Complicated Skin and Skin Structure Infections

• FDA approval · 2025-04-30
  FDA Approved: DAPTOMYCIN IN SODIUM CHLORIDE — Supplemental Application (Baxter Healthcare Corporation)

  FDA approves Baxter's supplemental application for daptomycin in sodium chloride, adding a saline formulation of the antibiotic.

• FDA approval · 2025-04-30
  FDA Approved: DAPTOMYCIN — Supplemental Application (Civica, Inc.)

  FDA approved a supplemental application for daptomycin submitted by Civica, Inc.

• FDA approval · 2024-08-29
  FDA Approved: DAPTOMYCIN — Original Application (Biocon Pharma Inc.)

  FDA approved Biocon Pharma Inc.'s original application for daptomycin (DAPTOMYCIN), a generic antibiotic.

• FDA approval · 2024-06-13
  FDA Approved: ERTAPENEM — Supplemental Application (Eugia US LLC)

  FDA approved a supplemental application for Ertapenem (ERTAPENEM) by Eugia US LLC. The action relates to a modification/expansion of the dru…

• FDA approval · 2023-09-19
  FDA Approved: DAPTOMYCIN — Supplemental Application (Sagent Pharmaceuticals)

  The FDA approved a supplemental application for daptomycin filed by Sagent Pharmaceuticals (ANDA 207104), resulting in an approved regulator…

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• FDA approval · 2023-08-07
  FDA Approved: DAPTOMYCIN — Original Application (Mylan Institutional LLC)

  FDA approves a generic version of daptomycin under an Original Application (ANDA) from Mylan Institutional LLC.

• FDA label_change · 2023-05-16
  FDA Approved: DAPTOMYCIN — Supplemental Application (Fresenius Kabi USA, LLC)

  FDA approved a supplemental application for daptomycin by Fresenius Kabi USA, LLC. The action typically results in labeling changes or new/c…

• FDA approval · 2023-02-27
  FDA Approved: DAPTOMYCIN IN SODIUM CHLORIDE — Supplemental Application (Baxter Healthcare Corporation)

  FDA approved a supplemental application for Daptomycin in Sodium Chloride from Baxter, authorizing a saline formulation of the antibiotic.

• FDA approval · 2022-12-23
  FDA Approved: DAPTOMYCIN — Original Application (NorthStar RxLLC)

  FDA approves NorthStar RxLLC's generic daptomycin (DAPTOMYCIN) under an Original ANDA. The approval confirms the generic's indication for us…

• FDA approval · 2022-11-13
  FDA Approved: DAPTOMYCIN — Supplemental Application (APOTEX CORP.)

  FDA approved a supplemental application for Daptomycin from Apotex Corp. (ANDA 215316).

• FDA approval · 2022-09-23
  FDA Approved: DAPTOMYCIN — Original Application (NorthStar RxLLC)

  The FDA approved the original application for daptomycin (generic) submitted by NorthStar RxLLC.

• FDA approval · 2022-08-18
  FDA Approved: DAPTOMYCIN — Original Application (Sintetica US LLC)

  The FDA approved the original application for daptomycin from Sintetica US LLC.

• FDA label_change · 2022-02-07
  FDA Approved: DAPTOMYCIN — Supplemental Application (Sagent Pharmaceuticals)

  FDA approved a supplemental application for daptomycin, resulting in labeling updates.

• FDA approval · 2022-01-25
  FDA Approved: DAPTOMYCIN IN SODIUM CHLORIDE — Original Application (Baxter Healthcare Corporation)

  FDA approved Daptomycin in Sodium Chloride from Baxter Healthcare Corporation through an Original Application. The approval establishes a sa…

• FDA approval · 2021-09-02
  FDA Approved: DAPTOMYCIN — Original Application (Eugia US LLC)

  FDA approved the original application for daptomycin for Eugia US LLC, authorizing clearance of a generic daptomycin product.

• FDA approval · 2021-08-24
  FDA Approved: DAPTOMYCIN — Original Application (APOTEX CORP.)

  FDA approved Apotex's Original Application for a generic version of daptomycin. The product is indicated for complicated skin and skin struc…

• FDA approval · 2021-06-29
  FDA Approved: DAPTOMYCIN — Original Application (Meitheal Pharmaceuticals Inc.)

  The FDA approved Meitheal Pharmaceuticals' generic daptomycin (daptomycin) under an original ANDA (ANDA 213623), authorizing its marketing a…

• FDA approval · 2021-06-21
  FDA Approved: DAPTOMYCIN — Original Application (Hospira, Inc.)

  FDA approved daptomycin (Hospira) under the original application NDA210282, establishing its use for complicated skin and skin structure inf…

• FDA approval · 2021-05-05
  FDA Approved: DAPTOMYCIN — Supplemental Application (Civica, Inc.)

  The FDA approved a supplemental application for Civica, Inc.'s daptomycin. This action approves an update requested in the supplemental subm…

• FDA approval · 2021-04-21
  FDA Approved: DAPTOMYCIN — Original Application (Hisun Pharmaceuticals USA, Inc.)

  FDA approved the original application for daptomycin (generic) by Hisun Pharmaceuticals USA, Inc. for the approved indications of complicate…

• FDA approval · 2020-08-31
  FDA Approved: DAPTOMYCIN — Original Application (Dr. Reddy's Laboratories Inc.,)

  FDA approved the original application for daptomycin by Dr. Reddy's Laboratories Inc., marking the first generic approval for the drug. The …

• FDA approval · 2020-08-20
  FDA Approved: DAPTOMYCIN — Original Application (BE Pharmaceuticals Inc.)

  The FDA approved BE Pharmaceuticals Inc.'s Original Application for Daptomycin (DAPTOMYCIN) as a generic antibiotic. The approval enables ge…

• FDA approval · 2020-04-09
  FDA Approved: TIGECYCLINE — Supplemental Application (Sandoz Inc)

  FDA approved Sandoz Inc's supplemental application for tigecycline, a generic antibiotic. This action concerns the ANDA for tigecycline (AND…

• FDA label_change · 2020-04-03
  FDA Approved: DAPTOMYCIN — Supplemental Application (Sagent Pharmaceuticals)

  FDA notice of a supplemental application for Daptomycin submitted by Sagent Pharmaceuticals, with the submission status shown as AP.

• FDA approval · 2020-02-20
  FDA Approved: VIBATIV — Supplemental Application (Cumberland Pharmaceuticals Inc.)

  FDA approved a supplemental application for VIBATIV (telavancin hydrochloride) from Cumberland Pharmaceuticals Inc. The approval indicates t…