On January 3, the FDA amended its Emergency Use Authorization (EUA) for the Pfizer-BioNTech COVID-19 vaccine (Comirnaty) to incorporate the following changes. The anti-SARS-CoV-2 antibody combinations casirivimab plus imdevimab (REGEN-COV) and bamlanivimab plus etesevimab are not active against the Omicron variant of SARS-CoV-2.

Prademagene zamikeracel (Zevaskyn – Abeona Therapeutics), an autologous cell sheet-based gene therapy, has been approved by the FDA for treatment of wounds in patients with recessive dystrophic epidermolysis bullosa. It is the first autologous cell sheet-based gene therapy to be approved in the US for this indication. Beremagene geperpavek gel (Vyjuvek), a herpes simplex virus type 1 vector-based gene therapy, is approved for once-weekly use in patients ≥6 months old with recessive dystrophic epidermolysis bullosa.

The FDA has approved an oral tablet formulation of sodium sulfate, magnesium sulfate, and potassium chloride (Sutab – Braintree) for colon cleansing prior to colonoscopy in adults. A sodium sulfate-based oral solution (Suprep) has been available in the US since 2010. Sutab is the second tablet formulation to be approved for bowel cleansing prior to colonoscopy; a sodium phosphate-based tablet (OsmoPrep) was approved earlier.

Quazepam (Doral - Baker Cummins, Wallace) is a trifluoroethyl benzodiazepine made by Schering and approved in 1985 by the US Food and Drug Administration for treatment of insomnia. Like other benzodiazepines, it is a Schedule IV controlled substance.Quazepam (Doral - Baker Cummins, Wallace) is a trifluoroethyl benzodiazepine made by Schering and approved in 1985 by the US Food and Drug Administration for treatment of insomnia. Like other benzodiazepines, it is a Schedule IV controlled substance.

Pegaspargase (peg as par jase; PEG-L-asparaginase; Oncaspar - Rh ne-Poulenc Rorer), a polyethylene glycol (PEG) conjugate of L-asparaginase, has been approved by the US Food and Drug Administration for treatment of acute lymphoblastic leukemia (ALL), the most common malignancy of childhood. The new drug is recommended only for patients who have had allergic reactions to asparaginase. Asparaginase is available commercially as Elspar, which is derived from Escherichia coli. A formulation derived from Erwinia chrysanthemi is available on an investigational basis (Ogden Bioservices,...

Epoprostenol sodium (Flolan - Glaxo Wellcome), also known as prostacyclin, has been approved by the US Food and Drug Administration for continuous intravenous treatment of primary pulmonary hypertension.

Azelaic acid, a naturally occurring heptanedicarboxylic acid, has been marketed in the USA as a 20% cream (Azelex - Allergan) for treatment of acne. The drug has been available in Europe for several years.

Bicalutamide (Casodex - Zeneca), an oral nonsteroidal antiandrogen similar to flutamide (Eulexin - Medical Letter, 31:72, 1989), is now available in the USA for treat-ment of advanced prostate cancer. The drug is recommended by the manufacturer for use concurrently with an analog of luteinizing hormone-releasing hormone (LHRH) such as leuprolide (Lupron; Lupron Depot) or goserelin (Zoladex -Medical Letter, 32:102, 1990).

Interferon β-1a (Avonex - Biogen), a recombinant form of human interferon β, has been approved by the US Food and Drug Administration (FDA) for treatment of relapsing forms of multiple sclerosis (MS). Interferon β-1a (Betaseron - Berlex), a recombinant analog of interferon β that differs from interferon β-1a in having a serine substituted for a cysteine and in not being glycosylated, was previously approved for this indication (Medical Letter, 35:61, 1993; BW van Oosten et al, Drugs, 49:200, 1995).

Results of a recent study suggested that zinc gluconate may be effective in treating the common cold (SB Mossad et al, Ann Intern Med, 125:81, July 15, 1996). Zinc gluconate lozenges, sometimes combined with vitamin C or other ingredients, are available in pharmacies and health food stores throughout the USA.