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Strensiq

asfotase alfa

351(a) Standalone BLA

Overview

Source: Purple Book

Proprietary name

Strensiq

Proper name

asfotase alfa

Licence type

351(a)

BLA number

125513

Applicant

Alexion Pharmaceuticals, Inc.

Center

CDER

Presentations

4

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
18MG/0.45ML	Injection	Subcutaneous	Single-Dose Vial	Rx	October 23, 2015
28MG/0.7ML	Injection	Subcutaneous	Single-Dose Vial	Rx	October 23, 2015
40MG/ML	Injection	Subcutaneous	Single-Dose Vial	Rx	October 23, 2015
80MG/0.8ML	Injection	Subcutaneous	Single-Dose Vial	Rx	October 23, 2015

Exclusivity

Source: Purple Book

Kind	Expires
Orphan exclusivity	October 23, 2022

Sources for this page

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