Table V.
Comparative overview of application types per country (for case studies simultaneously in the United States and Europe)
| Application type | ||||||
|---|---|---|---|---|---|---|
| Case study repositionings | Original indication | New indication | United States (N=23) | France (N=18) | United Kingdom (N=18) | Germany (N=17) |
| Duloxetine | Major depression disorder (MDD) | Generalized anxiety disorder (GAD) | sNDA (new indication) | Centralized | Centralized | Centralized |
| Imatinib | Chronic myeloid leukemia (CML) | Gastrointestinal stromal tumor (GIST) | sNDA (new indication) | Centralized | Centralized | Centralized |
| Imatinib | CML, GIST | Myelodysplastic/myeloproliferative diseases, metastatic dermatofibro-sarcoma protuberans (MDS/MPD, DFSP) | sNDA (new indication) | Centralized | Centralized | Centralized |
| Propranolol | Angina, hypertension | Migraine | sNDA (new indication) | National | National | –* |
| Methotrexate | Cancer | Rheumatoid arthritis (RA) | sNDA (new indication) | National | – | National |
| Rituximab | Non-Hodgkin's lymphoma (NHL) | RA | sBLA | Centralized | Centralized | Centralized |
| Botulinum Toxin A | Blepharospasm, cervical dystonia | Axillary hyperhidrosis | sBLA | National | National | National |
| Bosentan Monohydrate | Treatment of congestive heart failure (intended) | PAH | NDA type 1 section 505(b) | Centralized | Centralized | Centralized |
| Crizotinib | Anaplastic large-cell lymphoma (intended) | Non-small cell lung cancer (NSCLC) | NDA type 1 section 505(b) | Centralized | Centralized | Centralized |
| Galantamine | Post-polio paralysis and neuropathic pain (intended) | Alzheimer's disease | NDA type 1 section 505(b) | Mutual recognition | National | National |
| Plerixafor | Human immunodeficiency virus (HIV) (intended) | Mobilization of hematopoietic stem cell | NDA type 1 section 505(b) | Centralized | Centralized | Centralized |
| Sildenafil Citrate | Angina (intended) | ED ‘Viagra’ | NDA type 1 section 505(b) | Centralized | Centralized | Centralized |
| Minoxidil | Hypertension, oral formulation | MPB, topical formulation | NDA type 3 section 505(b) | National | National | National |
| Retinoic acid/Tretinoin | Acne (topical gel) | Acute promyelocytic leukemia (APL) (capsules) | NDA type 3 section 505(b) | Mutual recognition | National | – |
| Sildenafil Citrate | Angina (intended), erectile dysfunction (ED) ‘Viagra’ | Pulmonary arterial hypertension (PAH) ‘Revatio’ | NDA type 5 section 505(b) | Centralized | Centralized | Centralized |
| Finasteride | Benign prostatic hyperplasia (BPH) | Male pattern baldness (MPB) | NDA type 3 section 505(b) | Mutual recognition | National | – |
*
Not approved.