ADMA Biologics Receives FDA Approval for License Transfers for BIVIGAM® and Nabi-HB®

- July 8th, 2019

ADMA Biologics NASDAQ:ADMA) has announced that the US Food and Drug Administration (FDA) has revoked the licenses for BIVIGAM and Nabi-HB from Biotest Pharmaceuticals US License No. 1792 and transferred and issued to ADMA’s US License No. 2019. As quoted in the press release: “We are very pleased to announce the U.S. License transfer of … Continued

ADMA Biologics NASDAQ:ADMA) has announced that the US Food and Drug Administration (FDA) has revoked the licenses for BIVIGAM and Nabi-HB from Biotest Pharmaceuticals US License No. 1792 and transferred and issued to ADMA’s US License No. 2019.

As quoted in the press release:

“We are very pleased to announce the U.S. License transfer of BIVIGAM® and Nabi-HB® from BPC to ADMA, as this was the final remaining regulatory item from the acquisition of the Biotest Therapy Business Unit transaction,” stated President and Chief Executive Officer, Adam Grossman.  “It is important for patients, prescribers and investors to recognize that FDA regulatory licensing is complex, particularly with respect to ADMA’s acquisition of the BTBU assets.  Since ADMA’s ownership and operation of the BTBU, we have received an acceptable FDA inspection classification, FDA approvals for two product submissions and now licenses issued in ADMA’s name for two FDA approved biologic drugs.  FDA’s license transfer of BIVIGAM® and Nabi-HB® to ADMA’s U.S. License 2019 constitutes a determination by FDA that the establishment and the products meet applicable requirements to ensure the continued safety, purity, and potency of the products.  Those applicable requirements also include FDA’s current Good Manufacturing Practice (“cGMP”).  Going forward, ADMA will manufacture and introduce both BIVIGAM® and Nabi-HB® into interstate commerce under ADMA’s U.S. License No. 2019 along with its recently approved patented Immune Globulin, ASCENIV®.”

Click here to read the full press release.

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