Bacterial Skin and Skin Structure Infections

• FDA approval · 2018-10-02
  FDA Approved: NUZYRA — Original Application (Paratek Pharmaceuticals, Inc.)

  FDA approved NUZYRA (omadacycline) from Paratek Pharmaceuticals as an original application. The approval covers acute bacterial skin and ski…

• FDA approval · 2018-10-02
  FDA Approved: NUZYRA — Original Application (Paratek Pharmaceuticals, Inc.)

  The FDA granted original approval for Nuzyra (omadacycline) by Paratek Pharmaceuticals for two indications: acute bacterial skin and skin st…

• FDA approval · 2018-07-24
  FDA Approved: DALVANCE — Supplemental Application (Allergan, Inc.)

  FDA approved a supplemental application for dalbavancin (DALVANCE) from Allergan, resulting in updated labeling for its approved indications…

• FDA approval · 2018-03-20
  FDA Approved: ORBACTIV — Supplemental Application (Melinta Therapeutics, LLC)

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

• FDA approval · 2017-06-19
  FDA Approved: BAXDELA — Original Application (Melinta Therapeutics, LLC)

  FDA approved Baxdela (delafloxacin meglumine) from Melinta Therapeutics. The approval covers the original New Drug Application NDA208610 for…

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• FDA approval · 2017-06-19
  FDA Approved: BAXDELA — Original Application (Melinta Therapeutics, LLC)

  The FDA approves Baxdela (delafloxacin meglumine) for the treatment of acute bacterial skin and skin structure infections, with an additiona…

• FDA approval · 2016-10-17
  FDA Approved: ORBACTIV — Supplemental Application (Melinta Therapeutics, LLC)

  The FDA approved a supplemental application for ORBACTIV (oritavancin) from Melinta Therapeutics, LLC.

• FDA approval · 2016-09-16
  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 · 2016-01-20
  FDA Approved: ORBACTIV — Supplemental Application (Melinta Therapeutics, LLC)

  The FDA approved a supplemental application for ORBACTIV (oritavancin) submitted by Melinta Therapeutics, LLC. The action concerns the appro…

• FDA approval · 2015-12-18
  FDA Approved: DALVANCE — Supplemental Application (Allergan, Inc.)

  FDA approved a supplemental application for DALVANCE (dalbavancin) from Allergan, Inc.

• 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…

• 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…

• 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…

• 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.

• 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…