Details for New Drug Application (NDA): 215500
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NDA 215500 describes IWILFIN, which is a drug marketed by Uswm and is included in one NDA. It is available from one supplier. Additional details are available on the IWILFIN profile page.
The generic ingredient in IWILFIN is eflornithine hydrochloride. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the eflornithine hydrochloride profile page.
The generic ingredient in IWILFIN is eflornithine hydrochloride. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the eflornithine hydrochloride profile page.
Summary for 215500
| Tradename: | IWILFIN |
| Applicant: | Uswm |
| Ingredient: | eflornithine hydrochloride |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 215500
Generic Entry Date for 215500*:
Constraining patent/regulatory exclusivity:
TO REDUCE THE RISK OF RELAPSE IN ADULT AND PEDIATRIC PATIENTS WITH HIGH-RISK NEUROBLASTOMA (HRNB) WHO HAVE DEMONSTRATED AT LEAST A PARTIAL RESPONSE TO PRIOR MULTIAGENT, MULTIMODALITY THERAPY INCLUDING ANTI-GD2 IMMUNOTHERAPY Dosage:
TABLET;ORAL |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Pharmacology for NDA: 215500
| Mechanism of Action | Decarboxylase Inhibitors |
Medical Subject Heading (MeSH) Categories for 215500
Suppliers and Packaging for NDA: 215500
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| IWILFIN | eflornithine hydrochloride | TABLET;ORAL | 215500 | NDA | USWM, LLC | 78670-150 | 78670-150-01 | 1 BOTTLE in 1 CARTON (78670-150-01) / 100 TABLET in 1 BOTTLE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 192MG BASE | ||||
| Approval Date: | Dec 13, 2023 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Dec 13, 2030 | ||||||||
| Regulatory Exclusivity Use: | TO REDUCE THE RISK OF RELAPSE IN ADULT AND PEDIATRIC PATIENTS WITH HIGH-RISK NEUROBLASTOMA (HRNB) WHO HAVE DEMONSTRATED AT LEAST A PARTIAL RESPONSE TO PRIOR MULTIAGENT, MULTIMODALITY THERAPY INCLUDING ANTI-GD2 IMMUNOTHERAPY | ||||||||
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