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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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