FDA Approves Zonisade
Azurity Pharmaceuticals and its partner, Eton Pharmaceuticals, received approval from the U.S. Food and Drug Administration (FDA) on July 15, 2022, for Zonisade™ (zonisamide oral suspension). A new dosage form of an anticonvulsant that has been available as capsules in the U.S. for 20 years, it is approved in combination with other drugs to treat partial epileptic seizures for patients at least 16 years old.
Dosing begins at 100mg per day and increases by 100mg per day at two weeks intervals until the recommended dose of 400mg per day is reached. The total daily dose may be taken all at once or divided into two parts. Azurity, which will market Zonisade, has not yet announced a launch date or cost. It will be dispensed in 150mL bottles that contain 100mg/5mL.
FDA Approves Opzelura to Treat Vitiligo
Opzelura™ (ruxolitinib – Incyte) cream, 1.5%, originally FDA approved on Sept. 21, 2021, to treat atopic dermatitis, has been given a new indication. It was approved on July 18, 2022, as the first drug for treating patients who are 12 years old and older and who have nonsegmental vitiligo. Up to three million Americans have been diagnosed with vitiligo, an autoimmune condition caused by a deficiency of melanocytes, the cells that give skin its color. Individuals who have the condition have random areas of very light-colored skin. By interrupting transmission through the Janus-associated kinase (JAK) channel, Opzelura is believed to decrease inflammation involved in the disorder.
To treat vitiligo, the cream is applied in a thin layer to affected areas two times a day. No more than one-tenth of the total body surface should be covered at any time, but treatment can continue indefinitely. Patients should avoid getting Opzelura on their eyes, genitals and mucous membranes of the mouth and nose.
In clinical trials, one year of active treatment produced improvements in facial skin tone of 75% or greater for about one-half of patients and 90% or greater for around one-third of patients using Opzelura. It should not be used at the same time as an oral JAK inhibitor, such as Xeljanz® (tofacitinib); an immunosuppressant, such as cyclosporine; or a biologic therapy, such as Dupixent® (dupilumab).
Its labeling carries the same boxed warnings as oral JAK inhibitors that are used to treat inflammatory conditions do. They outline increased risks of blood clots, cancer and serious infections that may be associated with the use of a JAK inhibitor. Patients taking or using one of them also should be screened for tuberculosis (TB) before starting treatment and periodically while therapy continues.
Recall: Magnesium Citrate and Citroma
On July 15, 2022, Vi-Jon extended a recall of a single lemon-flavored magnesium citrate product to include all lots of over 30 store-branded magnesium citrate and Citroma products that are made in the same Vi-Jon facility. The recalled 10-ounce bottles may contain bacteria that could cause severe infections for immunocomprom