Complicated Skin and Skin Structure Infections

• FDA approval · 2019-08-22
  FDA Approved: DAPTOMYCIN — Original Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved Hikma Pharmaceuticals USA Inc.'s generic daptomycin under an Original Application. The approval covers the same indications as …

• FDA approval · 2019-07-12
  FDA Approved: DAPTOMYCIN — Original Application (Accord Healthcare, Inc.)

  FDA approved Accord Healthcare, Inc.'s original application for daptomycin (generic), authorizing a generic version of the antibiotic.

• FDA approval · 2019-06-26
  FDA Approved: DAPTOMYCIN — Original Application (BE Pharmaceuticals Inc.)

  FDA approved BE Pharmaceuticals Inc.'s original application for daptomycin, enabling the generic version of this antibiotic.

• FDA approval · 2019-06-24
  FDA Approved: DAPTOMYCIN — Original Application (Accord Healthcare Inc.)

  FDA approves the original application for Daptomycin (generic) from Accord Healthcare Inc., authorizing its commercialization as a generic a…

• 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…

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• FDA approval · 2018-12-21
  FDA Approved: TIGECYCLINE — Original Application (Apotex Corp)

  FDA approves Apotex Corp's original application for tigecycline, granting approval of a generic version of the antibiotic.

• FDA approval · 2018-06-05
  FDA Approved: DAPTOMYCIN — Original Application (Mylan Institutional LLC)

  FDA approved a generic daptomycin product from Mylan Institutional LLC via an Original Application. This approval provides a non-brand versi…

• FDA approval · 2018-04-11
  FDA Approved: DAPTOMYCIN — Original Application (Fresenius Kabi USA, LLC)

  FDA listing shows Fresenius Kabi USA, LLC's original application approval for daptomycin, establishing its approval for complicated skin and…

• FDA approval · 2017-09-12
  FDA Approved: DAPTOMYCIN — Original Application (Sagent Pharmaceuticals)

  FDA approval record for Daptomycin under an Original Application by Sagent Pharmaceuticals (NDA 208385). The entry documents FDA approval of…

• FDA approval · 2016-07-26
  FDA Approved: MOXIFLOXACIN — Supplemental Application (Fresenius Kabi USA, LLC)

  FDA approved a supplemental application for moxifloxacin hydrochloride (MOXIFLOXACIN) from Fresenius Kabi USA, LLC, indicating a modificatio…

• FDA approval · 2016-06-15
  FDA Approved: DAPTOMYCIN — Original Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved the original application for daptomycin, a bacterial antibiotic, as a generic version manufactured by Hikma Pharmaceuticals USA…

• FDA approval · 2014-03-13
  FDA Approved: VIBATIV — Supplemental Application (Cumberland Pharmaceuticals Inc.)

  FDA approved a supplemental labeling application for VIBATIV (telavancin hydrochloride) submitted by Cumberland Pharmaceuticals. The approva…

• FDA approval · 2013-12-12
  FDA Approved: VIBATIV — Supplemental Application (Cumberland Pharmaceuticals Inc.)

  FDA approved a supplemental application for Vibativ (telavancin hydrochloride) from Cumberland Pharmaceuticals Inc.

• FDA approval · 2013-02-01
  FDA Approved: VIBATIV — Supplemental Application (Cumberland Pharmaceuticals Inc.)

  FDA approved a supplemental application for VIBATIV (telavancin hydrochloride) from Cumberland Pharmaceuticals, updating the labeling under …

• 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 · 2009-09-11
  FDA Approved: VIBATIV — Original Application (Cumberland Pharmaceuticals Inc.)

  FDA approved Vibativ (telavancin hydrochloride) through an original NDA for the treatment of hospital-acquired bacterial pneumonia and compl…

• FDA approval · 2007-04-26
  FDA Approved: LINEZOLID — Supplemental Application (Mylan Pharmaceuticals Inc.)

  The FDA approved a supplemental application for LINEZOLID submitted by Mylan Pharmaceuticals Inc., associated with updates to the product’s …

• FDA approval · 2007-04-03
  FDA Approved: TYGACIL — Supplemental Application (Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.)

  The FDA approved a supplemental application for TYGACIL (tigecycline) by Wyeth Pharmaceuticals (a Pfizer subsidiary), indicating regulatory …