The FDA has approved a 0.016% gel formulation of the nitrogen mustard mechlorethamine (Valchlor – Actelion) for second-line topical treatment of patients with stage IA or IB mycosis fungoides, the most common type of cutaneous T-cell lymphoma. Topical nitrogen mustard has been used off-label for decades for this indication, usually as a pharmacy-compounded ointment, but no clinical trials evaluating its efficacy and safety have been done. Mechlorethamine is also available in an injectable formulation (Mustargen – Recordati) for the same and other indications.FDA approval of Valchlor was...

The FDA has approved belinostat (Beleodaq – Spectrum), an IV histone deacetylase (HDAC) inhibitor, for treatment of adults with relapsed or refractory peripheral T-cell lymphoma (PTCL). It is the third IV drug approved by the FDA for PTCL. The first was the antifolate drug pralatrexate (Folotyn), which was followed by the HDAC inhibitor romidepsin (Istodax). Vorinostat (Zolinza), an oral HDAC inhibitor, is FDA-approved for treatment of cutaneous T-cell lymphoma.

The FDA has approved pomalidomide (Pomalyst – Celgene), an oral thalidomide analog, for treatment of patients with multiple myeloma who have received at least 2 prior therapies including lenalidomide (Revlimid) and bortezomib (Velcade) and whose disease had progressed on or within 60 days of completion of the last therapy.

The FDA has approved a 1% cream formulation of the antiparasitic drug ivermectin (Soolantra – Galderma) for topical treatment of inflammatory lesions of rosacea. Ivermectin is available in the US in tablets (Stromectol, and generics) for treatment of onchocerciasis and other worm infestations and as a 0.5% lotion (Sklice) for treatment of head lice.

The FDA recently announced changes in the labeling of the hepatitis C drugs Sovaldi (sofosbuvir) and Harvoni (sofosbuvir/ledipasvir) to warn about a risk of serious and potentially fatal bradycardia when either drug is taken with the antiarrhythmic drug amiodarone (Cordarone, and others).1 Symptomatic bradycardia was reported following initiation of treatment with Harvoni or with Sovaldi plus simeprevir (Olysio) or the investigational antiviral drug daclatasvir in 9 patients already taking amiodarone; it occurred within 24 hours of starting hepatitis C therapy in 6 patients and within 2-12...

The FDA has now approved a recombinant, 9-valent, human papillomavirus (HPV) vaccine (Gardasil 9 – Merck) for use in girls and women 9-26 years old and boys 9-15 years old. The new vaccine is indicated to prevent diseases associated with infection with HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58, which include genital warts and cervical, vulvar, vaginal, and anal precancerous lesions and cancer. Two recombinant HPV vaccines are already available in the US: Gardasil prevents disease associated with HPV types 6, 11, 16, and 18, and Cervarix prevents disease associated with HPV...

The nasal spray formulation of the corticosteroid fluticasone propionate is now available over the counter (OTC) as Flonase Allergy Relief (GSK) in the same strength as the prescription product (Flonase, and generics) for patients ≥4 years old with seasonal or perennial allergic rhinitis. It is the second corticosteroid nasal spray to become available OTC; triamcinolone acetonide (Nasacort Allergy 24HR) was the first. Unlike prescription Flonase, the OTC product is FDA-approved for reduction of ocular as well as nasal symptoms. Brand-name prescription Flonase has been...

The FDA has approved edoxaban (Savaysa – Daiichi Sankyo), a once-daily, oral, direct factor Xa inhibitor, for treatment of venous thromoboembolism (VTE) and for prevention of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. It is the fourth new oral anticoagulant to be approved for VTE and nonvalvular atrial fibrillation.

Secukinumab (Cosentyx – Novartis), an injectable human interleukin (IL)-17A antagonist, has been approved by the FDA for treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy. It is the first IL-17 inhibitor to be approved for any indication in the US.

Tiotropium bromide, an inhaled long-acting anticholinergic available since 2004 as a dry powder inhaler (Spiriva Handihaler) for once-daily treatment of chronic obstructive pulmonary disease (COPD), has now also been approved in an inhalation spray formulation (Spiriva Respimat – Boehringer Ingelheim). According to the manufacturer, the Respimat device improves delivery of tiotropium to the lungs because, unlike with the Handihaler, it is not dependent on the strength of the patient’s breath intake.