New Drug Approvals Archive - May 2016

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

Fycompa (perampanel)

New Dosage Form Approved: May 2, 2016

• Eisai Announces FDA Approval of Fycompa (perampanel) Oral Suspension
• Fycompa (perampanel) FDA Approval History

Vibativ (telavancin)

Labeling Revision Approved: May 6, 2016

• Theravance Biopharma Announces FDA Approval of Expanded Label for Vibativ (telavancin)
• Vibativ (telavancin) FDA Approval History

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; Chronic Graft Versus Host Disease

• 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

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

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

Opdivo (nivolumab)

New Indication Approved: May 17, 2016

• Opdivo (nivolumab) FDA Approved for the Treatment of Hodgkin Lymphoma
• Opdivo (nivolumab) FDA Approval History

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

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

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

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

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

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

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

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

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

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

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