Besremi Approved

PharmaEssentia received approval from the U.S. Food and Drug Administration (FDA) on Nov. 12, 2021, for Besremi® (ropeginterferon alfa-2b-njft). It is the first interferon product indicated for treating adults who have polycythemia vera, a rare type of blood cancer. Given by subcutaneous (SC) injections once every two weeks, the recommended starting dose is 100mcg, which can be increased in 50mcg increments up to a maximum of 500mcg/dose depending on the patient’s response to treatment. If blood components have stabilized after one year of therapy, treatments may be changed to once every four weeks. Prefilled, one-dose syringes should be kept in the refrigerator and also protected from exposure to light. An exact date has not been announced, but a launch is expected in the coming weeks. It has a boxed warning that using any interferon alpha product could trigger or exacerbate some autoimmune, neuropsychiatric and other conditions. Besremi will be distributed through a small network of specialty pharmacies

FDA Approves Eprontia

The first commercially available liquid formulation of topiramate, Eprontia™ oral solution, was approved by the U.S. Food and Drug Administration (FDA) on Nov. 5, 2021. By itself, Eprontia is indicated to treat partial-onset and primary generalized tonic-clonic seizures for patients 2 years of age and older and to prevent migraine headaches for patients 12 years of age and older. Along with other medications, it also is approved a as treatment for patients at least two years old who have partial-onset seizures, primary generalized tonic-clonic seizures or seizures associated with Lennox-Gastaut syndrome. Doses, which are taken twice daily, depend on the patient’s age, weight and stage of treatment. In the U.S., Azurity Pharmaceuticals plans to market Eprontia, which was developed by Eton Pharmaceuticals, before the end of 2021. Its pricing has not been announced.

Withdrawal

On Nov. 5, 2021, Teligent permanently withdrew all of its lidocaine 2.5%/prilocaine 2.5% topical cream, 30gm from the U.S. market. It may contain or develop unacceptable levels of unspecified impurities before the expiration dates. Both ingredients are topical anesthetics used to numb skin before injections or other procedures. Although the potential harm to patients is minimal, the product will not be returned to sale. For additional information, please call Teligent Customer Service at 856.697.1441, ext. 1062 on weekdays from 9