The U.S. Advisory Committee on Immunization Practices has recommended administration of the quadrivalent conjugated polysaccharide meningococcal vaccine (Menactra – Sanofi Pasteur) to all persons 11 to 18 years old, particularly those entering high school and college freshmen living in dormitories.1,2 The peak incidence of meningococcal disease, after early childhood, occurs in the 15-19 year-old age group. The conjugate vaccine is more immunogenic than the meningococcal capsular polysaccharide vaccine (Menommune – Sanofi Pasteur).ADVERSE EFFECTS — The most common adverse reactions with...

An extended-release oral formulation of guanfacine hydrochloride (Intuniv – Shire), a selective alpha_2A-adrenergic agonist, has been approved by the FDA for treatment of attention-deficit/hyperactivity disorder (ADHD) in children 6-17 years old.

The Medical Letter recently reviewed a topical gel formulation of testosterone (Fortesta) for treatment of hypogonadism in men. A topical testosterone replacement product for application to the axilla, Axiron (Lilly) solution, has now become available for the same indication. This site of application presumably minimizes the risk of transferring the drug to a family member or sexual partner.

The FDA has approved a sublingual powder formulation of nitroglycerin (GoNitro – Espero) for prevention or acute relief of an attack of angina pectoris. It is the first powder formulation of nitroglycerin to become available in the US. Most patients with angina use sublingual nitroglycerin tablets (Nitrostat, and generics). Translingual spray formulations of nitroglycerin (NitroMist, Nitrolingual Pumpspray, and generics) are also available.

Sotorasib (Lumakras — Amgen), an oral KRAS inhibitor, has received accelerated approval by the FDA for treatment of KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC) in adults who received at least one prior systemic therapy. Accelerated approval was based on the overall response rate and duration of response. KRAS mutations are found in 25-30% of non-squamous-cell NSCLC cases and the G12C mutation is the most common KRAS mutation. Sotorasib is the first KRAS inhibitor to be approved in the US.

The US Centers for Disease Control and Prevention (CDC) has reported that measles outbreaks have occurred in New York City, California and Arizona in 2008, and additional cases have been confirmed in Michigan, Wisconsin, Hawaii, New York State, Pennsylvania, Illinois and Virginia (CDC Health Advisory, May 1, 2008). To date, 63 of the 64 infected patients were unvaccinated, and 54 of the cases were associated with importation of the disease. Both measles infection and vaccination (2 doses at least 28 days apart, with the first dose no earlier than 12 months of age) generally provide lifelong...

The FDA has approved a buccal tablet formulation of miconazole (Oravig – Strativa) for local treatment of oropharyngeal candidiasis in adults. Miconazole has been available for many years in topical formulations for treatment of superficial fungal infections and vulvovaginal candidiasis.

The oral tyrosine kinase inhibitor neratinib (Nerlynx – Puma Biotechnology) has been approved by the FDA for use in combination with capecitabine (Xeloda, and generics) for treatment of advanced or metastatic human epidermal growth factor receptor 2 (HER2)-positive breast cancer in adults who received ≥2 prior anti-HER2-based regimens for metastatic disease. It was previously approved for use as monotherapy for extended adjuvant treatment of adults with early-stage, HER2-positive breast cancer following adjuvant trastuzumab (Herceptin)-based therapy. HER2 is overexpressed in...

The oral kinase inhibitor tucatinib (Tukysa – Seagen) has received accelerated approval from the FDA for use in combination with trastuzumab (Herceptin) for treatment of adults with RAS wild-type human epidermal growth factor receptor 2 (HER2)-positive unresectable or metastatic colorectal cancer that has progressed following treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy regimens. Tucatinib was approved in 2020 for use in combination with trastuzumab and capecitabine (Xeloda, and generics) for treatment of adults with advanced unresectable or...

Tadalafil (Cialis - Lilly Icos) is the third oral drug to be approved by the FDA for treatment of erectile dysfunction. It has a longer duration of action than sildenafil (Viagra) or vardenafil (Levitra - Medical Letter 2003; 45:77).