Babesiosis

• FDA approval · 2024-04-02
  FDA Approved: ATOVAQUONE — Supplemental Application (Camber Pharmaceuticals, Inc.)

  The FDA approved Camber Pharmaceuticals' supplemental application for atovaquone.

• FDA approval · 2022-11-22
  FDA Approved: ATOVAQUONE ORAL SUSPENSION — Supplemental Application (KVK-Tech, Inc.)

  FDA approved a supplemental application to authorize the Atovaquone oral suspension produced by KVK-Tech, Inc.

• FDA approval · 2021-10-25
  FDA Approved: ATOVAQUONE — Original Application (PAI Holdings, LLC dba PAI Pharma)

  FDA approved the original application for atovaquone, including the oral suspension, from PAI Holdings, LLC dba PAI Pharma, marking approval…

• FDA approval · 2021-03-30
  FDA Approved: ATOVAQUONE — Original Application (Bionpharma Inc.)

  FDA approved the original ANDA for atovaquone by Bionpharma Inc., authorizing a generic version of the medication.

• FDA approval · 2019-11-07
  FDA Approved: ATOVAQUONE — Supplemental Application (Chartwell Governmental & Specialty RX, LLC.)

  FDA approved a supplemental application for atovaquone submitted by Chartwell Governmental & Specialty RX, LLC.

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• FDA approval · 2019-05-31
  FDA Approved: ATOVAQUONE ORAL SUSPENSION — Original Application (KVK-Tech, Inc.)

  FDA approved a generic version of atovaquone oral suspension (KVK-Tech, Inc.) via Original Application (ANDA210510).

• FDA approval · 2019-02-22
  FDA Approved: MEPRON — Supplemental Application (GlaxoSmithKline LLC)

  FDA approved a supplemental application for Mepron (atovaquone) submitted by GlaxoSmithKline LLC. The action updates the drug's labeling/ind…

• FDA approval · 2018-11-21
  FDA Approved: ATOVAQUONE — Original Application (Glenmark Pharmaceuticals Inc., USA)

  FDA approved the original application for atovaquone as a generic drug, confirming its approved uses for Pneumocystis jirovecii pneumonia, p…

• FDA approval · 2018-10-11
  FDA Approved: ATOVAQUONE — Original Application (Camber Pharmaceuticals, Inc.)

  FDA approves Camber Pharmaceuticals' generic atovaquone under an original ANDA (ANDA 210692).

• FDA approval · 2015-06-04
  FDA Approved: MEPRON — Supplemental Application (GlaxoSmithKline LLC)

  FDA approved a supplemental application for Mepron (atovaquone) from GlaxoSmithKline LLC.

• FDA approval · 2014-03-18
  FDA Approved: ATOVAQUONE — Original Application (Amneal Pharmaceuticals LLC)

  FDA approves Amneal Pharmaceuticals LLC's original ANDA for ATOVAQUONE, providing a generic option for Pneumocystis jirovecii pneumonia prop…

• FDA approval · 2013-03-01
  FDA Approved: MEPRON — Supplemental Application (GlaxoSmithKline LLC)

  FDA approved a supplemental application for MEPRON (atovaquone) from GlaxoSmithKline LLC.