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 Duopa (Abbvie), a carbidopa/levodopa enteral suspension, for treatment of motor fluctuations in patients with advanced Parkinson's disease (PD). It has been available in Europe since 2001.In patients with advanced PD, emptying of the stomach may be delayed and unpredictable, which can affect the rate and amount of absorption of carbidopa/levodopa and its efficacy. To bypass the stomach, the new formulation is delivered through a nasojejunal (NJ) tube or percutaneous endoscopic gastrostomy with jejunal (PEG-J) tube.A randomized, double-blind, active-controlled, 12-week...

The FDA has approved two new drugs for treatment of specific subtypes of acute myeloid leukemia (AML).Vyxeos (Jazz Pharmaceuticals) is a liposomal fixed-dose combination of daunorubicin and cytarabine, the standard drugs used for induction treatment of AML. It is approved for induction and consolidation treatment in adults with newly diagnosed chemotherapy- or radiation-related AML or AML with myelodysplasia-related changes. Patients with these subtypes of AML have a poor prognosis. The rationale for development of the combination was that nano-scale liposomal drug delivery vehicles prolong...

The FDA has required changes in the labeling of all systemic fluoroquinolone antibiotics to strengthen warnings about the risk of severe hypoglycemia and mental health effects associated with their use.1An FDA review identified 67 cases of hypoglycemic coma associated with fluoroquinolone use, 22 of which resulted in death or disability. Most cases occurred in patients with risk factors such as diabetes (especially those taking a sulfonylurea), older age, or renal insufficiency.1 In observational studies in older adults and patients with diabetes, fluoroquinolones have been associated with...

The FDA has required a new warning in the labels of prescription and over-the-counter products containing nonsteroidal anti-inflammatory drugs (NSAIDs) advising against their use during pregnancy beginning at 20 weeks’ gestation because of a risk of renal dysfunction in the fetus that could lead to low amniotic fluid levels (oligohydramnios) and neonatal renal impairment. NSAID labels previously warned against use of the drugs beginning at 30 weeks' gestation because of a risk for premature closure of the ductus arteriosus and persistent neonatal pulmonary hypertension

Radicava ORS, an oral suspension formulation of the free radical scavenger edaravone (Mitsubishi Tanabe Pharma), has been approved by the FDA for treatment of amyotrophic lateral sclerosis (ALS). An IV formulation of edaravone (Radicava) has been available since 2017.

In 1989, Photoplex (Allergan Herbert), a combination of the dibenzoyl methane avobenzone (Parsol 1789) and the aminobenzoic acid (PABA) ester padimate O, was the first 'broad spectrum' sunscreen to become available in the USA (Medical Letter, 31:59, 1989). Now, Shade UVAGuard (Schering-Plough), a similar product, has been approved by the US Food and Drug Administration; it also contains avobenzone, plus the benzophenone oxybenzone and octyl methoxycinnamate.

Glatiramer acetate (Copaxone - Teva Marion Partners), formerly known as copolymer-l, has been approved by the US Food and Drug Administration (FDA) for treatment of relapsing-remitting multiple sclerosis (MS). Interferon β-1b (Betaseron) and interferon β-1a (Avonex - Medical Letter, 38:63, 1996) were previously approved for this indication.

Extracts made from leaves of the ginkgo tree (Ginkgo biloba) are available in the uSA as deitary supplements, in France and Germany as licensed drugs and worldwide as herbal remedies for treatment of dementia and many other indications.

Once-a-week formulations of alendronate (Fosamax) in 35- and 70-mg tablets have now been approved by the FDA and are being heavily promoted for prevention and treatment of postmenopausal osteoporosis. A new formulation of risedronate (Actonel) for once-a-week use is under development and may be available next year.