FDA demands further studies in rejecting Adamis' epinephrine injection

7 June 2016

US-based Adamis Pharmaceuticals (Nasdaq: ADMS) has suffered a share-busting setback in its New Drug Application (NDA) for its epinephrine injection pre-filled single dose syringe (PFS) product for emergency treatment of acute anaphylaxis, a severe allergic reaction.

The US Food and Drug Administration (FDA) has asked the US-based specialty biopharmaceutical company for more data in a Complete Response Letter received on Friday, deeming the current body of evidence insufficient.

Changes were made to the PFS in response to the FDA’s original CRL received last March, and because of the alterations, the agency has indicated that in order to support approval of the product, Adamis must expand its human factors and reliability studies.

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