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...

Maribavir (Livtencity – Takeda), an oral cytomegalovirus (CMV) pUL97 kinase inhibitor, has been approved by the FDA for treatment of post-transplant CMV infection refractory to standard antiviral therapy in patients ≥12 years old who weigh at least 35 kg.

Mobocertinib (Exkivity – Takeda), an oral kinase inhibitor, has received accelerated approval from the FDA for treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations in adults whose disease has progressed on or after platinum-based chemotherapy. Accelerated approval was based on the overall response rate and duration of response. Mobocertinib is the second drug to become available in the US for this indication; the IV EGFR-MET bispecific antibody amivantamab (Rybrevant) was approved...

AD-Detect (Quest), a blood test to evaluate Alzheimer's disease risk, is being marketed directly to consumers. It has not been cleared or approved by the FDA (laboratory-developed tests like this one currently do not need FDA authorization to be marketed).

The FDA has approved a new indication for prevention of anal cancer and anal intraepithelial neoplasia in both sexes for the human papillomavirus (HPV) vaccine Gardasil (Merck). This vaccine is already FDA-approved for prevention of cervical cancer and genital warts in females 9-26 years old and for prevention of genital warts in males 9-26 years old. HPV types 6 and 11 cause about 90% of genital warts. Types 16 and 18 cause more than 70% of cervical cancer and about 80% of anal cancer.1 Gardasil is highly effective in preventing infection with HPV types 6, 11, 16 and 18 in both males and...

The FDA has asked Impax Laboratories/Teva Pharmaceuticals to stop production and distribution of Budeprion XL 300 mg, a generic extended-release formulation of the antidepressant bupropion (Wellbutrin XL), because it has found that Budeprion XL 300 mg releases bupropion more rapidly than Wellbutrin XL 300 mg, the original brand name product. Patients switched from the brand name to the generic formulation have complained for years that the generic was less effective and caused more side effects than the original formulation. In 2007, ConsumerLab.com, an independent laboratory, conducted...

The transdermal patch formulation of the anticholinergic drug oxybutynin (Oxytrol – Watson) is now available over the counter (OTC) as Oxytrol for Women (MSD) for use in women with overactive bladder (OAB). It is the first treatment for OAB to become available OTC. Oxybutynin remains available only by prescription for men.OAB, characterized by symptoms of urgency, frequency, and incontinence with no obvious cause, occurs mainly in older women.1 Behavioral modification, including fluid schedules, timed voiding, pelvic exercises, and urge suppression, is usually tried first.Anticholinergic...

The FDA has approved use of dinutuximab (Unituxin [yoo ni tux' in] – United Therapeutics) in combination with interleukin-2 (IL-2), granulocyte-macrophage colony-stimulating factor (GM-CSF), and isotretinoin for treatment of children with high-risk neuroblastoma who previously responded to first-line therapies. Dinutuximab is a monoclonal antibody that binds to GD2, a glycolipid that is overexpressed on the surface of neuroblastoma cells.1Dinutuximab received a priority review and orphan drug designation. Approval was based on the results of an open-label trial in 226 patients with high-risk...

The FDA has approved oral cholic acid (Cholbam – Retrophin) for treatment of children and adults with bile acid synthesis disorders caused by single enzyme defects and for adjunctive treatment of peroxisomal disorders such as Zellweger spectrum disorders in patients who have liver disease, steatorrhea, or complications from fat-soluble vitamin malabsorption. Patients with these rare inborn errors of bile acid metabolism cannot synthesize primary bile acids such as cholic acid, resulting in reduced bile flow, decreased absorption of fat and fat-soluble vitamins, and development of liver...

Intravenous formulations of immune globulin (IVIG) have been available for more than ten years for treatment of immune deficiency (Medical Letter, 24:81, 1982). Seven preparations are now licensed in the USA, with additional indications for their use.