New Drug Approvals Archive - May 2016

May 2016

Ameluz (aminolevulinic acid) Gel - formerly BF-200 ALA

Date of Approval: May 10, 2016
Company: Biofrontera AG
Treatment for: Actinic Keratosis

Ameluz (aminolevulinic acid) is a porphyrin precursor used in combination with the BF-RhodoLED lamp for photodynamic therapy (PDT) treatment of actinic keratoses on the face and scalp.

Biofrontera Announces U.S. FDA Approval of Ameluz and Activating BF-RhodoLED Device for Treatment of Actinic Keratosis
Ameluz (aminolevulinic acid) FDA Approval History

Tecentriq (atezolizumab) Injection

Date of Approval: May 18, 2016
Company: Genentech, Inc.
Treatment for: Bladder Cancer, Non-Small Cell Lung Cancer, Breast Cancer, Small Cell Lung Cancer

Tecentriq (atezolizumab) is a programmed death-ligand 1 (PD-L1) blocking antibody indicated for the treatment of advanced urothelial carcinoma; the treatment of metastatic non-small cell lung cancer (NSCLC); extensive-stage small cell lung cancer; and for use in combination with Abraxane for the treatment of metastatic triple-negative breast cancer.

Afstyla (antihemophilic factor (recombinant), single chain) for Injection

Date of Approval: May 25, 2016
Company: CSL Behring
Treatment for: Hemophilia A

Afstyla (antihemophilic factor (recombinant), single chain, is a recombinant, antihemophilic factor indicated for the control and prevention of bleeding episodes in adults and children with hemophilia A.

Probuphine (buprenorphine) Implant

Date of Approval: May 26, 2016
Company: Titan Pharmaceuticals, Inc.
Treatment for: Opiate Dependence

Probuphine (buprenorphine) is an opioid partial agonist subdermal implant for the treatment of opioid dependence.

Ocaliva (obeticholic acid) Tablets

Date of Approval: May 27, 2016
Company: Intercept Pharmaceuticals, Inc.
Treatment for: Biliary Cirrhosis

Ocaliva (obeticholic acid) is a first-in-class farnesoid X receptor (FXR) agonist for the treatment of primary biliary cholangitis.

Axumin (fluciclovine F 18) Injection

Date of Approval: May 27, 2016
Company: Blue Earth Diagnostics, Ltd.
Treatment for: Diagnostic

Axumin (fluciclovine F 18) a radioactive diagnostic agent indicated for positron emission tomography (PET) imaging in men with suspected recurrent prostate cancer.

Zinbryta (daclizumab) Injection

Date of Approval: May 27, 2016
Company: AbbVie, Inc. and Biogen
Treatment for: Multiple Sclerosis

Zinbryta (daclizumab) is an interleukin-2 receptor blocking antibody indicated for the treatment of relapsing forms of multiple sclerosis (MS).