Table 1.
Summary of liposomal products approved by FDA and EMA.
| Product Name | API | Approved Year/Area | Dosage Form | Adm. Route | Indication |
|---|---|---|---|---|---|
| Doxil Caelyx |
Doxorubicin hydrochloride (DOX·HCl) | 1995, US 1996, EU |
Suspension | IV | Ovarian cancer, Kaposi’s sarcoma, myeloid melanoma |
| DaunoXome | Daunorubicin | 1996, US | Suspension | IV | Kaposi’s sarcoma |
| AmBisome | Amphotericin B (AmpB) | 1997, US | Lyo | IV | Systemic fungal infection |
| DepoCyt DepoCyte |
Cytarabine | 1999, US 2001, EU |
Suspension | IT | Lymphomatous meningitis |
| Myocet | DOX·HCl | 2000, EU | 3 vials | IV | Breast cancer |
| Visudyne | Verteporfin | 2000, US 2000, EU |
Lyo | IV | Wet AMD |
| DepoDur | Morphine | 2004, US | Suspension | Epidural | Postoperative pain |
| Mepact | MTP-PE | 2009, EU | Lyo | IV | Osteosarcoma |
| Exparel | Bupivacaine | 2011, US 2020, EU |
Suspension | Local infiltration | Post-surgical analgesia |
| Marqibo | Vincristine Sulfate | 2012, US | 3 vials | IV | Leukemia |
| Onivyde | Irinotecan hydrochloride trihydrate | 2015, US 2016, EU |
Suspension | IV | Pancreatic adenocarcinoma |
| Vyxeos | Daunorubicin, cytarabine | 2017, US 2018, EU |
Lyo | IV | Leukemia |
| Shingrix | Recombinant varicella-zoster virus glycoprotein E | 2018, EU | 2 vials (powder and suspension) | IM | Against shingles and post-herpetic neuralgia |
| Arikayce | Amikacin sulfate | 2018, US 2020, EU |
Suspension | Oral inhalation | Lung disease |
This list is only for liposomal forms approved by FDA and EMA, excludes generics (e.g., doxorubicin hydrochloride (liposomal), lipid complexes (e.g., Abelcet, Amphotec, and Onpattro), and also excludes the nationally authorized liposomal products in Europe. Abbreviations: intravenous infusion (IV), intramuscular injection (IM), intrathecal injection (IT), lyophylization (Lyo), muramyl tripeptide phosphatidyl ethanolamine (MTP-PE).