First-time generic drug approvals, July 2008

FDA has set an action date of March 31, 2024, for marnetegragene autotemcel to treat infants with a serious and often fatal immunodeficiency.

Biogen is still evaluating launch timeline for Tofidence, and information on pricing will be available closer to launch.

At issue are findings from the agency’s inspection of a third-party manufacturing company. The FDA indicated there were no concerns about the safety or labeling of lebrikizumab.

The two-component therapy of Pombiliti plus Opfolda to treat adults living with late-onset Pompe disease will have an annual list price of $650,000.

Odronextamab is a bispecific antibody to treat relapsed/refractory follicular lymphoma and diffuse large B-cell lymphoma. The target action date is March 31, 2024.

Exxua is approved to treat adults with major depressive disorder, but its labeling does not contain warnings about sexual function or weight gain.