Bacterial Conjunctivitis

• FDA approval · 2017-10-04
  FDA Approved: MOXIFLOXACIN — Original Application (Aurobindo Pharma Limited)

  FDA approved MOXIFLOXACIN ophthalmic solution from Aurobindo Pharma as an Original Application (ANDA), providing a generic option for bacter…

• FDA approval · 2017-04-12
  FDA Approved: MAXITROL — Supplemental Application (Novartis Pharmaceuticals Corporation)

  FDA approved a supplemental application for MAXITROL (neomycin sulfate, polymyxin B sulfate and dexamethasone) by Novartis Pharmaceuticals C…

• FDA approval · 2017-03-14
  FDA Approved: VIGAMOX — Supplemental Application (Harrow Eye, LLC)

  FDA approved a supplemental application for Vigamox (moxifloxacin hydrochloride) submitted by Harrow Eye, LLC.

• FDA approval · 2016-08-05
  FDA Approved: CILOXAN — Supplemental Application (Sandoz Inc)

  FDA approved a supplemental application for Ciloxan (ciprofloxacin hydrochloride) submitted by Sandoz Inc.

• FDA approval · 2015-11-10
  FDA Approved: BESIVANCE — Supplemental Application (Bausch & Lomb Americas Inc.)

  FDA approved a supplemental application for BESIVANCE (besifloxacin) by Bausch & Lomb Americas Inc.

• Want full summaries, importance scores, and drug timelines? Upgrade to Plus or Pro.
• FDA approval · 2015-05-28
  FDA Approved: MOXIFLOXACIN — Original Application (Lupin Pharmaceuticals, Inc.)

  FDA approved Lupin Pharmaceuticals' MOXIFLOXACIN as a generic moxifloxacin ophthalmic solution; the approval covers its use for bacterial co…

• FDA approval · 2014-04-30
  FDA Approved: BESIVANCE — Supplemental Application (Bausch & Lomb Americas Inc.)

  FDA approved a supplemental application for BESIVANCE (besifloxacin) from Bausch & Lomb Americas Inc.

• FDA approval · 2013-08-16
  FDA Approved: BESIVANCE — Supplemental Application (Bausch & Lomb Americas Inc.)

  FDA approved a supplemental application for BESIVANCE (besifloxacin) submitted by Bausch & Lomb Americas Inc.

• FDA approval · 2013-05-10
  FDA Approved: BESIVANCE — Supplemental Application (Bausch & Lomb Americas Inc.)

  FDA approves a supplemental application for BESIVANCE (besifloxacin) submitted by Bausch & Lomb Americas, updating the drug’s labeling throu…

• FDA approval · 2013-04-29
  FDA Approved: OFLOXACIN OPHTHALMIC — Original Application (Altaire Pharmaceuticals Inc.)

  FDA approved Altaire Pharmaceuticals' OFLOXACIN OPHTHALMIC (ofloxacin ophthalmic solution) through an Original Application (ANDA).

• FDA approval · 2013-03-12
  FDA Approved: AZASITE — Supplemental Application (Thea Pharma Inc.)

  The FDA approved a supplemental application for AZASITE (azithromycin monohydrate ophthalmic solution) submitted by Thea Pharma Inc.

• FDA approval · 2012-12-18
  FDA Approved: MAXITROL — Supplemental Application (Novartis Pharmaceuticals Corporation)

  The FDA approved a supplemental application for MAXITROL, a combination ophthalmic solution containing neomycin sulfate, polymyxin B sulfate…

• FDA approval · 2012-10-02
  FDA Approved: LOTEPREDNOL ETABONATE AND TOBRAMYCIN — Supplemental Application (Bausch & Lomb Americas Inc.)

  The FDA approved a supplemental application for the Loteprednol etabonate and tobramycin ophthalmic suspension by Bausch & Lomb Americas Inc…

• FDA approval · 2011-10-07
  FDA Approved: VIGAMOX — Supplemental Application (Harrow Eye, LLC)

  The FDA approved a supplemental application for VIGAMOX (moxifloxacin hydrochloride) submitted by Harrow Eye, LLC.

• FDA approval · 2010-08-03
  FDA Approved: TOBRADEX ST — Supplemental Application (Harrow Eye, LLC)

  FDA approved a supplemental application for TOBRADEX ST (tobramycin/dexamethasone) from Harrow Eye, LLC.

• FDA approval · 2010-06-03
  FDA Approved: LOTEPREDNOL ETABONATE AND TOBRAMYCIN — Supplemental Application (Bausch & Lomb Americas Inc.)

  FDA approved a supplemental application for Loteprednol etabonate and tobramycin, expanding labeling to treat inflammatory ocular conditions…

• FDA approval · 2010-05-18
  FDA Approved: ZYMAXID — Original Application (Allergan, Inc.)

  FDA approved ZYMAXID (gatifloxacin) through Allergan's original NDA for the treatment of bacterial conjunctivitis.

• FDA approval · 2009-05-28
  FDA Approved: BESIVANCE — Original Application (Bausch & Lomb Americas Inc.)

  The FDA approved Besivance (besifloxacin) in its original application for the treatment of bacterial conjunctivitis.

• FDA approval · 2009-02-13
  FDA Approved: TOBRADEX ST — Original Application (Harrow Eye, LLC)

  The FDA approved TOBRADEX ST (tobramycin/dexamethasone) from Harrow Eye, LLC via an original NDA for treating ocular infections and inflamma…

• FDA approval · 2008-11-06
  FDA Approved: TOBRAMYCIN AND DEXAMETHASONE — Supplemental Application (Bausch & Lomb Incorporated)

  FDA approved a supplemental application for Tobramycin and Dexamethasone from Bausch & Lomb, approving changes to the already-approved ophth…

• FDA approval · 2008-09-15
  FDA Approved: NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE — Supplemental Application (Sandoz Inc.)

  FDA approved a supplemental application for NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE (Sandoz) to support a generic version of thi…

• FDA approval · 2007-04-27
  FDA Approved: AZASITE — Original Application (Thea Pharma Inc.)

  FDA approved the original application for AZASITE (azithromycin monohydrate) for the treatment of bacterial conjunctivitis; the product is m…

• FDA approval · 2006-08-07
  FDA Approved: LOTEPREDNOL ETABONATE AND TOBRAMYCIN — Supplemental Application (Bausch & Lomb Americas Inc.)

  The FDA approved a supplemental application for the ophthalmic combination Loteprednol etabonate and tobramycin (brand Zylet) from Bausch & …