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Original New Drug Applications New Drugs Reviewed by CPG January 23, 2017 (Original New Drug Applications: FDA) Generic Name Trade Name Indication(s) CPG Action Immune globulin Cuvitru Biologic and In accordance with subcutaneous Immunological the SCA [human] 20% solution Agents/Immune Globulins/ Immune Globulin (Human) subcutaneous. Indicated as replacement for primary humoral immunodeficiency in adult and pediatric patients age two and older. eteplirsen Exondys 51 Central Nervous System In accordance with Agents/Antisense the SCA Oligonucleotides. Treatment of patients who have a confirmed mutation of the dystrophin gene amenable to exon 51 skipping. First drug approved for reatment of patients with Duchenne muscular dystrophy. levonorgestrel- Kyleena Endocrine and May prescribe releasing intrauterine Metabolic Agents/sex system 19.5 mg homones/contraceptive Hormones. Prevention of pregnancy for up to five years. **Phentermine Lomaira Central Nervous System In accordance with hydrochloride 8 mg Agents/ the SCA anorexiants/sympathomi metic anorexiants. Short term use weight reduction in adults with **(new formulation at an initial BMI of 30 or lower dosage) more or 27 with at least one weight-related condition. 1 New Drugs January 2017 canaglifozin/ Invokamet XR Endocrine and May prescribe metformin HCL Metabolic Agents/ extended-release antidiabetic agents/antidiabetic combination products. Treatment of adults with type 2 diabetes as an adjunct to diet and exercise. Adalimumab-atto Amjevita Biologic and In accordance with Immunological Agents/ the SCA Immunologic Agents/Immunomodulat ors/Tumor necrosis Factor-Alpha Blockers. Indicated for treatment of adults with: rheumatoid arthritis, psoriatic arthritis,ankylosing spondylitis, Crohn disease, ulcerative colitis, and plaque psoriasis. Also indicated for juvenile idiopathic arthritis in pts age 4 years and older. Flublok Quadravalent Biologic and May prescribe Immunological Agents/agents for active immunization/vaccines, viral. Protects against 4 straing of influence, 3 of the same strains found in trivalent Flublok as well as an additional B strain. Approved for adults age 18 and older. 2 New Drugs January 2017 olaratumab Lartuvo Antineoplastic May not prescribe Agents/monoclonal antibodies. For use in combination with doxorubicin for the treatment of adult patients with soft tissue sarcoma with a histologic subtype for which an anthracycline- containing regiment is appropriate and which is not amenable to curative treatment with radiotherapy or surgery. bezlotoxumab Zinplava Biologic and May prescribe Immuniclogical Agents/ monocolonal antibodies (biologic/immunologic). Reduces recurrence of C-diff infection in patients age 18 and older who are receiving antibacterial drug treatment of C-diff an are at high risk for recurrence. tenofovir alafenamide Vemlidy Anti-infective Agents/ May prescribe antiretroviral agents/nucleotide analog reverse transcriptase inhibitors. Treatment of chronic hepatitis B infection in adults with compensated liver disease. DHEA Intrarosa Endocrine and May prescribe Metabolic Agents/ sex homones. Treatment of postmenopausal moderate to severe dyspareunia. 3 New Drugs January 2017 Insulin Soliqua Endocrine and May prescribe glargine/lixisenatide Metabolic Agents/antidiabetic agents/insulin combination. Adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes inadequately controlled on basal insulin or lixisenatide. SMOFlipid Nutrients and Nutritional May prescribe Agents/intravenous nutritional therapy/lipids. Source of calories, essential fatty acids, and omega-3 fatty acids for adults requiring parenteral nutrition. Eucrisa Crisaborole 2% Dermatological agents/ May prescribe phosphodiesterase-4 inhibitors. Topical treatment of mild to moderate atopic dermatitis in patients age 2 years and older. rucaparib Rubraca Antineoplastic In accordance with Agents/PARP Enzymes the SCA Inhibitor. Approved for treatment of ovarian cancer. nusinersen Spinraza Central Nervous System In accordance with Agents/Antisense the SCA Oligonucleotides. Treatment of spinal muscular atrophy. 4 New Drug Indications/ Warnings Reviewed by CPG January 23, 2017 (New Drug Indications/ Boxed Warnings: FDA) Generic Name Trade Name Therapeutic Category CPG Action canakinumab Ilaris Biologic and Immunological Current: In Agents; immunologic agents; accordance with the (expanded indication) immunomodulators SCA January 23, 2017: No change ustekinumab Stelara Biologic and Immunological Current: In Agents;immunologic agents; accordance with the immunomodulators SCA (expanded indication) January 23, 2017: No change idelalisib Zydelig Antineoplastic Agents; Kinase Current: May not Inhibitors; phosphatidylinositol 3- prescribe (expanded black box kinase inhibitors warning) January 23, 2017: No change lumacaftor/ Orkambi Endocrine and Metabolic Agents; Current: In ivacaftor cystic fibrosis transmembrane accordance with the regulator protein SCA (expanded indication) January 23, 2017: No change eltrombopag Promacta Hemotologic Agents; Current: In hematopoietic agents; accordance with the (expanded boxed thrombopoietin receptor agonist SCA warning) January 23, 2017: No change atezolizumab Tecentriq Antineoplastic agents; monoclonal Current: May not (expanded indication) antibodies (antineoplastic) prescribe January 23, 2017: No change paricalcitol Zemplar Nutrients and Nutritional Agents; Current: May vitamins; fat-soluble vitamins; prescribe (expanded indication) vitamin D January 23, 2017: No change 1 New Drug Indications January 2017 pembrolizumab Keytruda Biologic and Immunological Current: May not Agents; immunologic agents; prescribe (expanded indication) immunomodulators January 23, 2017: No change etanercept Enbrel Biologic and Immunological Current: In Agents; immunologic agents; accordance with the immunomodulators; tumor SCA (expanded indication) necrosis factor-alpha blockers (TNF-alpha blockers) January 23, 2017: No change daratumumab Darzalex Antineoplastic Agents; Current: May not monoclonoal antibodies prescribe (expanded indication) (antineoplastic) January 23, 2017: No change flu vaccine FluLaval Biologic and Immunological Current: May Quadrivalent Agents/ Agents for Active prescribe (expanded indication) Immunization/vaccine, viral. January 23, 2017 No change sevelamer carbonate Renvela Renal and Genitourinary Agents/ Current: May Phosphate Binders. prescribe (expanded indication) January 23, 2017: No change empagliflozin Jardiance Endcrine and Metabolic Agents/ Current: May Antidiabetic Agents/ sodium- prescribe glucose co-transporter 2 (expanded indication) inhibitors. January 23, 2017: No change hyaluronic acid Restylane Central Nervous System Agents/ Current: May Refyne physical adjuncts/hyaluronic acid prescribe derivatives, dermal. (expanded indication) January 23, 2017: No change hyaluronic Acid Restylane Central Nervous System Agents/ Current: May Defyne physical adjuncts/hyaluronic acid prescribe derivatives, dermal. (expanded indication) January 23, 2017: No change degludec and Tresiba and Endocrine and Metabolic Agents/ Current: May degludec/insulin Ryzodeg 70/30 Antidiabetic Agents/Insulin. prescribe aspart (expanded indication) January 23, 2017: No change 2 New Drug Indications January 2017 chlorazepate Tranxene T- Central Nervous System Agents/ Current: may dipotassium Tab Benzodiazepines. prescribe (boxed warning) January 23, 2017: No change temazepam Restoril Central Nervous System Agents/ Current: May Benzodiazepines. prescribe (boxed warning) January 23, 2017: No change tramadol Utram Central Nervous System Agents/ Current: May hydrochloride Opioid Analgesics. prescribe (boxed warning) January 23, 2017: No change antihemophilic factor Adynovate Hemotological Current: In [recombinant], Agents/Antihemophilic accordance with the pegolated Agents/Antihemophilic Factor SCA (Factor VIII:AHF). (expanded indication) January 23, 2017: No change nalbuphine Nubain Central Nervous System Agents/ Current: May hydrochloride Opioid Agonist-Antagonist prescribe Analgesics. (boxed warning) January 23, 2017: No change Diazepam Valium Central Nervous System Agents/ Current: May Benzodiazepines. prescribe (boxed warning) January 23, 2017: No change oxymorphone Opana Central Nervous System Current: Subject to hydrochloride Agents/Opioid Analgesics. Schedule II restrictions/ (expanded indication) formulary January 23, 2017: No change fentanyl citrate Fentanyl Central Nervous System Current: Subject to Agents/Opioid Analgesics. Subject to Scheduel (boxed warning) II restrictions/ formulary January 23, 2017: No change pentazocine Talwin Central Nervous System Agents/ Current: May Opioid Agonist-Antagonist prescribe (boxed warning) Analgesics. January 23, 2017: No change 3 New Drug Indications January 2017 Merperidine Demerol Central Nervous System Agents/ Current: subject to hydrochloride Opioid Analgesics. Schedule II prescribing (boxed warning) restrictions/ formulary January 23, 2017: No change chlordizepoxide Librium Central Nervous System Agents/ Current: May hydrochloride Benzodiazepines. prescribe (boxed warning) January 23, 2017: No change empaglifozin/ Glyxambi Endocrine and Metabolic Agents/ Current: May Linagliptin Antidiabetic Agents/ Antidiabetic prescribe Combination products. (expanded indication) January 23, 2017: No change Sufentanil citrate Central Nervous System Current: subject to Agents/Opioid Analgesics. schedule II (boxed warning) prescribing restrictions/ formulary January 23, 2017: No change oxycodone Percodan Central Nervous System Current: subject
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