The FDA has approved an effervescent tablet formulation of acetylcysteine (Cetylev – Arbor) to prevent or lessen hepatic injury after acetaminophen overdose. Acetylcysteine has been available for years in an IV solution (Acetadote, and generics) and an oral solution for the same indication; use of the oral solution has been limited by its unpleasant odor and taste.

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 investigational neutralizing IgG1 monoclonal antibody bamlanivimab (LY-CoV555; Lilly) has been granted an FDA Emergency Use Authorization (EUA) for treatment of recently diagnosed mild to moderate COVID-19 in patients who are ≥12 years old, weigh at least 40 kg, and are at high risk for progressing to severe disease and/or hospitalization (see Table 1).

Odevixibat (Bylvay – Albireo), an oral ileal bile acid transporter (IBAT) inhibitor, has been approved by the FDA for treatment of pruritus in patients ≥3 months old with progressive familial intrahepatic cholestasis (PFIC). It is the first drug to be approved in the US for this indication.

The FDA has approved a generic injectable formulation of the opioid antagonist nalmefene (Purdue) for the management of known or suspected opioid overdose. Revex, the reference product, was withdrawn from the market in 2008 for commercial reasons.

An oral nonopioid analgesic is often sufficient for acute treatment of mild to moderate migraine pain without severe nausea or vomiting. A triptan is the drug of choice for treatment of moderate to severe migraine in most patients without vascular disease. Treatment of pain when it is still mild to moderate in intensity improves headache response and reduces the risk of recurrence.

Atrial fibrillation (AF) is the most common arrhythmia in the world. Risk factor modification, anticoagulation, rhythm control, and rate control are the four pillars of its management. American College of Cardiology/American Heart Association (ACC/AHA) guidelines on management of AF were updated recently.

Tacrolimus ointment (Protopic) has been approved by the FDA in 0.03% and 0.1% formulations for treatment of atopic dermatitis. Tacrolimus is used systemically (Prograf) to prevent rejection of organ transplants.

The FDA recently announced that it was investigating 38 reports of loss of vision in men who took sildenafil (Viagra), which has been used to treat erectile dysfunction since 1998.

The FDA has approved the oral direct thrombin inhibitor dabigatran (da big’ a tran) etexilate (Pradaxa – Boehringer Ingelheim) for prevention of thromboembolic stroke in patients with non-valvular atrial fibrillation. It has been available in Canada (Pradax) since 2008 for prevention of thromboembolism in patients undergoing knee or hip replacement surgery and was recently approved there for use in atrial fibrillation.