The FDA has approved the marketing of fingolimod (Gilenya – Novartis) to reduce the frequency of clinical exacerbations and delay the accumulation of physical disability in patients with relapsing forms of multiple sclerosis (MS). Fingolimod is the first oral drug approved for this indication.

Belbuca (Endo), a buccal formulation of the partial opioid agonist buprenorphine, has been approved by the FDA for management of pain severe enough to require daily, around-the-clock, long-term opioid treatment. Buprenorphine is also available as a transdermal patch (Butrans) and in a parenteral formulation (Buprenex, and generics) for treatment of pain. A sublingual formulation of buprenorphine and buccal and sublingual formulations containing buprenorphine and the opioid antagonist naloxone are approved for use as alternatives to methadone for treatment of opioid...

The FDA has approved the fully human monoclonal antibody bezlotoxumab (Zinplava – Merck) for use with antibacterial drug treatment to reduce recurrence of Clostridium difficile infection (CDI) in adults with CDI at high risk for recurrence. It is the first drug to be approved for this indication.

The FDA has approved valbenazine (Ingrezza – Neurocrine Biosciences), a vesicular monoamine transporter 2 (VMAT2) inhibitor, for treatment of tardive dyskinesia in adults. It is the first drug to be approved in the US for this indication; two other VMAT2 inhibitors, tetrabenazine (Xenazine, and generics) and deutetrabenazine (Austedo), were approved earlier for treatment of chorea associated with Huntington's disease.

The FDA has approved an estradiol softgel vaginal insert (Imvexxy – TherapeuticsMD) for treatment of postmenopausal women with moderate to severe dyspareunia due to vulvovaginal atrophy (VVA). Imvexxy is the second estradiol vaginal insert to be approved in the US; Vagifem, an intravaginal tablet formulation, was the first. Vagifem and Imvexxy are both available in inserts containing 10 mcg of estradiol; Imvexxy is also available in a 4-mcg strength.

On February 27, 2021, the FDA issued an Emergency Use Authorization (EUA) for the Johnson & Johnson adenovirus-based vaccine for prevention of COVID-19 in persons ≥18 years old. It is the third COVID-19 vaccine to become available in the US and the first to require only a single dose. Two-dose mRNA-based vaccines manufactured by Pfizer-BioNTech and Moderna received EUAs in December 2020.

The FDA has approved the complement C5 inhibitor avacincaptad pegol (Izervay – Iveric) for intravitreal treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD). Avacincaptad pegol is the second complement inhibitor to be approved in the US for this indication; pegcetacoplan (Syfovre), a complement C3 and C3b inhibitor, was approved earlier.

Many patients ask physicians to help them stop smoking. Since nicotine gum and patches were first marketed (Medical Letter, 26:47, 1984; 34:37, 1992), more data have become available on their effective use, and new formulations of the drug have been developed. Because of its slower rate of absorption, nicotine from gum or patches does not produce the pleasure some people associate with cigarette smoking, but it can relieve the irritability, difficulty in concentrating and other symptoms that occur after withdrawal from smoking.

The FDA has approved use of gamma hydroxybutyrate (sodium oxybate is the official generic name; Xyrem - Orphan Medical) for oral treatment of cataplexy in patients with narcolepsy. Gamma hydroxybutyrate (GHB), a metabolite of gamma-aminobutyric acid (GABA), is a central-nervous-system depressant marketed in Europe for use in general anesthesia. In recent years it has been notorious for its use in "date-rape" (Medical Letter 2002; 44:21). Xyrem is a Schedule III controlled substance.

The nonsteroidal anti-inflammatory drug (NSAID) diclofenac, has been approved by the FDA in a 1% topical gel formulation (Voltaren Gel - Endo) for treatment of osteoarthritis (OA). A 3% topical diclofenac gel (Solaraze) is currently approved for treatment of actinic keratoses, but not for topical use on joints. No other topical NSAIDs are approved by the FDA for OA. A diclofenac patch (Flector) was recently approved by the FDA for treatment of pain due to minor strains, sprains and contusions.