Belotero Balance (Merz), an injectable hyaluronic acid dermal filler, has been approved by the FDA for temporary correction of moderate-to-severe facial wrinkles and folds. Several other hyaluronic acid products are also available for this indication (e.g., Restylane, Perlane, Juvéderm). They have supplanted bovine collagen products, which persist for a shorter time and cause more allergic reactions.

The FDA has approved asfotase alfa (Strensiq – Alexion), a recombinant form of tissue-nonspecific alkaline phosphatase, for subcutaneous treatment of perinatal-, infantile-, and juvenile-onset hypophosphatasia. Asfotase alfa is the first treatment to be approved in the US for this rare genetic metabolic disorder.

The FDA has approved Erzofri (Luye), an extended-release injectable formulation of the second-generation antipsychotic drug paliperidone palmitate, for treatment of schizophrenia and schizoaffective disorder in adults. It is the second once-monthly formulation of paliperidone palmitate to be approved in the US for these indications; Invega Sustenna was the first. Longer-acting injectable formulations of paliperidone palmitate are also available (see Table 1).

The FDA has approved changes to the labeling of Sublocade (Indivior), an extended-release formulation of the partial opioid agonist buprenorphine, to permit faster initiation and use of alternative injection sites. Sublocade is indicated for once-monthly subcutaneous treatment of moderate to severe opioid use disorder.

Until the recent introduction of febuxostat (Uloric), no new drugs had been marketed for treatment of gout in the past 40 years. Colchicine, which has been available for decades as an unapproved drug, has now been approved by the FDA (Colcrys) for treatment and prophylaxis of gout flares. It was approved earlier only in combination with probenecid (Colbenemid, and others). The goals of gout treatment are three-fold: treating acute disease, preventing flares and reducing uric acid stores.

Endoscopic injection of sclerosing agents is now widely accepted as a primary treatment for bleeding esophageal varices (J Terblanche et al, N Engl J Med, 320:1393, 1469, May 25 and June 1, 1989). Ethanolamine oleate 5% (Ethamolin - Glaxo), a sclerosing agent that has been available in Canada and abroad for many years, was recently approved for this indication by the US Food and Drug Administration (FDA).

Recombinant alpha interferon has been marketed in the USA for treatment of hairy-cell leukemia, genital warts, and AIDS-related Kaposi's sarcoma (Medical Letter, 28:78, 1986; 30:70, 1988). Recent reports indicate it may also be useful for treatment of chronic viral hepatitis. Recombinant alpha interferon is available as alfa-2a (Roferon-A - Roche) or alfa-2b (Intron A - Schering), which are identical except for one amino acid.

An intranasal formulation of the corticosteroid triamcinolone (Nasacort - Rh ne- Poulenc Rorer) was recently approved by the US Food and Drug Administration for once-daily treatment of seasonal and perennial allergic rhinitis.

Atovaquone (Mepron - Burroughs Wellcome), a hydroxynaphthoquinone, was recently approved by the US Food and Drug Administration (FDA) for oral treatment of mild to moderate Pneumocystis carinii pneumonia (PCP) in patients who cannot tolerate trimethoprim-sulfamethoxazole (Septra, Bactrim, and others). PCP is a common opportunistic infection and frequent cause of death in patients with AIDS.

The US Food and Drug Administration has approved use of the angiotensin-converting enzyme (ACE) inhibitor captopril (Capoten) for patients with left ventricular dysfunction after a myocardial infarction. ACE inhibitors, widely used for treatment of hypertension, in recent years have also been used for treatment of heart failure (Medical Letter, 35:40, 1993).