Biliary Tract Disease

• FDA approval · 2023-10-17
  FDA Approved: KINEVAC — Supplemental Application (Bracco Diagnostics Inc.)

  The FDA approved Bracco Diagnostics' supplemental application for KINEVAC (sincalide), updating its labeling for use in hepatobiliary imagin…

• FDA approval · 2022-11-22
  FDA Approved: SINCALIDE — Original Application (MAIA Pharmaceuticals, Inc.)

  FDA approved an Original Application for Sincalide (sincalide) by MAIA Pharmaceuticals, Inc., authorizing its use as a diagnostic agent for …

• FDA approval · 2018-02-09
  FDA Approved: KINEVAC — Supplemental Application (Bracco Diagnostics Inc.)

  The FDA approved a supplemental application for KINEVAC (Sincalide) from Bracco Diagnostics, updating labeling to support its diagnostic use…

• FDA approval · 2016-02-17
  FDA Approved: KINEVAC — Supplemental Application (Bracco Diagnostics Inc.)

  FDA approved a supplemental application for KINEVAC (sincalide) submitted by Bracco Diagnostics Inc.

• FDA approval · 2015-09-10
  FDA Approved: CHOLETEC — Supplemental Application (Bracco Diagnostics Inc)

  FDA approved a supplemental application for CHOLETEC (mebrofenin) submitted by Bracco Diagnostics Inc. This entry notes the supplemental app…

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• FDA approval · 2015-08-18
  FDA Approved: KINEVAC — Supplemental Application (Bracco Diagnostics Inc.)

  FDA approved a supplemental application for KINEVAC (sincalide) submitted by Bracco Diagnostics Inc., indicating approval of changes under a…

• FDA approval · 2014-07-18
  FDA Approved: KINEVAC — Supplemental Application (Bracco Diagnostics Inc.)

  FDA approved a supplemental application for KINEVAC (sincalide) from Bracco Diagnostics Inc., representing a supplemental approval related t…

• FDA approval · 2010-08-12
  FDA Approved: KIT FOR THE PREPARATION OF TECHNETIUM TC 99M MEBROFENIN — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  FDA approves a supplemental application for a kit to prepare Technetium-99m mebrofenin for hepatobiliary imaging, manufactured by Sun Pharma…