First-time generic drug approvals, November 2008

Alvotech’s Selarsdi (ustekinumab-aekn), a biosimilar referencing Stelara (ustekinumab), gained FDA approval, making it the second ustekinumab biosimilar and second for the company to be given the green light for the American market.

The vaccine combines the antigenic components of its two meningococcal vaccines: Bexsero and Menveo. The action date is Feb. 14, 2025.

Fasenra is now approved to treat patients aged 6 and older with eosinophilic asthma, a rare form of asthma.

The FDA is reviewing two novel therapies: a psychedelic-assisted therapy for PTSD with a target action date of Aug. 11, 2024, and therapy for schizophrenia that does not directly block dopamine receptors with an action date of Sept. 26, 2024.

The FDA is currently reviewing tarlatamab for small-cell lung cancer with a review date in June and datopotamab deruxtecan for non-small cell lung cancer with a review date in the fourth quarter.

FDA officials are looking for additional information about the infusion device used to deliver apomorphine.