Exenatide injection (Byetta - Amylin/Lilly), a synthetic peptide that stimulates release of insulin from pancreatic beta cells, has been approved by the FDA as adjunctive therapy for patients with type 2 diabetes who have not achieved optimal glycemic control on metformin (Glucophage, and others), a sulfonylurea, such as glyburide (DiaBeta, and others), or both. Exenatide is not indicated for use with insulin.

Avandaryl, a new fixed-dose tablet combining the thiazolidinedione rosiglitazone (Avandia) and the sulfonylurea glimepiride (Amaryl, and others), was recently approved by the FDA for treatment of type 2 diabetes. It is approved for patients already taking a combination of rosiglitazone and a sulfonylurea or those not adequately controlled on rosiglitazone or sulfonylurea monotherapy. Rosiglitazone is also available in a fixed-dose combination with metformin (Avandamet). Most patients with type 2 diabetes eventually require 2 drugs with different mechanisms to control...

In the short time since fluoxetine (Prozac - Lilly) first became available in the USA (Medical Letter, 30:45, 1988), it has become the most frequently prescribed of all antidepressants. Some recent reports, however, have questioned its safety.

The FDA has received new reports of serious and life-threatening hypersensitivity reactions to omalizumab (Xolair – Genentech), a monoclonal anti-IgE antibody injected subcutaneously for treatment of asthma (Med Lett Drugs Ther 2003; 45:67), and has added a black-box warning to the package insert.Postmarketing reports submitted to the FDA included 124 reports of anaphylaxis among an estimated 57,300 patients (0.2%) who might have been treated with the drug between June 2003 and December 2006. Anaphylaxis occurred after the first dose of Xolair in 39% of cases, after a 2nd dose in 19%, after...

Bupropion (Wellbutrin - GlaxoSmithKline, and others) is a norepinephrine and dopamine reuptake inhibitor that has been a useful antidepressant because, unlike some other antidepressants, it does not cause sexual dysfunction, weight gain or sedation. Some patients who were switched from Wellbutrin to a generic alternative have reported worsening side effects and relapse of previously controlled depressive symptoms.1 Most of the complaints have come from patients switched from Wellbutrin XL 300 mg to the generic 300-mg formulation of extended-release bupropion marketed by Teva (Budeprion XL).2...

The FDA has approved dolutegravir (doll-you-TEG-rah-veer; Tivicay – Viiv Healthcare), an integrase strand transfer inhibitor (INSTI), for treatment of HIV-1 infection in adults and in children ≥12 years old who weigh at least 40 kg. It is the third INSTI to be approved by the FDA; raltegravir and elvitegravir were approved earlier.

The FDA has approved racemic amphetamine sulfate (Evekeo – Arbor) for oral treatment of attention-deficit/hyperactivity disorder (ADHD) in children ≥3 years old. It was also approved for treatment of narcolepsy in patients ≥6 years old and for short-term treatment of obesity in patients ≥12 years old.

The FDA has approved Synjardy (Boehringer Ingelheim/Lilly), a fixed-dose combination of the sodium-glucose co-transporter 2 (SGLT2) inhibitor empagliflozin (Jardiance) and metformin (Glucophage, and others), for treatment of patients with type 2 diabetes not adequately controlled on either of these drugs alone or already being treated with both empagliflozin and metformin. It is the third SGLT2 inhibitor/metformin combination to be approved in the US.

The FDA has approved Arymo ER (Egalet), a new extended-release, abuse-deterrent tablet formulation of morphine sulfate, for management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Arymo ER can only be marketed to deter abuse by injection because another single-entity, extended-release morphine product, MorphaBond, which has not been marketed to date, has marketing exclusivity for deterrence of abuse by the intranasal route through October 2018.

View the Table: Treatments Considered for COVID-19