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3 Aug 2015

20 New Molecular Entity and New Therapeutic Biological Product Approvals for 2015 till date

No. Drug Active Ingredient FDA-approved use on approval date
20 Daklinza daclatasvir To treat hepatitis C virus (HCV) genotype 3 infections
19 Odomzo sonidegib To treat patients with locally advanced basal cell carcinoma that has recurred following surgery or radiation therapy, or who are not candidates for surgery or radiation therapy.
18 Praluent alirocumab To treat certain patients with high cholesterol
17 Rexulti brexpiprazole To treat schizophrenia and as an add on to an antidepressant to treat major depressive disorder
16 Entresto sacubitril/valsartan To treat heart failure
15 Orkambi lumacaftor 200 mg/ivacaftor 125 mg To treat cystic fibrosis
14 Kengreal canegrelor To prevent the formation of harmful blood clots in the coronary arteries for adult patients undergoing percutaneous coronary intervention
13 Viberzi eluxadoline To treat irritable bowel syndrome with diarrhea (IBS-D) in adult men and women.
12 Kybella deoxycholic acid To treat adults with moderate-to-severe fat below the chin, known as submental fat
11 Corlanor ivabradine To reduce hospitalization from worsening heart failure.
10 Cholbam cholic acid To treat pediatric and adult patients with bile acid synthesis disorders due to single enzyme defects, and for patients with peroxisomal disorders
9 Unituxin dinutuximab To treat pediatric patients with high-risk neuroblastoma
8 Cresemba isavuconazonium sulfate To treat adults with invasive aspergillosis and invasive mucormycosis, rare but serious infections
7 Avycaz ceftazidime-avibactam To treat adults with complicated intra-abdominal infections (cIAI), in combination with metronidazole, and complicated urinary tract infections (cUTI), including kidney infections (pyelonephritis), who have limited or no alternative treatment options.
6 Farydak panobinostat To treat patients with multiple myeloma
5 Lenvima lenvatinib To treat patients with progressive, differentiated thyroid cancer (DTC) whose disease progressed despite receiving radioactive iodine therapy (radioactive iodine refractory disease).
4 Ibrance palbociclib To treat advanced (metastatic) breast cancer
3 Natpara parathyroid horomone To control hypocalcemia (low blood calcium levels) in patients with hypoparathyroidism
2 Cosentyx secukinumab To treat adults with moderate-to-severe plaque psoriasis
1 Savaysa edoxaban To reduce the risk of stroke and dangerous blood clots (systemic embolism) in patients with atrial fibrillation that is not caused by a heart valve problem

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