24
Apr
2015
10 New Molecular Entity approved by USFDA in 2015 till date
As on that 10 new molecular entity is approved by USFDA.
| No. | Drug | Active Ingredient | FDA-approved use on approval date |
| 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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