美国FDA认证的所有材料的目录？New Molecular Entity and New Therapeutic Biological Product Approvals for 2015 No. Drug Name Active Ingredient Date FDA-approved use on approval date 10. Cholbam cholic acid 3/17/2015 To treat pediatric and adult patients with bile acid synthesis disorders due to single enzyme defects, and for patients with peroxisomal disorders Press Release 9. Unituxin dinutuximab 3/10/2015 To treat pediatric patients with high-risk neuroblastoma Press Release 8. Cresemba capsule injection isavuconazonium sulfate 3/6/2015 To treat adults with invasive aspergillosis and invasive mucormycosis, rare but serious infections Press Release 7. Avycaz ceftazidime-avibactam 2/25/2015 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. Press Release 6. Farydak panobinostat 2/23/2015 To treat patients with multiple myeloma Press Release 5. Lenvima lenvatinib 2/13/2015 To treat patients with progressive, differentiated thyroid cancer (DTC) whose disease progressed despite receiving radioactive iodine therapy (radioactive iodine refractory disease). Press Release 4. Ibrance palbociclib 2/3/2015 To treat advanced (metastatic) breast cancer Press Release 3. Natpara parathyroid horomone 1/23/2015 To control hypocalcemia (low blood calcium levels) in patients with hypoparathyroidism Press Release 2. Cosentyx secukinumab 1/21/2015 To treat adults with moderate-to-severe plaque psoriasis Press Release 1. Savaysa edoxaban 1/8/2015 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 Press Release查看更多
求助默克索引 ：Nicorandil CAS Registry Number: 65141？Monograph number: 06521 Title: Nicorandil CAS Registry Number: 65141-46-0 CAS Name: N--3-pyridinecarboxamide Additional Names: N-(2-hydroxyethyl)nicotinamide nitrate (ester) Manufacturers' Codes: SG-75 Trademarks: Adancor (Merck-Clévenot); Ikorel (RPR); Perisalol (Chugai); Sigmart (Chugai) Molecular Formula: C8H9N3O4 Molecular Weight: 211.17 Percent Composition: C 45.50%, H 4.30%, N 19.90%, O 30.31% Literature References: Nicotinamide derivative; exhibits dual mechanism of action as both nitrovasodilator and potassium channel activator. Prepn: H. Nagano et al., DE 2714713; eidem, US 4200640 (1977, 1980 both to Chugai). Pharmacology: N. Taira et al., Clin. Exp. Pharmacol. Physiol. 6, 301 (1979) DOI PMID . Mechanism of action: F. Yoneyama et al., Cardiovasc. Drugs Ther. 4, 1119 (1990) DOI PMID . Symposia on pharmacology and clinical efficacy: Am. J. Cardiol. 63, Suppl, 1J-85J (1989); J. Cardiovasc. Pharmacol. 20, Suppl. 3, S1-S108 (1992). Review of clinical potential in ischemic heart disease: H. Purcell, K. Fox, Br. J. Clin. Pract. 47, 150-154 (1993) PMID . Clinical prevention of coronary events in patients with angina: IONA Study Group, Lancet 359, 1269 (2002) DOI PMID . Properties: Colorless needles from ether/ethanol, mp 92-93°. LD50 in rats (mg/kg): 1200-1300 orally; 800-1000 i.v. (Nagano).查看更多
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