Bacterial Skin and Skin Structure Infections

• FDA label_change · 2015-08-31
  FDA Approved: TEFLARO — Supplemental Application (Allergan, Inc.)

  FDA entry documenting a supplemental application for TEFLARO (ceftaroline fosamil) submitted by Allergan, Inc. This reflects a labeling or i…

• FDA approval · 2014-11-20
  FDA Approved: DALVANCE — Supplemental Application (Allergan, Inc.)

  FDA approved a supplemental application for Dalvance (dalbavancin) submitted by Allergan, Inc. The action approves a supplemental NDA relate…

• CLINICAL_TRIALS trial_result · 2014-09-03
  Clinical Trial Update: TR-701 FA vs. Linezolid for the Treatment of Acute Bacterial Skin and Skin Structure Infections. [Phase 3]

  Phase 3 trial comparing TR-701 (tidarubicin? actually TR-701 is dalbavancin-like? Not sure) for acute bacterial skin and skin structure infe…

• FDA approval · 2014-08-06
  FDA Approved: ORBACTIV — Original Application (Melinta Therapeutics, LLC)

  FDA approved ORBACTIV (oritavancin) in its original NDA for the treatment of acute bacterial skin and skin structure infections.

• FDA approval · 2014-06-20
  FDA Approved: SIVEXTRO — Original Application (Merck Sharp & Dohme LLC)

  FDA approved Sivextro (tedizolid phosphate) from Merck as the original application for the treatment of acute bacterial skin and skin struct…

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• FDA approval · 2014-06-20
  FDA Approved: SIVEXTRO — Original Application (Merck Sharp & Dohme LLC)

  FDA's original approval of Sivextro (tedizolid phosphate) by Merck Sharp & Dohme LLC for acute bacterial skin and skin structure infections.

• FDA approval · 2014-05-23
  FDA Approved: DALVANCE — Original Application (Allergan, Inc.)

  FDA approved the original application for Dalvance (dalbavancin) by Allergan, Inc., for the treatment of acute bacterial skin and skin struc…

• CLINICAL_TRIALS trial_result · 2014-02-12
  Clinical Trial Update: Efficacy and Safety of Dalbavancin for the Treatment of Acute Bacterial Skin and Skin Structure Infections [Phase 3]

  Phase 3 trial results show dalbavancin was effective and safe for acute bacterial skin and skin structure infections; the study completed wi…

• CLINICAL_TRIALS trial_result · 2013-12-25
  Clinical Trial Update: Efficacy and Safety of Dalbavancin for the Treatment of Acute Bacterial Skin and Skin Structure Infections [Phase 3]

  Phase 3 trial results evaluate the efficacy and safety of dalbavancin for acute bacterial skin and skin structure infections, including absc…

• FDA approval · 2013-05-29
  FDA Approved: TEFLARO — Supplemental Application (Allergan, Inc.)

  The FDA approved a supplemental application for TEFLARO (ceftaroline fosamil) submitted by Allergan, Inc., updating its labeling.

• CLINICAL_TRIALS research · 2012-11-12
  Clinical Trial Update: Vancomycin Versus Ceftaroline in Patients With Infections Caused by MRSA That Are Susceptible to Ceftaroline

  This ClinicalTrials.gov study compares vancomycin with ceftaroline in patients with MRSA infections susceptible to ceftaroline; the trial st…

• CLINICAL_TRIALS trial_result · 2012-08-07
  Clinical Trial Update: A Study of Safety, Tolerability, and Efficacy of AFN-12520000 in the Treatment of Acute Bacterial Skin and Skin Structure Infections Due to Staphylococci [Phase 2]

  This Phase 2 trial tested AFN-12520000 for acute bacterial skin and skin structure infections due to Staphylococci and has completed, report…

• FDA approval · 2012-01-20
  FDA Approved: AMOXICILLIN AND CLAVULANATE POTASSIUM — Original Application (Aurobindo Pharma Limited)

  FDA approved a generic version of amoxicillin and clavulanate potassium from Aurobindo Pharma Limited under an Original Application (ANDA 09…

• FDA approval · 2011-03-11
  FDA Approved: TEFLARO — Supplemental Application (Allergan, Inc.)

  The FDA approved a supplemental application for TEFLARO (ceftaroline fosamil) submitted by Allergan, Inc. The action confirms regulatory app…

• FDA approval · 2010-10-29
  FDA Approved: TEFLARO — Original Application (Allergan, Inc.)

  FDA approved TEFLARO (ceftaroline fosamil) under an original NDA (NDA 200327) from Allergan for the treatment of acute bacterial skin and sk…

• CLINICAL_TRIALS trial_result · 2010-03-18
  Clinical Trial Update: Comparative Study of NXL103 Versus Linezolid in Adults With Acute Bacterial Skin and Skin Structure Infections (ABSSSI) [Phase 2]

  This clinical trial update reports the completion of a Phase 2 study comparing NXL103 to Linezolid for acute bacterial skin and skin structu…