Fluvoxamine (Luvox - Solvay), a selective serotonin reuptake inhibitor (SSRI), has been approved for treatment of obsessive-compulsive disorder (OCD) by the US Food and Drug Administration. Fluoxetine (Prozac), another SSRI antidepressant, and clomipramine (Anafranil), a tricyclic antidepressant that also inhibits serotonin reuptake, are the only other drugs available for this indication in the USA. Antidepressants that do not inhibit serotonin reuptake have not been effective for treatment of this condition.

Fexofenadine (fex oh fen' a deen) hydrochloride (Allegra - Hoechst Marion Roussel) has been approved by the US Food and Drug Administration for treatment of seasonal allergic rhinitis. An active metabolite of terfenadine, fexofenadine is being heavily advertised as "nonsedating...without 'black box' warnings."

High doses of estrogens, with or without a progestin, have been used for many years to prevent pregnancy after unprotected coitus (Medical Letter, 31:93, 1989). Now the FDA has approved marketing of the Preven Emergency Contraceptive Kit (Gynetics, Inc.) for this indication. The kit, which will require a prescription, includes four tablets, each containing 50 g of ethinyl estradiol and 0.25 mg of levonorgestrel, and a pregnancy test to rule out a pre-existing pregnancy, which would be a contraindication to taking the hormones.

The FDA has approved an extended-release formulation of clonidine hydrochloride (Kapvay– Shionogi) for treatment of attention-deficit/hyperactivity disorder (ADHD) in children 6-17 years old. It is the second alpha₂-adrenergic agonist approved for this indication; guanfacine hydrochloride (Intuniv) was the first, but only clonidine is approved for use with stimulants.

The FDA has approved belatacept (bel at´ a sept; Nulojix – Bristol-Myers Squibb) for prevention of organ rejection in adult patients receiving a kidney transplant.

The FDA has approved raxibacumab (rax” ee bak’ ue mab; GSK), a fully human monoclonal antibody given by intravenous infusion, for treatment of inhalational anthrax in combination with appropriate antibacterial drugs, and for prophylaxis of inhalational anthrax when alternative therapies are not available or are not appropriate. It was approved under the Animal Efficacy Rule, which allows the FDA to approve drugs that demonstrate efficacy in animals, providing that they would have a reasonable human health benefit and are safe for human use. Raxibacumab is only available from the...

The FDA has granted accelerated approval to copanlisib (Aliqopa – Bayer), an intravenously administered phosphatidylinositol 3-kinase (PI3K) inhibitor, for treatment of adults with relapsed follicular lymphoma who have received at least two prior systemic therapies. Follicular lymphoma is a common subtype of non-Hodgkin's lymphoma. Copanlisib is the second PI3K inhibitor to be approved for this indication; idelalisib (Zydelig), which is administered orally twice daily, was the first.

The FDA has approved a 6% otic suspension formulation of the fluoroquinolone antibiotic ciprofloxacin (Otiprio – Otonomy) for single-dose treatment of acute otitis externa (swimmer's ear) caused by Pseudomonas aeruginosa or Staphylococcus aureus in patients ≥6 months old. Otiprio was approved earlier for prophylaxis in children with bilateral otitis media with effusion who are undergoing tympanostomy tube placement.

The FDA has approved Trijardy XR (Boehringer Ingelheim/Lilly), a fixed-dose combination of the sodium-glucose cotransporter 2 (SGLT2) inhibitor empagliflozin, the dipeptidyl peptidase-4 (DPP-4) inhibitor linagliptin, and extended-release metformin, for oral treatment of type 2 diabetes in adults. Empagliflozin and linagliptin have been available in a fixed-dose combination as Glyxambi since 2015, and both have been available in 2-drug combinations with extended-release metformin for years (see Table 1).

In a randomized, placebo-controlled trial, the sodium-glucose cotransporter 2 (SGLT2) inhibitor empagliflozin (Jardiance – Boehringer Ingelheim/Lilly) reduced the composite risk of cardiovascular death or hospitalization for worsening heart failure (HF) in patients with heart failure with reduced ejection fraction (HFrEF), whether or not they had type 2 diabetes. To date, empagliflozin has not been approved by the FDA for such use. The SGLT2 inhibitor dapagliflozin (Farxiga) was approved by the FDA for this indication earlier this year.