Development of abuse-deterrent opioid products, including reformulation of existing products, has become a priority for drug manufacturers and public health advocates. Since our last article on this subject, several new abuse-deterrent opioid formulations have been approved by the FDA, including an oxycodone tablet formulation (Roxybond – Inspirion) that is the first immediate-release opioid product FDA-approved to include claims of abuse deterrence in its labeling. No opioid formulation prevents consumption of a large number of intact dosage units, the most common method of...

The FDA has approved hydrogen peroxide 40% topical solution (Eskata – Aclaris Therapeutics) for treatment of raised seborrheic keratoses (SKs) in adults. It is the first drug to be approved for this indication. (Hydrogen peroxide is available over the counter for topical use as a 3% solution.)

The FDA has approved Crexont (Amneal), an extended-release capsule formulation of carbidopa/levodopa, for treatment of Parkinson's disease (PD), postencephalitic parkinsonism, and parkinsonism associated with carbon monoxide or manganese intoxication. Crexont contains a combination of immediate-release carbidopa/levodopa granules and extended-release levodopa pellets. An extended-release carbidopa/levodopa oral capsule (Rytary) has been available from the same manufacturer for years; the patent for Rytary expires in 2025.

Most respiratory tract infections are caused by viruses. Bacterial respiratory tract infections are usually treated empirically with antibiotic therapy that targets the most probable causative pathogens. Recommended antibiotic regimens for outpatient treatment of some common respiratory tract infections are listed in Table 1 for adults and Table 2 for children.

Mirtazapine (mir taz a peen; Remeron - Organon) has been approved by the US Food and Drug Administration for treatment of depression. A tetracyclic piperazinoazepine, it is an analog of mianserin, an antidepressant available in Europe, but is structurally unrelated to antidepressants previously available in the USA.

The FDA has approved an intravenous (IV) formulation of acetaminophen (Ofirmev – Cadence) for use in patients ≥2 years old for management of pain either as monotherapy (mild to moderate pain) or with an opioid (moderate to severe pain) and for reduction of fever.

The FDA has approved Cinvanti (Heron), an IV emulsion formulation of the substance P/neurokinin-1 (NK1) receptor antagonist aprepitant, for prevention of acute and delayed chemotherapy-induced nausea and vomiting (CINV) in adults. Aprepitant is also available in oral capsule and suspension formulations (Emend, and generics), and fosaprepitant, a prodrug of aprepitant, is available in an IV formulation (Emend for injection).

Zaleplon, a pyrazolopyrimidine hypnotic, was recently approved by the FDA for short-term treatment of insomia. Zaleplon, like zolpidem, is a non-benzodiazepine that binds to benzodiazepine receptors.

Botulinum toxin type A (Botox Cosmetic - Allergan) has received formal approval from the FDA for treatment of glabellar ("frown") lines in adults not more than 65 years old, and is being heavily advertised. Even before this approval, cosmetic use of botulinum toxin to reduce wrinkles on the face and neck had become a popular alternative to cosmetic surgery (Medical Letter 1999; 41:63). Botulinum toxin type A (Botox) and type B (Myobloc) are approved for treatment of cervical dystonia (Medical Letter 2001; 43:53), and type A has been approved since 1989 for treatment of strabismus and...