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New Drug Approvals Archive - May 2016

May 2016

May 2	Trintellix (vortioxetine) Labeling Revision Approved: May 2, 2016 Brintellix (vortioxetine) Renamed Trintellix (vortioxetine) in U.S. to Avoid Name Confusion Trintellix (vortioxetine) FDA Approval History
May 2	Fycompa (perampanel) New Dosage Form Approved: May 2, 2016 Eisai Announces FDA Approval of Fycompa (perampanel) Oral Suspension Fycompa (perampanel) FDA Approval History
May 9	Vibativ (telavancin) Labeling Revision Approved: May 6, 2016 Theravance Biopharma Announces FDA Approval of Expanded Label for Vibativ (telavancin) Vibativ (telavancin) FDA Approval History
May 9	Imbruvica (ibrutinib) New Indication Approved: May 6, 2016 Treatment for: Mantle Cell Lymphoma; Chronic Lymphocytic Leukemia; Waldenström’s Macroglobulinemia; Small Lymphocytic Lymphoma; Marginal Zone Lymphoma U.S. FDA Expands Imbruvica (ibrutinib) Label to Include Overall Survival Data in Previously Untreated Chronic Lymphocytic Leukemia (CLL) and New Indication for Small Lymphocytic Lymphoma (SLL) Patients Imbruvica (ibrutinib) FDA Approval History
May 10	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
May 13	Lenvima (lenvatinib) New Indication Approved: May 13, 2016 FDA Approves Lenvima (lenvatinib) for the Treatment of Patients with Advanced Renal Cell Carcinoma Lenvima (lenvatinib) FDA Approval History
May 17	Opdivo (nivolumab) New Indication Approved: May 17, 2016 Opdivo (nivolumab) FDA Approved for the Treatment of Hodgkin Lymphoma Opdivo (nivolumab) FDA Approval History
May 18	Tecentriq (atezolizumab) Injection Date of Approval: May 18, 2016 Company: Genentech, Inc. Treatment for: Bladder Cancer, Non-Small Cell Lung Cancer Tecentriq (atezolizumab) is a programmed death-ligand 1 (PD-L1) blocking antibody indicated for the treatment of patients with advanced urothelial carcinoma and patients with metastatic non-small cell lung cancer (NSCLC). FDA Approves Tecentriq (atezolizumab) for Urothelial Carcinoma Tecentriq (atezolizumab) FDA Approval History
May 24	Invokamet (canagliflozin and metformin) Labeling Revision Approved: May 20, 2016 FDA Expands Indication of Invokamet (canagliflozin/metformin HCl) to Include First-Line Treatment of Type 2 Diabetes Invokamet (canagliflozin and metformin) FDA Approval History
May 25	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. FDA Approves Afstyla (Antihemophilic Factor (Recombinant), Single Chain) for Hemophilia A Afstyla (antihemophilic factor (recombinant), single chain) FDA Approval History
May 26	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. FDA Approves Probuphine (buprenorphine) Implant for Treatment of Opioid Dependence Probuphine (buprenorphine) FDA Approval History
May 27	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. FDA Grants Accelerated Approval to Ocaliva (obeticholic acid) for Primary Biliary Cholangitis Ocaliva (obeticholic acid) FDA Approval History
May 27	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. FDA Approves Axumin (fluciclovine F 18) Diagnostic Imaging Agent to Detect Recurrent Prostate Cancer Axumin (fluciclovine F 18) FDA Approval History
May 27	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). FDA Approves Zinbryta (daclizumab) to Treat Multiple Sclerosis Zinbryta (daclizumab) FDA Approval History
May 31	Teflaro (ceftaroline fosamil) Patient Population Altered: May 27, 2016 Allergan Receives FDA Approval of Teflaro (ceftaroline fosamil) for Pediatric Patients Teflaro (ceftaroline fosamil) FDA Approval History
May 31	Jentadueto (linagliptin and metformin hydrochloride) New Formulation Approved: May 31, 2016 FDA Approves Once-Daily Jentadueto XR (linagliptin and metformin hydrochloride extended-release) for Type 2 Diabetes Jentadueto (linagliptin and metformin hydrochloride) FDA Approval History
October 18	Tecentriq (atezolizumab) New Indication Approved: October 18, 2016 FDA Approves Genentech’s Cancer Immunotherapy Tecentriq (Atezolizumab) for People with a Specific Type of Metastatic Lung Cancer Tecentriq (atezolizumab) FDA Approval History
April 17	Tecentriq (atezolizumab) New Indication Approved: April 17, 2017 FDA Grants Genentech’s Tecentriq (atezolizumab) Accelerated Approval as Initial Treatment for Certain People with Advanced Bladder Cancer Tecentriq (atezolizumab) FDA Approval History

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