Formulary staff

Genentech’s glofitamab is a bispecific antibody being reviewed to treat adults with large B-cell lymphoma. The FDA is expected to make a decision on approval by July 1, 2023.

I/Ontak is an engineered IL-2-diphtheria toxin fusion protein. The PDUFA target action date is Sept. 28, 2023.

The move follows an April 29 vote by the FDA Oncology Drugs Advisory Committee.

FDA has eased restrictions on patient access to the controversial diabetes drug rosiglitazone (Avandia, GlaxoSmithKline). The agency made its determination after an FDA Advisory Committee reviewed the drug in June 2013 and voted to lift its restrictions, and new information was released indicating that the drug carries no heightened cardiovascular risk.

FDA approved the first adjuvanted vaccine for the prevention of H5N1 influenza, commonly known as avian or bird flu. The vaccine, Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, is for use in people aged 18 years and older who are at increased risk of exposure to the H5N1 influenza virus.

FDA has requested label and packaging changes for certain over-the-counter (OTC) topical antiseptic products to decrease the risk of infections from these products, which in rare cases have resulted in deaths.

FDA has approved the first generic versions of Aciphex (rabeprazole sodium) delayed-release tablets, used to treat gastroesophageal reflux disease (GERD) in adults and adolescents (aged 12 years and up).

FDA approved antiepileptic drug eslicarbazepine acetate (Aptiom, Sunovion Pharmaceuticals) for use as adjunctive treatment of partial onset seizures, the most common type of seizure seen in people with epilepsy.

New data evaluating the investigational protease inhibitor faldaprevir in combination with pegylated interferon and ribavirin (PegIFN/RBV), studied in genotype 1 (GT1) patients with hepatitis C (HCV), were presented at the 64th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD), also known as The Liver Meeting, in Washington, DC.

FDA has approved a new boxed warning for the anti-seizure drug ezogabine (Potiga) because of the potential risk of vision loss, retinal abnormalities, as well as skin, nail, mucous membrane, and sclera discoloration. The agency recommends that ezogabine use be limited to individuals who have not responded to alternative therapies for seizure control, and when the benefits of treatment are greater than the risks.

FDA has approved obinutuzumab (Gazyva, Genentech, a member of the Roche Group), also known as GA101, in combination with chlorambucil chemotherapy for the treatment of patients with previously untreated chronic lymphocytic leukemia (CLL).