Community-acquired Bacterial Pneumonia

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

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

• 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 · 2020-04-09
  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 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.

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• 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 · 2019-06-11
  FDA Approved: TIGECYCLINE — Original Application (Eugia US LLC)

  FDA approved the original application for a generic tigecycline product by Eugia US LLC, enabling market availability of a generic tigecycli…

• 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.

• 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 · 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 · 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 · 2011-06-29
  FDA Approved: TEFLARO — Supplemental Application (Allergan, Inc.)

  The FDA approved a supplemental application for TEFLARO (ceftaroline fosamil) submitted by Allergan, Inc., under NDA 200327.

• 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…