Bacterial Skin and Skin Structure Infections
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Sign up freeTop drugs studied for this disease
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FDA approval · 2026-02-27FDA 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…
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FDA approval · 2026-02-26FDA 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 …
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FDA approval · 2025-11-26FDA Approved: DALBAVANCIN — Original Application (Meitheal Pharmaceuticals Inc)
FDA approves Meitheal Pharmaceuticals' generic dalbavancin for the treatment of acute bacterial skin and skin structure infections.
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EMA approval · 2025-11-20EMA 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…
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FDA approval · 2025-11-10FDA 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 · 2025-10-23FDA Approved: DALBAVANCIN — Original Application (Teva Pharmaceuticals, Inc.)
FDA approved Teva's original ANDA for dalbavancin, allowing generic production of the antibiotic.
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FDA approval · 2024-08-22FDA 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 …
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CLINICAL_TRIALS trial_result · 2024-07-03Clinical Trial Update: A Study of Safety and Efficacy of MK-1986 (Tedizolid Phosphate) and Comparator in Participants From Birth to Less Than 12 Years of Age With Acute Bacterial Skin and Skin Structure Infections (MK-1986-018) [Phase 3]
A Phase 3 pediatric trial evaluating Tedizolid Phosphate (MK-1986) versus a comparator for acute bacterial skin and skin structure infection…
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FDA approval · 2023-12-01FDA 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 …
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FDA approval · 2023-11-21FDA Approved: LINEZOLID — Supplemental Application (Camber Pharmaceuticals, Inc.)
FDA approved Camber Pharmaceuticals' supplemental application for Linezolid (generic linezolid) under ANDA 211813. This action confirms appr…
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CLINICAL_TRIALS trial_result · 2023-05-03Clinical Trial Update: Safety and Efficacy of Strategy to Prevent Drug-Induced Nephrotoxicity in High-Risk Patients [Phase 4]
Phase 4 clinical trial update on a strategy to prevent drug-induced nephrotoxicity in high-risk patients; the study was terminated with resu…
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CLINICAL_TRIALS trial_result · 2022-12-09Clinical Trial Update: Hospital Avoidance Strategies for ABSSSI [Phase 4]
Phase 4 clinical trial evaluating hospital avoidance strategies for acute bacterial skin and skin structure infections (ABSSSI) has been ter…
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FDA approval · 2022-10-31FDA 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…
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FDA approval · 2022-02-17FDA Approved: LINEZOLID — Supplemental Application (Hospira, Inc.)
FDA approved a supplemental application for Linezolid submitted by Hospira, Inc. under NDA206473.
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FDA approval · 2021-11-17FDA 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…
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FDA approval · 2021-10-26FDA Approved: ZYVOX — Supplemental Application (Pharmacia & Upjohn Company LLC)
The FDA approved a supplemental application for Zyvox (linezolid) from Pharmacia & Upjohn Company LLC.
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FDA approval · 2021-09-21FDA 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…
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FDA approval · 2021-07-22FDA Approved: DALVANCE — Supplemental Application (Allergan, Inc.)
FDA approved Allergan's supplemental application for DALVANCE (dalbavancin), resulting in changes to the drug's labeling.
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FDA approval · 2021-03-12FDA 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…
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FDA approval · 2020-10-22FDA 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…
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FDA approval · 2020-10-20FDA 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…
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FDA approval · 2020-09-02FDA Approved: NUZYRA — Supplemental Application (Paratek Pharmaceuticals, Inc.)
The FDA approved a supplemental application for NUZYRA (omadacycline) filed by Paratek Pharmaceuticals, Inc.
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CLINICAL_TRIALS trial_result · 2020-06-29Clinical Trial Update: Comparative Study of Levonadifloxacin (IV and Oral) With Linezolid (IV and Oral) in Acute Bacterial Skin and Skin Structure Infections (ABSSSI) [Phase 3]
Phase 3 trial comparing levonadifloxacin (IV and oral) to linezolid (IV and oral) for acute bacterial skin and skin structure infections has…
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FDA approval · 2020-06-19FDA Approved: SIVEXTRO — Supplemental Application (Merck Sharp & Dohme LLC)
The FDA approved a supplemental application for SIVEXTRO (tedizolid phosphate) submitted by Merck Sharp & Dohme LLC.
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CLINICAL_TRIALS trial_result · 2020-05-18Clinical Trial Update: Ceftobiprole in the Treatment of Patients With Acute Bacterial Skin and Skin Structure Infections [Phase 3]
Phase 3 clinical trial update for ceftobiprole in acute bacterial skin and skin structure infections has completed with posted results.