ICLUSIG (ponatinib) tablets for oral use Initial U.S. Approval: 2012

• Trade Name: On Request
• Generic Name: ponatinib
• Dosage Forms & Strength:Tablets: 15 mg and 45 mg

Ponatinib was approved by the US FDA on December 14, 2012, for patients with resistant or intolerant CML and Ph+ ALL, based on results of the PACE phase II trial reported days earlier at the annual ASH meeting. Because the approval was under the FDA Accelerated Approval program the applicant was required to carry out additional studies. Based on these additional studies, the FDA granted in 2016 full approval and updated the label to include patients with chronic phase, accelerated phase, or blast phase chronic myeloid leukemia and Philadelphia chromosome-positive acute lymphoblastic leukemia for whom no other tyrosine kinase inhibitor therapy is indicated. Approval was also granted for T315I-positive and T315I-positive Philadelphia chromosome positive acute lymphoblastic leukemia.

Source Content From US FDA

ICLUSIG (ponatinib) tablets is a prescription medicine, it can be accessed through the Named Patient Program (NPP) for treatment in India - Gurgaon, Mumbai, Delhi, Kolkata, Chennai, Bangalore, Hyderabad, Ahmedabad, Pune, and Surat. To inquire about the cost price of purchasing ICLUSIG and arranging delivery to your location, please get in touch with Mr. Rakesh at +91 9910645395 or send an enquiry to info@cancermedicinesnetwork. We assure you of the quality of the product and guarantee delivery in accordance with your specific requirements.