First-time generic drug approvals, May 2009

Galderma officials said they have already identified changes to its manufacturing process for relabotulinumtoxinA, which is being reviewed as a treatment for frown lines and crows feet.

In a confirmatory trial, Exkivity did not meet the primary endpoint in treating patients with non-small cell lung cancer with EGFR exon 20 mutations. It will remain available while Takeda works with the FDA on withdrawal timing.

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.