New Drug Approvals Archive - May 2016
See also: New Indications and Dosage Forms for May 2016
May 2016
Flucelvax Quadrivalent (influenza virus vaccine, inactivated)
Date of Approval: May 23, 2016
Company: Seqirus
Treatment for: Influenza Prophylaxis
Flucelvax Quadrivalent is an inactivated influenza vaccine indicated for active immunization for active immunization against influenza disease in people 4 years of age and older.
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.
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, Hepatocellular Carcinoma, Melanoma -- Metastatic
Tecentriq (atezolizumab) is a programmed death-ligand 1 (PD-L1) blocking antibody indicated for use in the treatment of urothelial carcinoma, non-small cell lung cancer (NSCLC), triple-negative breast cancer (TNBC), small cell lung cancer (SCLC), heptatocellular carcinoma and melanoma.
Flucelvax Quadrivalent (influenza virus vaccine, inactivated)
Date of Approval: May 23, 2016
Company: Seqirus
Treatment for: Influenza Prophylaxis
Flucelvax Quadrivalent is an inactivated influenza vaccine indicated for active immunization for active immunization against influenza disease in people 4 years of age and older.
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).
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