The FDA has recently approved intradetrusor injection of onabotulinumtoxinA (Botox – Allergan) for treatment of overactive bladder in patients who cannot tolerate or have an inadequate response to anticholinergic therapy. Botox is also approved by the FDA for use in detrusor overactivity associated with a neurologic condition such as multiple sclerosis or spinal cord injury, and for chronic migraine, upper limb spasticity, axillary hyperhidrosis, cervical dystonia, blepharospasm, strabismus, and cosmetic reduction of wrinkles.

The FDA has approved injection of onabotulinumtoxinA (Botox – Allergan) for prevention of headaches in adult patients with chronic migraine (≥15 headache days/month for ≥3 months). It is the first drug approved for treatment of this indication. Botox is also FDA-approved for treatment of upper limb spasticity, axillary hyperhidrosis, cervical dystonia, blepharospasm and strabismus, and for cosmetic reduction of wrinkles.

The FDA has approved prabotulinumtoxinA-xvfs (Jeuveau – Evolus) for temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity. Jeuveau is the fourth botulinum toxin product to be approved in the US for this indication (see Table 1). It has been available in South Korea as Nabota since 2014.

Qbrexza (Dermira), a premoistened cloth containing the long-acting anticholinergic drug glycopyrronium, has been approved by the FDA for once-daily topical treatment of excessive underarm sweating (primary axillary hyperhidrosis) in patients ≥9 years old. Glycopyrronium bromide (glycopyrrolate) has been available for years in parenteral, inhalation, and oral formulations for treatment of multiple conditions.

In overactive bladder, involuntary bladder contractions due to detrusor overactivity result in urinary urgency, frequency, nocturia, and incontinence. The prevalence of the disorder increases with age. Nonpharmacologic treatment, including bladder training, urge suppression, pelvic floor muscle exercises, constipation management, modification of fluid intake, and avoidance of dietary irritants such as alcohol and caffeine, should be tried first.

Brella Sweat Control Patch (Candesant Biomedical), a sodium-containing transdermal patch, has been cleared by the FDA for in-office treatment of primary axillary hyperhidrosis in adults. It is the first patch to be approved in the US for this indication.

The FDA has approved erenumab-aooe (Aimovig – Amgen/Novartis), a once-monthly, subcutaneously-injected, monoclonal antibody against the calcitonin gene-related peptide receptor, for preventive treatment of migraine in adults. It is the first drug in its class to be approved by the FDA.

The FDA has approved daxibotulinumtoxinA-lanm (Daxxify – Revance), an acetylcholine release inhibitor and neuromuscular blocking agent, for temporary improvement in the appearance of moderate to severe glabellar (frown) lines associated with corrugator and/or procerus muscle activity. Daxxify is the fifth botulinumtoxin type A product to be approved in the US for this indication (see Table 1). It is also approved for treatment of cervical dystonia in adults

The FDA has approved a 12.45% gel formulation of the anticholinergic drug sofpironium (Sofdra – Botanix) for treatment of primary axillary hyperhidrosis (excessive underarm sweating) in patients ≥9 years old.

The FDA has approved two subcutaneously injected calcitonin gene-related peptide (CGRP) antagonists, fremanezumab-vfrm (Ajovy – Teva) and galcanezumab-gnlm (Emgality – Lilly), for migraine prevention in adults. Fremanezumab and galcanezumab are the second and third subcutaneously injected monoclonal antibodies that target the CGRP pathway to be approved by the FDA for this indication; erenumab-aooe (Aimovig), which targets the CGRP receptor, was the first.