Biologics License Application

9
Dec

FDA PMA and BLA for APLIGRAF and GINTUIT

Class III Medical Device and Biologics License Application (BLA) Class III Medical Device APLIGRAF: P950032 Expedited processing eras authorized on May 30 1995 based on the potential of Apligraf to provide a clinically important advance over existing alternatives in the treatment of chronic venous insufficiency ulcers. Intended Use/Indications Apligraf is indicated for use with standard therapeutic compression for the treatment of non infected partial and full

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18
Jul

"Recombinant Esterase Inhibitor" Approved for the Treatment of Acute Attacks of Hereditary Angioedema

By Admin The United States Food and Drug Administration (FDA) approves Esterase Inhibitor (Recombinant)-RUCONEST FDA is issuing Department of Health and Human Services U.S. License No. 1857 to Pharming Group NV, (Leiden, the Netherlands, “firm”), under the provisions of section 351(a) of the Public Health Service Act controlling the manufacture and sale of biological products. The license authorizes the firm to

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