Iplex Purple Book BLA 021884
- BLA number
- 021884
- Proprietary names
- Iplex
- Proper names
- mecasermin rinfabate
- Applicant
- Insmed Incorporated
- Center
- CDER
- First observed release
- 2020-05-01
- Latest observed release
- 2026-06-01
- Newest archive release
- 2026-06-01
- FDA patent list
- No patents listed in the captured FDA patent list; source updated 2025-06-11
- Coverage
- Present in newest release
Latest Known Product Presentations#
Product, Proprietary name, Proper name table| Product | Proprietary name | Proper name | License type | Strength | Dosage form | Route | Presentation | Marketing | Licensure | Approval | Patent list provided |
|---|
| 001 | Iplex | mecasermin rinfabate | 351(a) | 36MG/0.6ML (60MG/ML) | Injection | Subcutaneous | Single-Dose Vial | Disc | Voluntarily Revoked | 2005-12-12 | |
Published Patent List#
No patents for this BLA were listed in the FDA Purple Book patent list captured from the source updated 2025-06-11.
Official Monthly Change Events#
Release, Event, Product table| Release | Event | Product | Name | License type | Status | Applicant |
|---|
| 2024-07-01 | U | 001 | Iplex | 351(a) | Disc | Insmed Incorporated |
| 2023-06-01 | U | 001 | Iplex | 351(a) | Disc | Insmed Incorporated |
| 2020-08-01 | U | 001 | Iplex | 351(a) | Disc | Insmed Incorporated |
| 2020-05-01 | R | 001 | Iplex | 351(a) | Disc | Insmed Incorporated |
Observed Product State History#
Release, Product, Name table| Release | Product | Name | License type | Marketing | Licensure | Approval |
|---|
| 2024-07-01 | 001 | Iplex | 351(a) | Disc | Voluntarily Revoked | 2005-12-12 |
| 2020-05-01 | 001 | Iplex | 351(a) | Disc | Licensed | 2005-12-12 |