Drugs such as Taxol, Cytarabine, Daunorubicin, Doxil, and Leucovorin are in short supply, delaying patients with various forms of cancer from getting the treatments they need or forcing them to seek alternative, possibly less-effective treatments, FDA announced recently.
FDA has issued a Safety Announcement warning that serious allergic reactions have been reported with the use of the antipsychotic medication asenapine maleate (Saphris).
FDA has approved orphenadrine citrate injection, USP (Sagent Pharmaceuticals), a skeletal muscle relaxant as an adjunct to rest, physical therapy, and other measures to support relief from acute, painful musculoskeletal conditions.
FDA has approved crizotinib (Xalkori, Pfizer), the first and only therapy specifically for patients with locally advanced or metastatic non-small-cell lung cancer that is ALK-positive as detected by an FDA-approved test.
FDA has approved tapentadol extended-release tablets (Nucynta ER, Janssen Pharmaceuticals), an oral analgesic taken twice daily, for the management of moderate-to-severe chronic pain in adults when a continuous, around-the-clock opioid analgesic is needed for an extended period of time.
FDA has approved onabotulinumtoxinA (Botox, Allergan) for injection for the treatment of urinary incontinence resulting from detrusor overactivity associated with a neurologic condition (e.g., spinal cord injury [SCI], multiple sclerosis [MS]) in adults who have an inadequate response to or are intolerant of an anticholinergic medication.
FDA has approved icatibant (Firazyr, Shire Human Genetic Therapies) injection for the treatment of acute attacks of hereditary angioedema (HAE) in patients 18 years of age and older.
FDA has notified healthcare professionals and patients that the antidepressant citalopram hydrobromide (Celexa, Forest Laboratories) should no longer be used at doses greater than 40 mg per day because it can cause abnormal changes in the electrical activity of the heart.
FDA has approved brentuximab vedotin (Adcetris, Seattle Genetics) to treat 2 types of lymphoma.
Apricus Biosciences and its wholly owned subsidiary, NexMed USA, have received FDA approval for over-the-counter sales of antifungal drug Tolnaftate-D, containing the company's NexACT technology, which transiently loosens the tight junction between the cells of the sealed skin to allow more permeation.