Lanreotide Injection (lanreotide) / Cipla - LARVOL DELTA

Cipla's $120-150M Lanreotide Product Faces Extended U.S. Recall, Resupply Unlikely (Scanx) - "The situation has worsened with the assessment that resupply is unlikely in H1 FY27, suggesting complex quality issues that require extensive remediation efforts...The recall carries substantial financial implications for Cipla's U.S. operations."

Commercial • Acromegaly • Gastrointestinal Neuroendocrine Tumor • Neuroendocrine Tumor • Pancreatic Neuroendocrine Tumor

Cipla gets USFDA nod for its generic formulation to treat pancreatic cancer (Financialexpress) - "Cipla Limited on Wednesday announced that it has received the final approval for its Abbreviated New Drug Application (ANDA) for Lanreotide Injection 120 mg/0.5 mL, 90 mg/0.3 mL, 60 mg/0.2 mL from the United States Food and Drug Administration (USFDA)....Lanreotide Injection is supplied as 120 mg/0.5 mL, 90 mg/0.3 mL, 60 mg/0.2 mL single-dose, pre-filled, ready-to-inject syringe....Cipla’s Lanreotide injection is indicated for the treatment of patients with Acromegaly and Gastroenteropancreatic Neuroendocrine Tumors (GEP-NETs). According to IQVIA (IMS Health), Somatuline Depot (Lanreotide) had US sales of approximately $898M for the 12 months ending March 2024."

FDA approval • Sales • Gastrointestinal Cancer • Neuroendocrine Tumor • Oncology • Pancreatic Cancer • Solid Tumor