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Final RX OPOE List for posting June 2023 XLS
… SODIUM GLYCEROPHOSPHATE; SOYBEAN OIL N200656 EMULSION AMPHOTERICIN B N050724 INJECTABLE, LIPID COMPLEX ATAZANAVIR SULFATE …
Final RX OPOE List for posting December 2022 XLS
… SODIUM GLYCEROPHOSPHATE; SOYBEAN OIL N200656 EMULSION AMPHOTERICIN B N050724 INJECTABLE, LIPID COMPLEX ATAZANAVIR SULFATE …
Bulk Drug Substances Nominated for Use in Compounding Under Section 503B of the Federal Food, Drug, and Cosmetic Act
… Drug Substances List Additions to category 3: • Vitamin B Complex Revisions to category 3: • FDA will modify the … Hydrochloride** • Amitriptyline Hydrochloride** • Amphotericin B** • Anastrozole** 2 A condition of section 503B of the FD&C …
Curriculum Vitae: Jennifer Le
… Present 2010 2011 jenle@health.ucsd.edu | (858) 534 - 3692 B O A R D C E R T I F I C A T I O N BASIC CARDIAC LIFE … 2003 2004 2005 2006 2008 2009 2013 2014 2015 2016 M E M B E R S H I P 1998 – 2015 1998 – 2010 2000 – Present 2001 – … | (858) 534 - 3692 Safety and Tolerability of Amphotericin B Use in Neonates, Principal Investigator of …
Curriculum Vitae: Jennifer Le
… Present 2010 2011 jenle@health.ucsd.edu | (858) 534 - 3692 B O A R D C E R T I F I C A T I O N BASIC CARDIAC LIFE … 2003 2004 2005 2006 2008 2009 2013 2014 2015 2016 M E M B E R S H I P 1998 – 2015 1998 – 2010 2000 – Present 2001 – … | (858) 534 - 3692 Safety and Tolerability of Amphotericin B Use in Neonates, Principal Investigator of …
Epicel Summary of Safety and Probable Benefit
… (and if clinically indicated from the patient’s history, amphotericin B is added). Trace quantities of these anti-infective agents … response. 2 http://origin.www.fda.gov/cber/xap/trans.htm B. Precautions Caution: Do not use Epicel® past its …
Paul M. Beringer, Pharm.D. CV
… Best Student Poster Presentation ' Student: Tim Bensman, B.S., Pharm.D. candidate ' 2009 ' AFPE Post-PharmD Fellowship … Chemother 2016;71:181-188. PMID: 26433781 Ha H, Debnath B, Odde S, Bensman T, Ho H, Beringer PM, and Neamati N. … A. Nebulizer choice affects the airway targeting of amphotericin B lipid complex aerosols. J Pharm Technol …
062018 List of Off Patient Off Exclusivity Drugs with no approved generic XLS
… AMOXICILLIN; CLAVULANATE POTASSIUM N050575 FOR SUSPENSION AMPHOTERICIN B N050740 INJECTABLE, LIPOSOMAL APOMORPHINE HYDROCHLORIDE … HYDROCORTISONE ACETATE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE N050218 CREAM HYDROCORTISONE PROBUTATE N020453 …
122017 List of Off Patient Off Exclusivity Drugs with no approved generic XLS
… N050824 CAPSULE, TABLET, CAPSULE, DELAYED RELEASE AMPHOTERICIN B N050740 INJECTABLE, LIPOSOMAL APOMORPHINE HYDROCHLORIDE … HYDROCORTISONE ACETATE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE N050218 CREAM HYDROCORTISONE PROBUTATE N020453 …
GRAS Notice 938
… procedures, in accordance with 21 CFR 170.30 (a) and (b). 4 GRAS determination of Pichia kluyveri DSM 33235 … ≤0.008 0.064 0.064 ≥1 Micafungin ≤0.008 - 0.25 ≥1 Polyenes Amphotericin 0.06 1 1 - Pyrimidine analogue Flucytosine 2 - - … in as listed Table v. 9.0 valid from 2018-02-12. B: EUCAST ECOFF for Candida krusei (P. kudriavzevii) given at …
Paul M. Beringer Curriculum Vitae 032222
… Best Student Poster Presentation Student: Tim Bensman, B.S., Pharm.D. candidate March 3, 2022 Paul M. Beringer, … Chemother 2016;71:181-188. PMID: 26433781 Ha H, Debnath B, Odde S, Bensman T, Ho H, Beringer PM, and Neamati N. … A. Nebulizer choice affects the airway targeting of amphotericin B lipid complex aerosols. J Pharm Technol …
DILIst Supplementary Table
… 1 Oral 23 amiodarone 1 Oral 24 amitriptyline 1 Oral 25 amphotericin b 1 Intravenous 26 ampicillin 1 Oral 27 donepezil 1 Oral 28 … mofetil 1 Oral 614 cefdinir 1 Oral 615 polymyxin b sulfate 0 Intravenous 616 diltiazem 1 Oral 617 sterile …
List of Off-Patent, Off-Exclusivity Drugs without an Approved Generic
… via the 505(j) pathway may not be appropriate; section 505(b)(2) of the FD&C Act may be an appropriate abbreviated … AMOXICILLIN; CLAVULANATE POTASSIUM 050575 FOR SUSPENSION AMPHOTERICIN B 050740 INJECTABLE, LIPOSOMAL APOMORPHINE HYDROCHLORIDE …
Drug and Biologic Essential Medicines, Medical Countermeasures, and Critical Inputs for the List Described in Section 3(c) of the Executive Order 13944
… Category: Anti-Microbial Amikacin IV API only (blank cell) Amphotericin B IV API, + (blank cell) Ampicillin IV API only (blank cell) … with recombinant botulinum vaccine for serotypes A and B (blank cell) Rabies immune globulin IV Plasma from human …
MDP 2022 Curriculum Vitae Thomas Moore
… Graduate: Postgraduate: Washington University; B.A. (Classics), B.A. (Biology) The University of Kansas School of Medicine, … Efficacy and Safety of NYOTRAN (Liposomal Nystatin) and Amphotericin B for Empiric Antifungal Treatment in …
February 15, 2024 Summary Basis for Regulatory Action - AMTAGVI
… 6 b. Testing Specifications … 14 b. Bioresearch Monitoring (BIMO) – … 18 b. Benefit/Risk Assessment … manufacturing change. 2. Background Disease Background (b) (4) (b) (4) (b) (4) (b) (4) (b) (4) (b) (4)(b) (4) 5 Data … residual antibiotics (i.e., gentamicin, streptomycin, and amphotericin B) Through process validation, the level of each …
D1S04-Manheng
… Macular degeneration Drug delivery 1997 AmBisome Liposome Amphotericin B Antifungal Drug delivery 1996 Taxotere Micelle Docetaxel … liposome injection) This NDA was submitted as a 505 (b)(2) application (Reference drugs: DepoCyt ® and DaunoXome …
GUDP 2021 Curriculum Vitae Susie Lew
… Training: July 1979 - June1982 July 1982 - June 1985 B.S. Chemistry, Brooklyn College Brooklyn, New York M.D., … American Journal of Kidney Diseases, Published by W.B. Saunders Company 1996: American Society of Nephrology, … Int J Artif Organs 2008; 31(5):382-385. 41. Lew, SQ. Amphotericin B removal by plasma exchange. J Clin Pharm Ther …
021227_Caspofungin_Statistical_BPCA.pdf
… was a controlled study of caspofungin versus liposomal amphotericin B (AmBisome™) to assess the safety and efficacy of …
RX OPOE List December 2023
… via the 505(j) pathway may not be appropriate; section 505(b)(2) of the FD&C Act may be an appropriate abbreviated … SODIUM GLYCEROPHOSPHATE; SOYBEAN OIL N200656 EMULSION AMPHOTERICIN B N050724 INJECTABLE, LIPID COMPLEX ATAZANAVIR SULFATE …
Final RX OPOE List for posting June 2023 PDF
… via the 505(j) pathway may not be appropriate; section 505(b)(2) of the FD&C Act may be an appropriate abbreviated … SODIUM GLYCEROPHOSPHATE; SOYBEAN OIL N200656 EMULSION AMPHOTERICIN B N050724 INJECTABLE, LIPID COMPLEX ATAZANAVIR SULFATE …
21506 Micafungin Statistical BPCA
… pediatric patients received a dose increase. 2 mg/kg or (b) (4) Reference ID: 3266531 3 100 mg for patients weighing > … Candidiasis: Prophylaxis of Candida infections: (b) (4) (b) (4) (b) (4) • • • Supportive efficacy information … the efficacy and safety of micafungin vs. liposomal amphotericin B in adults and pediatric patients with …
ODP 2020 Curriculum Vitae Stephen McLeod
… EDUCATION 1982 - 1985 Dartmouth College, Hanover, N.H. A.B. Magna Cum Laude 1985 - 1989 Johns Hopkins University … and External Disease. Duane's Clinical Ophthalmology, J.B. Lippincott Company, Philadelphia, 2000 Section Editor 2001 … DA, Chidambaraum JD, McLeod SD, Acharya NR, Lietman TM. Amphotericin B and natamycin are not synergistic in vitro …
Detection of Galactomannan in Broncho-Alveolar Lavage Fluids
… treated with triazoles (ravuconazole) and polyenes (amphotericin B) compared to untreated rabbits (sensitivity 100%), while … t IP A Estimated Prevalencea BAL GM ≥ 0.5 BAL GM ≥ 1.0 Sn b Sp PPV NPV Sn b Sp PPV NPV Shahid et al., 2008 India …
21506 Micafungin Clinpharm BPCA
… 3. APPENDIX-B: PHARMACOMETRIC … contains data in neonates and young infants < 4 months of (b) (4)age. Astellas is not seeking an indication for this age … Efficacy and Safety of Micafungin (FK463) versus Liposomal Amphotericin B (AmBisome®) in the Treatment of Invasive …