FDA approves labeling supplement for Janssen's Erleada (apalutamide)
Janssen Biotech received FDA approval this week for a labeling submission tied to Erleada, with a standard review priority.
Janssen Biotech's Erleada saw one regulatory update this week.
- The FDA approved a labeling submission (submission number 24) for Erleada, an oral apalutamide tablet available in 60MG and 240MG strengths, under Janssen Biotech's application NDA210951.1 The submission carried a standard review priority and the approval letter is dated July 2, 2026, with the updated label dated July 6, 2026.
Written by readthrough’s AI from the linked primary sources and fact-checked against them automatically before publishing. Not investment advice.