Bacterial Skin and Skin Structure Infections

• FDA approval · 2026-02-27
  FDA Approved: SIVEXTRO — Supplemental Application (Merck Sharp & Dohme LLC)

  The FDA approved a supplemental application for Sivextro (tedizolid phosphate) filed by Merck Sharp & Dohme LLC, resulting in updated labeli…

• FDA approval · 2026-02-26
  FDA Approved: DALBAVANCIN — Original Application (Long Grove Pharmaceuticals, LLC)

  The FDA approved a generic dalbavancin hydrochloride product from Long Grove Pharmaceuticals, LLC. It is indicated for acute bacterial skin …

• FDA approval · 2025-11-26
  FDA Approved: DALBAVANCIN — Original Application (Meitheal Pharmaceuticals Inc)

  FDA approves Meitheal Pharmaceuticals' generic dalbavancin for the treatment of acute bacterial skin and skin structure infections.

• EMA approval · 2025-11-20
  EMA Authorised: Xydalba (dalbavancin hydrochloride) — AbbVie Deutschland GmbH & Co. KG

  The EMA authorised Xydalba (dalbavancin hydrochloride) for soft tissue infections, including acute bacterial skin and skin structure infecti…

• FDA approval · 2025-11-10
  FDA Approved: DALBAVANCIN HYDROCHLORIDE — Original Application (Fresenius Kabi USA, LLC)

  FDA approved the original application for dalbavancin hydrochloride (Fresenius Kabi USA, LLC), authorizing its generic formulation for use i…

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• FDA approval · 2025-10-23
  FDA Approved: DALBAVANCIN — Original Application (Teva Pharmaceuticals, Inc.)

  FDA approved Teva's original ANDA for dalbavancin, allowing generic production of the antibiotic.

• FDA approval · 2024-08-22
  FDA Approved: LINEZOLID — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  The FDA approved Hikma Pharmaceuticals USA Inc.'s supplemental application for LINEZOLID (linezolid); the approval finalizes changes to the …

• FDA approval · 2023-12-01
  FDA Approved: BAXDELA — Supplemental Application (Melinta Therapeutics, LLC)

  The FDA approved a supplemental application for Baxdela (delafloxacin meglumine) submitted by Melinta Therapeutics, LLC. The update changes …

• FDA approval · 2023-11-21
  FDA Approved: LINEZOLID — Supplemental Application (Camber Pharmaceuticals, Inc.)

  FDA approved Camber Pharmaceuticals' supplemental application for Linezolid (generic linezolid) under ANDA 211813. This action confirms appr…

• FDA approval · 2022-10-31
  FDA Approved: LINEZOLID — Original Application (Camber Pharmaceuticals, Inc.)

  FDA approved Camber Pharmaceuticals' LINEZOLID generic under an Original Abbreviated New Drug Application (ANDA 211813). The approval covers…

• FDA approval · 2022-02-17
  FDA Approved: LINEZOLID — Supplemental Application (Hospira, Inc.)

  FDA approved a supplemental application for Linezolid submitted by Hospira, Inc. under NDA206473.

• FDA approval · 2021-11-17
  FDA Approved: SIVEXTRO — Supplemental Application (Merck Sharp & Dohme LLC)

  FDA approved a supplemental application for Sivextro (tedizolid phosphate) from Merck Sharp & Dohme LLC. This action updates the product’s l…

• FDA approval · 2021-10-26
  FDA Approved: ZYVOX — Supplemental Application (Pharmacia & Upjohn Company LLC)

  The FDA approved a supplemental application for Zyvox (linezolid) from Pharmacia & Upjohn Company LLC.

• FDA approval · 2021-09-21
  FDA Approved: CEFTAROLINE FOSAMIL — Original Application (Apotex Corp.)

  The FDA approved Apotex Corp.'s original application for ceftaroline fosamil, making a generic ceftaroline fosamil available in the United S…

• FDA approval · 2021-07-22
  FDA Approved: DALVANCE — Supplemental Application (Allergan, Inc.)

  FDA approved Allergan's supplemental application for DALVANCE (dalbavancin), resulting in changes to the drug's labeling.

• FDA approval · 2021-03-12
  FDA Approved: KIMYRSA — Original Application (Melinta Therapeutics, LLC)

  FDA approved KIMYRSA (oritavancin diphosphate) from Melinta Therapeutics, LLC for the treatment of acute bacterial skin and skin structure i…

• FDA approval · 2020-10-22
  FDA Approved: SIVEXTRO — Supplemental Application (Merck Sharp & Dohme LLC)

  FDA approved a supplemental application for Sivextro (tedizolid phosphate) submitted by Merck Sharp & Dohme LLC. This action results in chan…

• FDA approval · 2020-10-20
  FDA Approved: NUZYRA — Supplemental Application (Paratek Pharmaceuticals, Inc.)

  FDA's supplemental application for NUZYRA (omadacycline) submitted by Paratek Pharmaceuticals, Inc., with the submission status indicated as…

• FDA approval · 2020-09-02
  FDA Approved: NUZYRA — Supplemental Application (Paratek Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for NUZYRA (omadacycline) filed by Paratek Pharmaceuticals, Inc.

• FDA approval · 2020-06-19
  FDA Approved: SIVEXTRO — Supplemental Application (Merck Sharp & Dohme LLC)

  The FDA approved a supplemental application for SIVEXTRO (tedizolid phosphate) submitted by Merck Sharp & Dohme LLC.

• FDA approval · 2019-12-11
  FDA Approved: ORBACTIV — Supplemental Application (Melinta Therapeutics, LLC)

  FDA approved a supplemental application for ORBACTIV (oritavancin) filed by Melinta Therapeutics, LLC.

• FDA approval · 2019-10-24
  FDA Approved: BAXDELA — Supplemental Application (Melinta Therapeutics, LLC)

  The FDA approved a supplemental application for Baxdela (delafloxacin meglumine) submitted by Melinta Therapeutics.

• FDA approval · 2019-09-09
  FDA Approved: SIVEXTRO — Supplemental Application (Merck Sharp & Dohme LLC)

  FDA approved a supplemental application for Sivextro (tedizolid phosphate) from Merck Sharp & Dohme LLC.

• FDA approval · 2019-06-13
  FDA Approved: NUZYRA — Supplemental Application (Paratek Pharmaceuticals, Inc.)

  FDA approves a supplemental application for NUZYRA (omadacycline) submitted by Paratek Pharmaceuticals, Inc. The approval pertains to a supp…

• FDA approval · 2018-10-18
  FDA Approved: BAXDELA — Supplemental Application (Melinta Therapeutics, LLC)

  FDA approves a supplemental application for Baxdela (delafloxacin meglumine) submitted by Melinta Therapeutics, LLC.