Active substance
Lapatinib ditosylate
- US FDA 3
- Safety 1
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| TYKERB | EQ 250MG BASE | tablet · oral | NOVARTIS | Prescription | 13 Mar 2007 |
| LAPATINIB DITOSYLATE | EQ 250MG BASE | tablet · oral | NATCO PHARMA LTD | Prescription | 29 Sep 2020 |
| LAPATINIB DITOSYLATE | EQ 250MG BASE | tablet · oral | TEVA PHARMS USA INC | Prescription | 16 Aug 2024 |
Safety signals and safety-related labeling changes
- US FDA 27 Mar 2022 TYKERB — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.