Search
Session 2 Neil Ampel
… • newer antifungals - can therapy be stopped? - role of IT amphotericin B - role of IV liposomal amphotericin B • Management of patients on biologics and with …
FY 2020 Awarded GDUFA Science and Research Contracts and Grants
… of Critical Process Parameters for the Preparation of Amphotericin B that Influence Toxicity • Awarded to Landrau Scientific … conditions impact the critical quality attributes (CQA) of amphotericin B liposomes. The work will focus on developing …
Session-2-Kieran-Marr
… in Healthcare Implementation Antifungal Agents: Timeline Amphotericin B Flucytosine Ketoconazole Fluconazole Itraconazole Lipid-based Amphotericin B Caspofungin Voriconazole Micafungin …
021227_Caspofungin_Clinpharm_BPCA.pdf
… refractory to or intolerant of other fungal agents (i.e., amphotericin B, lipid formulations of amphotericin B, and/or itraconazole); (2) invasive …
MDP-2022-Curriculum-Vitae-Barbara-Alexander
… 1981-1983 College Transfer UNC at Wilmington 1983-1985 B.A., Biology Graduate/Professional School: Duke University … 23. Alexander BD and Wingard JR. Study of renal safety in amphotericin B lipid complex (ABLC)–treated patients: … Non- comparative evaluation of the safety of aerosolized amphotericin B lipid complex in patients undergoing …
FY 2016 Awarded GDUFA Regulatory Research Contracts and Grants
… Critical process parameters for the preparation of Amphotericin B liposomes • Awarded to Neo-Advent Technologies LLC … how the critical physicochemical attributes of liposomal amphotericin B can be affected by differences in these …
N021506_micafungin_Amend_4
… micafungin sodium vs. an appropriate comparator (e.g. amphotericin B deoxycholate) for treatment of serious Candida infections … in comparison to an appropriate comparator (e.g. amphotericin B deoxycholate) for treatment of serious Candida …
Final RX OPOE List for posting December 2022 PDF
… via the 505(j) pathway may not be appropriate; section 505(b)(2) of the FD&C Act may be an appropriate abbreviated … N200656 EMULSION AMPHOTERICIN B N050724 INJECTABLE, LIPID COMPLEX ATAZANAVIR SULFATE …
D1S06-Kozak
… for Generic Products Containing Nanomaterials • Section VI.B of FDA’s guidance for industry, Drug Products, Including … 09/10/2020 10/12/2021 050740 AmBisome 08/11/1997 Amphotericin B liposomal injection 212514 12/14/2021 022212 … has steadily increased. In 2021-2022 the first generic amphotericin B liposomal injection, difluprednate ophthalmic …
Patient Information - Epicel (cultured epidermal autografts)
… include: antibiotics such as vancomycin, amikacin or amphotericin B; bovine (cow) serum; hormones such as insulin, … Severe allergy to antibiotics, vancomycin, amikacin or amphotericin because Epicel is grown in media containing …
Directions for Use - Epicel (cultured epidermal autografts)
… following exposure to vancomycin, amikacin, or amphotericin, as trace quantities of these anti-infective … anti-infective agents such as vancomycin, amikacin or amphotericin B; bovine serum; culture media supplements such as 11 …
Package Insert - RabAvert
… based on ELISA. Antibiotics (neomycin, chlortetracycline, amphotericin B) added during cell and virus propagation are largely … is present at ≤10 mcg, chlortetracycline at ≤200 ng, and amphotericin B at ≤20 ng per dose. RabAvert is intended for …
LAVIV® (azficel-T) Package Insert and Patient Information Sheet
… Allogeneic use of LAVIV Allergy to gentamicin, amphotericin, dimethyl sulfoxide (DMSO), or material of … Do not use LAVIV in patients allergic to gentamicin, amphotericin, dimethyl sulfoxide (DMSO), or material of …
FDA Office of Generic Drugs Office of Research & Standards (ORS) Posters Presented by External Collaborators and ORS Staff in Fiscal Year 2015
… 2015. 11. Bodenlenz M, Tiffner K, Raml R, Tschapeller B, Augustin T, Dragatin C, Birngruber T, Kainz S, Schwagerle … M, Szoka FC, Schwendeman A. Development Of The Liposomal Amphotericin B Release, AAPS 2015, Orlando, FL, October … M, Szoka FC, Schwendeman A. Development Of The Liposomal Amphotericin B Release Assay, NIPTE 2015 Conference, …
N021506_micafungin_Amend_2
… micafungin sodium vs. an appropriate comparator (e.g. amphotericin B deoxycholate) for treatment of serious Candida infections … in comparison to an appropriate comparator (e.g. amphotericin B deoxycholate) for treatment of serious Candida …
N021506_micafungin_Amend_3
… micafungin sodium vs. an appropriate comparator (e.g. amphotericin B deoxycholate) for treatment of serious Candida infections … in comparison to an appropriate comparator (e.g. amphotericin B deoxycholate) for treatment of serious Candida …
N021506_micafungin_Amend_1
… micafungin sodium vs. an appropriate comparator (e.g. amphotericin B deoxycholate) for treatment of serious Candida infections … in comparison to an appropriate comparator (e.g. amphotericin B deoxycholate) for treatment of serious Candida …
N021506_micafungin_Orig_WR
… micafungin sodium vs. an appropriate comparator (e.g. amphotericin B deoxycholate) for treatment of serious Candida infections … in comparison to an appropriate comparator (e.g. amphotericin B deoxycholate) for treatment of serious Candida …
122019 List of Off Patent Off Exclusivity Drugs with no approved generic XLS
… 050824 CAPSULE, TABLET, CAPSULE, DELAYED RELEASE AMPHOTERICIN B 050740 INJECTABLE, LIPOSOMAL APOMORPHINE HYDROCHLORIDE … EMULSION AMINOLEVULINIC ACID HYDROCHLORIDE 208081 GEL AMPHOTERICIN B 050724 INJECTABLE, LIPID COMPLEX ATAZANAVIR …
2020-06 List of Off-Patent, Off-Exclusivity Drugs without an Approved Generic XLS
… N050824 CAPSULE, TABLET, CAPSULE, DELAYED RELEASE AMPHOTERICIN B N050740 INJECTABLE, LIPOSOMAL APOMORPHINE HYDROCHLORIDE … EMULSION AMINOLEVULINIC ACID HYDROCHLORIDE N208081 GEL AMPHOTERICIN B N050724 INJECTABLE, LIPID COMPLEX ATAZANAVIR …
OPOE_Update_6_2021_xlsx
… N050824 CAPSULE, TABLET, CAPSULE, DELAYED RELEASE AMPHOTERICIN B N050740 INJECTABLE, LIPOSOMAL APOMORPHINE HYDROCHLORIDE … EMULSION AMINOLEVULINIC ACID HYDROCHLORIDE N208081 GEL AMPHOTERICIN B N050724 INJECTABLE, LIPID COMPLEX ATAZANAVIR …
Excel Version_December 2020 List of Off-Patent, Off-Exclusivity Drugs without an Approved Generic
… N050824 CAPSULE, TABLET, CAPSULE, DELAYED RELEASE AMPHOTERICIN B N050740 INJECTABLE, LIPOSOMAL APOMORPHINE HYDROCHLORIDE … EMULSION AMINOLEVULINIC ACID HYDROCHLORIDE N208081 GEL AMPHOTERICIN B N050724 INJECTABLE, LIPID COMPLEX ATAZANAVIR …
RX opoe update for posting 2021_12
… CHLORIDE N016822 INJECTABLE AMISULPRIDE N209510 SOLUTION AMPHOTERICIN B N050740 INJECTABLE, LIPOSOMAL APOMORPHINE HYDROCHLORIDE … EMULSION AMINOLEVULINIC ACID HYDROCHLORIDE N208081 GEL AMPHOTERICIN B N050724 INJECTABLE, LIPID COMPLEX ATAZANAVIR …
Journal Articles Published Relating to GDUFA Research in Fiscal Year 2019
… DOI 10.1002/psp4.12424 PMID: 31087531. 6. Bao, Q., Gu, B., Price, C., Zou, Y., Wang, Y., Kozak, D., Choi, S., and … of Size-Based Distribution of Drug and Excipient in Amphotericin B Liposomal Formulation. International Journal … Parameters in Manufacturing of Liposomal Formulations of Amphotericin B. International Journal of Pharmaceutics. …
Package Insert - Biotestcell A1 & B and Biotestcell A2
… Germany Reagent Red Blood Cells Biotestcell® A1 & B Biotestcell® A2 3.0 to 3.4% Pooled cells for Reverse … 0.01% Neomycin, 0.033% Chloramphenicol, 5 ppm Amphotericin B PRECAUTIONS • For In-vitro diagnostic use. • … 0.01% Neomycin, 0.033% Chloramphenicol, 5 ppm Amphotericin B PRECAUTIONS · For In-vitro diagnostic use. · …