimens. Tucatinib was approved in 2020 for use in combination with trastuzumab and capecitabine (Xeloda, and generics) for treatment of adults with advanced unresectable or...