OpenRx Open Medications Explorer
© 2026 OpenRx · public-domain U.S. government data
On this page

Somavert

pegvisomant

351(a) Standalone BLA

Overview

Source: Purple Book
Proprietary name
Somavert
Proper name
pegvisomant
Licence type
351(a)
BLA number
021106
Applicant
Pharmacia & Upjohn Company LLC
Center
CDER
Presentations
5
First licensure
—

Presentations

Source: Purple Book
Every strength and presentation recorded in the Purple Book for this product.
Strength Dosage form Route Presentation Status Licensed
10MG For Injection Subcutaneous Single-Dose Vial Rx March 25, 2003
15MG For Injection Subcutaneous Single-Dose Vial Rx March 25, 2003
20MG For Injection Subcutaneous Single-Dose Vial Rx March 25, 2003
25MG For Injection Subcutaneous Single-Dose Vial Rx July 31, 2014
30MG For Injection Subcutaneous Single-Dose Vial Rx July 31, 2014

Exclusivity

Source: Purple Book
Kind Expires
Orphan exclusivityMarch 25, 2010

Sources for this page

Purple Book FDA Licence type, presentations, reference product, exclusivity