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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