NEW CHEMICAL ENTITIES
- DATSCAN
(IOFLUPANE I-123) by GE Healthcare
FDA Application number: NDA # 022454
Approval Date: 1/14/2011
DaTscan (Ioflupane I 123 Injection) is a radiopharmaceutical indicated for striatal dopamine transporter visualization using single photon emission computed tomography (SPECT) brain imaging to assist in the evaluation of adult patients with suspected Parkinsonian syndromes (PS). DaTscan may be used to help differentiate essential tremor from tremor due to PS (idiopathic Parkinson's disease, multiple system atrophy and progressive supranuclear palsy).
Prescribing Information:
http://us.datscan.com/wp-content/themes/main_site/pdf/prescribing-information.pdf - NATROBA
(SPINOSAD) by Parapro Pharmaceuticals
FDA Application number: NDA # 022408
Approval Date: 1/18/2011
Natroba™ Topical Suspension is a pediculicide indicated for the topical treatment of head lice infestations in patients four (4) years of age and older.
Prescribing Information:
http://www.natroba.com/Full%20Prescribing%20Information.pdf
- VIIBRYD
(VILAZODONE HYDROCHLORIDE) by Forest Labs
FDA Application number: NDA # 022567
Approval Date: 1/21/2011
VIIBRYD is indicated for the treatment of major depressive disorder (MDD).
Prescribing Information:
http://www.natroba.com/Full%20Prescribing%20Information.pdf FDA Application number: NDA # 200796 Approval Date: 2/25/2011
Edarbi is an angiotensin II receptor blocker indicated for the treatment of hypertension,to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. Edarbi may be used, either alone or in
combination with other antihypertensive agents.Prescribing Information:
http://general.takedapharm.com/content/file/pi.pdf?applicationcode=68E3872B-7993-4087-8929-05B4E4E0E6D2&FileTypeCode=EDARBIPI- DALIRESP
(ROFLUMILAST) by Forest Labs
FDA Application number: NDA # 022522
Approval Date: 2/28/2011
DALIRESP is indicated as a treatment to reduce the risk of COPD exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations.
Prescribing Information: http://www.frx.com/pi/Daliresp_pi.pdf
FDA Application number: NDA # 201277
Approval Date: 3/14/2011
GADAVIST™ is a gadolinium-based contrast agent indicated for intravenous use in diagnostic magnetic resonance imaging (MRI) in adults and children (2 years of age and older) to detect and visualize areas with disrupted blood brain barrier (BBB) and/or abnormal vascularity of the central nervous system.
Prescribing Information: http://labeling.bayerhealthcare.com/html/products/pi/gadavist_PI.pdf
- HORIZANT
(GABAPENTIN ENACARBIL) by Glaxo SmithKline
FDA Application number: NDA # 022399
Approval Date: 4/6/2011
HORIZANT is indicated for the treatment of moderate-to-severe primary Restless Legs Syndrome (RLS) in adults.
Prescribing Information: http://us.gsk.com/products/assets/us_horizant.pdf
- VANDETANIB
(VANDETANIB) by AstraZeneca
FDA Application number: NDA # 022405
Approval Date: 4/6/2011
CAPRELSA is a kinase inhibitor indicated for the treatment of symptomatic or progressive medullary thyroid cancer in patients with unresectable locally advanced or metastatic disease.
Prescribing Information: http://www.astrazeneca-us.com/cgi-bin/az_pi.cgi?product=caprelsa&country=us&popup=no
- ZYTIGA
(ABIRATERONE ACETATE) by Janssen Biotech
FDA Application number: NDA # 202379
Approval Date: 4/28/2011
ZYTIGA is a CYP17 inhibitor indicated for use in combination with prednisone for the treatment of patients with metastatic castration-resistant prostate cancer who have received prior hemotherapy containing docetaxel.
Prescribing Information: http://www.zytiga.com/downloads/full_product_information.pdf#zoom=100
- TRADJENTA
(LINAGLIPTIN) by Boehringer Ingleheim
FDA Application number: NDA # 201280
Approval Date: 5/2/2011
TRADJENTA is a dipeptidyl peptidase-4 (DPP-4) inhibitor indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus
Prescribing Information: http://bidocs.boehringer-ingelheim.com/BIWebAccess/ViewServlet.ser?docBase=renetnt&folderPath=/Prescribing+Information/PIs/Tradjenta/Tradjenta.pdf
FDA Application number: NDA # 202258
Approval Date: 5/13/2011
VICTRELIS is a hepatitis C virus (HCV) NS3/4A protease inhibitor indicated for the treatment of chronic hepatitis C (CHC) genotype 1 infection, in combination with peginterferon alfa and ribavirin, in adult patients (≥18 years of age) with compensated liver disease, including cirrhosis, who are previously untreated or who have failed previous interferon and ribavirin therapy.
Prescribing Information: http://www.merck.com/product/usa/pi_circulars/v/victrelis/victrelis_pi.pdf
FDA Application number: NDA # 202022
Approval Date: 5/20/2011
EDURANT® is a prescription HIV medicine that helps to treat HIV infection in adults. It contains the HIV drug rilpivirine. This is a type of HIV medicine called a non-nucleoside reverse transcriptase inhibitor, or NNRTI. EDURANT® is used in adults who have never taken HIV medicines before.
Prescribing Information: http://www.edurant-info.com/sites/default/files/EDURANT-PI.pdf
FDA Application number: NDA # 201917
Approval Date: 5/23/2011
INCIVEK is a hepatitis C virus (HCV) NS3/4A protease inhibitor indicated, in combination with peginterferon alfa and ribavirin, for the treatment of genotype 1 chronic hepatitis C (CHC) in adult patients with compensated liver disease, including cirrhosis, who are treatment-naïve or who have been previously treated with interferon-based treatment, including prior null responders, partial responders, and relapsers.
Prescribing Information:
http://pi.vrtx.com/files/uspi_telaprevir.pdf
FDA Application number: NDA # 201699
Approval Date: 5/27/2011
DIFICID is a macrolide antibacterial drug indicated in adults (18 years of age) for treatment of Clostridium difficile-associated diarrhea
Prescribing Information: http://www.dificid.com/upload/dificid.pdf
FDA Application number: NDA # 022345
Approval Date: 6/10/2011
POTIGA is a potassium channel opener indicated as adjunctive treatment of partial-onset seizures in patients aged 18 years and older.
Prescribing Information: http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022345s000lbl.pdf
- ARCAPTA NEOHALER
(INDACATEROL MALEATE) by Novartis
FDA Application number: NDA # 022383
Approval Date: 7/1/2011
ARCAPTA NEOHALER is a long-acting beta2-adrenergic agonist indicated for the long term, once-daily maintenance bronchodilator treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.
Prescribing Information: http://www.pharma.us.novartis.com/product/pi/pdf/arcapta.pdf
- XARELTO
(RIVAROXABAN) by Janssen Pharmaceticals
FDA Application number: NDA # 022406
Approval Date: 7/1/2011
XARELTO is a factor Xa inhibitor indicated to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation and for the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE) in patients undergoing knee or hip replacement.
surgery
Prescribing Information: http://www.xareltohcp.com/sites/default/files/pdf/xarelto_0.pdf#zoom=100
- BRILINTA
(TICAGRELOR) by Astra Zeneca
FDA Application number: NDA # 022433
Approval Date: 7/20/2011
BRILINTA is a P2Y12 platelet inhibitor indicated to reduce the rate of thrombotic cardiovascular events in patients with acute coronary syndrome (ACS) (unstable angina, non-ST elevation myocardial infarction, or ST elevation myocardial infarction). BRILINTA has been shown to reduce the rate of a combined endpoint of cardiovascular death, myocardial infarction or stroke compared to clopidogrel. The difference between treatments was driven by CV death and MI with no difference in stroke. In patients treated with PCI, it also reduces the rate of stent thrombosis.
Prescribing Information: http://www1.astrazeneca-us.com/pi/brilinta.pdf
FDA Application number: NDA # 202429
Approval Date: 8/17/2011
ZELBORAF™ is a kinase inhibitor indicated for the treatment of patients with unresectable or metastatic melanoma with BRAFV600E mutation as detected by an FDA-approved test.
Prescribing Information: http://www.gene.com/gene/products/information/zelboraf/pdf/pi.pdf
FDA Application number: NDA # 022150
Approval Date: 8/25/2011
FIRAZYR is a bradykinin B2 receptor antagonist indicated for the treatment of acute attacks of hereditary angioedema in adults 18 years of age and older.
Prescribing Information: http://pi.shirecontent.com/PI/PDFs/Firazyr_USA_ENG.pdf
FDA Application number: NDA # 202570
Approval Date: 8/26/2011
XALKORI is a kinase inhibitor indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) that is anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test. (1) This indication is based on response rate. There are no data available demonstrating improvement in patient reported outcomes or survival with XALKORI.
Prescribing Information: http://labeling.pfizer.com/showlabeling.aspx?id=676
FDA Application number: NDA # 021825
Approval Date: 10/14/2011
FERRIPROX® (deferiprone) is an iron chelator indicated for the treatment of patients with transfusional iron overload due to thalassemia syndromes when current chelation therapy is inadequate.
Prescribing Information: http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021825lbl.pdf
FDA Application number: NDA # 202067
Approval Date: 10/21/2011
ONFI is a benzodiazepine indicated for adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in patients 2 years of age or older
Prescribing Information: http://www.lundbeck.com/upload/us/files/pdf/Products/Onfi_PI_US_EN.pdf
FDA Application number: NDA # 202192
Approval Date: 11/16/2011
Jakafi is a kinase inhibitor indicated for treatment of patients with intermediate or high-risk myelofibrosis, including primary myelofibrosis, post-polycythemia vera myelofibrosis and post-essential thrombocythemia myelofibrosis.
Prescribing Information: http://www.incyte.com/products/uspi_jakafi.pdf
BIOLOGICS
- BENLYSTA
(BELIMUMAB) by Human Genome Sciences ($HGSI)
FDA Application number: BLA # 125370
Approval Date: 3/10/2011
BENLYSTA is a B-lymphocyte stimulator (BLyS)-specific inhibitor indicated for the treatment of adult patients with active, autoantibody-positive, systemic lupus erythematosus
Prescribing Information: http://www.hgsi.com/images/Benlysta/pdf/benlysta_pi.pdf
- YERVOY
(IPILIMUMAB) by Bristol Myers Squibb ($BMS)
FDA Application number: BLA # 125377
Approval Date: 3/25/2011
YERVOY is a human cytotoxic T-lymphocyte antigen 4 (CTLA-4)-blocking antibody YERVOY is a human cytotoxic T-lymphocyte antigen 4 (CTLA-4)-blocking antibody indicated for the treatment of unresectable or metastatic melanoma.
Prescribing Information: http://packageinserts.bms.com/pi/pi_yervoy.pdf
- NULOJIX
(BELATACEPT) by Bristol Myers Squibb ($BMS)
FDA Application number: BLA # 125288
Approval Date: 6/15/2011
NULOJIX is a selective T-cell costimulation blocker indicated for prophylaxis of organ rejection in adult patients receiving a kidney transplant.
Prescribing Information: http://packageinserts.bms.com/pi/pi_nulojix.pdf
- ADCETRIS
(BRENTUXIMAB VEDOTIN) by Seattle Genetics ($SGEN)
FDA Application number: BLA # 125399
Approval Date: 8/19/2011
ADCETRIS is a CD30-directed antibody-drug conjugate indicated for:
• The treatment of patients with Hodgkin lymphoma (HL) after failure of autologous stem cell transplant (ASCT)
•HL in patients who are not ASCT candidates after failure of at least 2 multiagent chemotherapy regimens
• Systemic anaplastic large cell lymphoma (sALCL) after failure of at least 1 multiagent chemotherapy regimen
Prescribing Information: http://www.adcetris.com/_pdf/Adcetris_USPI_2011.pdf
- ERWINAZE
(asparaginase Erwinia chrysanthemi) by Eusa Pharmaceuticals
FDA Application number: BLA # 125359
Approval Date: 11/18/2011
ERWINAZE (asparaginase Erwinia chrysanthemi) is an asparagine-specific enzyme indicated as a component of a multi-agent chemotherapeutic regimen for the treatment of patients with acute lymphoblastic leukemia (ALL) who have developed hypersensitivity to E. coli derived asparaginase.
Prescribing Information: http://www.erwinaze.com/pdf/PI_18-Nov2011.pdf
FDA Application number: BLA # 125387
Approval Date: 11/18/2011
EYLEA is indicated for the treatment of patients with Neovascular (Wet) Age-Related Macular Degeneration (AMD).
Prescribing Information: http://www.regeneron.com/EYLEA-fpi.pdf
