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Strensiq FDA Approval History

FDA Approved: Yes (First approved October 23, 2015)
Brand name: Strensiq
Generic name: asfotase alfa
Dosage form: Injection
Company: Alexion Pharmaceuticals, Inc.
Treatment for: Hypophosphatasia

Strensiq (asfotase alfa) is a tissue nonspecific alkaline phosphatase enzyme replacement therapy indicated for the treatment of patients with perinatal, infantile and juvenile-onset hypophosphatasia (HPP).

Development Timeline for Strensiq

DateArticle
Oct 23, 2015ApprovalFDA Approves Strensiq (asfotase alfa) for Perinatal, Infantile and Juvenile-Onset Hypophosphatasia
Dec 30, 2014Alexion Completes Rolling BLA Submission to FDA for Asfotase Alfa for Hypophosphatasia

Further information

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