HORIZON LINES: A QUARTERLY REVIEW OF NDAs SECTION TITLE
Approval date (2014)
August 15
August 19 August 20
August 21 August 25 August 26 August 25 September 4 September 5 September 10 September 16 September 18 September 22 September 23 September 24
September 24 September 24
September 25 September 26 September 29 September 29
Trade Name Plegridy Cerdelga Arnuity Ellipta Eliquis Zorvolex Promacta Kabiven Keytruda* Auryxia Contrave Movantik Trulicity Triumeq Otezla* Minivelle
Vitekta Tybost
Spiriva Respimat
Iluvien Abilify
Maintena Ozurdex
Drug Name Peginterferon beta-1a Eliglustat Fluticasone furoate Apixaban Diclofenac Eltrombopag
Amino acids, electrolytes, dextrose and lipid
Pembrolizumab Ferric citrate
Bupropion and naltrexone
Naloxegol Dulaglutide
Abacavir, Dolutegravir, and Lamivudine
Apremilast Estradiol
Elvitegravir Cobicistat
Tiotropium bromide Fluocinolone acetonide
Aripiprazole, 300 mg and 400 mg
Dexamethasone
Dosage Form
Subcutaneous injection pen
Capsules Inhalation powder Tablet Capsules Tablets IV infusion Injection Tablets Tablets Tablets Injection pen Tablet Tablets
Company Biogen Idec
Genzyme Corporation GlaxoSmithKline plc Bristol-Myers
Squibb Company Iroko Pharmaceuticals, LLC GlaxoSmithKline Fresenius Kabi USA Merck & Co., Inc. Keryx Biopharmaceuticals Orexigen Therapeutics, Inc. AstraZeneca
Pharmaceuticals LP Eli Lilly and Company
ViiV health care Celgene Corporation
Indication
Relapsing forms of multiple sclerosis
Gaucher disease (Type 1) Asthma and its maintenance
Deep vein thrombosis and pulmonary embolism
Management of osteoarthritis pain
Severe aplastic anemia Parenteral nutrition Metastatic melanoma
Hyperphosphatemia of renal failure
Obesity
Opioid-induced constipation, alcohol addiction
Type 2 diabetes HIV infection
Plaque psoriasis and psoriatic arthritis
Transdermal patch Noven Pharmaceuticals Inc. Postmenopausal osteoporosis and hot flashes
Tablets Tablets
Inhalation spray* Intravitreal Implant
Dual chamber syringe*
Intravitreal injection
Gilead Sciences Inc. Gilead Sciences Inc.
Boehringer Ingelheim Pharmaceuticals, Inc.
Alimera Sciences, Inc.
Otsuka Pharmaceutical Co., Ltd.
Allergan Inc.
HIV infection HIV infection
Bronchospasm associated with COPD
Diabetic macular edema Schizophrenia Diabetic macular edema*
Zydelig was submitted with 2 indications, of which 1 was granted a Breakthrough Therapy, Fast Track, and Priority Review. The other indication was granted an Accelerated approval. * Drugs First in Class Bold trade names are novel new drugs. # Prices are highly variable and depend on various factors.
Price# $4900/2 pens
$23,800/28-day supply $145/inhaler
$1000/180 tablets $260/90 capsules $3000/30 tablets N/A $6600/3 vials (50 mg) $750/200 tablets $215/120 tablets N/A $525/carton $2260/30 tablets $2000/60 tablets (30 mg) $110/8 patches (0.1 mg)
$1230/30 tablets N/A
$320/inhaler N/A $1625/vial N/A
pharmoutsourcing.com | 61 | March/April 2015
Page 1 |
Page 2 |
Page 3 |
Page 4 |
Page 5 |
Page 6 |
Page 7 |
Page 8 |
Page 9 |
Page 10 |
Page 11 |
Page 12 |
Page 13 |
Page 14 |
Page 15 |
Page 16 |
Page 17 |
Page 18 |
Page 19 |
Page 20 |
Page 21 |
Page 22 |
Page 23 |
Page 24 |
Page 25 |
Page 26 |
Page 27 |
Page 28 |
Page 29 |
Page 30 |
Page 31 |
Page 32 |
Page 33 |
Page 34 |
Page 35 |
Page 36 |
Page 37 |
Page 38 |
Page 39 |
Page 40 |
Page 41 |
Page 42 |
Page 43 |
Page 44 |
Page 45 |
Page 46 |
Page 47 |
Page 48 |
Page 49 |
Page 50 |
Page 51 |
Page 52 |
Page 53 |
Page 54 |
Page 55 |
Page 56 |
Page 57 |
Page 58 |
Page 59 |
Page 60 |
Page 61 |
Page 62 |
Page 63 |
Page 64 |
Page 65 |
Page 66 |
Page 67 |
Page 68 |
Page 69 |
Page 70 |
Page 71 |
Page 72 |
Page 73 |
Page 74 |
Page 75 |
Page 76 |
Page 77 |
Page 78