Approvals· September 4, 2026 · 36 min read
Lirafugratinib's Sept 27 PDUFA Does Not Rewrite Pemazyre PAs or Lytgobi CDx
By Ran Chen#PDUFA Date#FDA Approval#NDA Approval
Topic
Orange Book
Patent/exclusivity records, therapeutic-equivalence codes, reference-listed drugs, and ANDA planning.
Approvals· September 3, 2026 · 34 min read
Injectafer's Phosphate Boxed Warning Does Not Rewrite J1439, AP Generics, or Oral-Iron PAs
By Ran Chen#Boxed Warning#Label Warnings#FDA Approval
Approvals· September 2, 2026 · 33 min read
Aqneursa's Sept 19 A-T PDUFA Does Not Rewrite NPC-Only PAs or the 15 kg Floor
By Ran Chen#PDUFA Date#FDA Approval#NDA Approval
Specialty· August 31, 2026 · 36 min read
Generic Erleada (Apalutamide): U.S. Entry, Patents, and Launch Signals
By Ran Chen#Oncology#Generic Entry#Orange Book
Generics· August 27, 2026 · 17 min read
FDA's Cabazitaxel 314.161 Notice: ANDAs to Dead 10 mg/mL NDA, Not Jevtana Kit
By Ran Chen#Generics#Orange Book#505(b)(2)
Approvals· August 27, 2026 · 18 min read
Tivicay PD's Neonatal Expansion: Term, 2 kg Floor; Tablets Do Not Substitute
By Ran Chen#FDA Approval#HIV#Infectious Disease
Generics· August 25, 2026 · 18 min read
Dasynoc's CRL Is a Facility Letter: Nine AB Generics and Phyrago Occupy Access
By Ran Chen#Generics#505(b)(2)#Orange Book
Approvals· August 23, 2026 · 18 min read
Besremi's August 30 ET PDUFA: Second-Line vs Anagrelide, Not Hydroxyurea
By Ran Chen#PDUFA Date#FDA Approval#Orange Book
Generics· August 23, 2026 · 17 min read
FDA's August 2026 TE Final: 505(b)(2) Requests and Orange Book Blanks
By Ran Chen#Orange Book#505(b)(2)#FDA Approval
Generics· August 22, 2026 · 17 min read
FDA's August 2026 PSG Batch: Development Clock vs Orange Book Exclusivity
By Ran Chen#Generics#Orange Book#FDA