Myasthenia Gravis

• FDA approval · 2017-04-26
  FDA Approved: NEOSTIGMINE METHYLSULFATE — Original Application (Par Health USA, LLC)

  FDA approved Par Health USA, LLC's original application for a generic neostigmine methylsulfate product. This marks the availability of a ge…

• FDA approval · 2016-05-18
  FDA Approved: REGONOL — Supplemental Application (Sandoz Inc)

  FDA approved a supplemental application for Regonol (pyridostigmine bromide) submitted by Sandoz Inc.

• FDA approval · 2015-12-28
  FDA Approved: NEOSTIGMINE METHYLSULFATE — Original Application (Civica, Inc.)

  FDA approved Civica, Inc.'s original application for Neostigmine Methylsulfate, a generic version of the drug.

• FDA approval · 2015-12-23
  FDA Approved: PYRIDOSTIGMINE BROMIDE — Supplemental Application (Surgeon General-Department of the Army (TSG-DA))

  FDA approved a supplemental application for pyridostigmine bromide submitted by the Surgeon General, Department of the Army.

• FDA approval · 2015-10-20
  FDA Approved: BLOXIVERZ — Supplemental Application (Exela Pharma Sciences, LLC)

  The FDA approved a supplemental application for BLOXIVERZ (neostigmine methylsulfate) submitted by Exela Pharma Sciences, LLC.

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• FDA approval · 2015-06-22
  FDA Approved: PYRIDOSTIGMINE BROMIDE — Original Application (Zydus Lifesciences Limited)

  FDA approved pyridostigmine bromide from Zydus Lifesciences Limited under an Original Application. The drug is used for symptomatic treatmen…

• FDA approval · 2015-02-23
  FDA Approved: PYRIDOSTIGMINE BROMIDE — Supplemental Application (Oceanside Pharmaceuticals)

  FDA approved a supplemental application for pyridostigmine bromide by Oceanside Pharmaceuticals (brand Mestinon).

• FDA approval · 2015-01-08
  FDA Approved: NEOSTIGMINE METHYLSULFATE — Original Application (Fresenius Kabi USA, LLC)

  FDA approved Fresenius Kabi USA, LLC's NEOSTIGMINE METHYLSULFATE under an Original Application (NDA).

• FDA approval · 2014-12-11
  FDA Approved: BLOXIVERZ — Supplemental Application (Exela Pharma Sciences, LLC)

  FDA approved a supplemental application for BLOXIVERZ (neostigmine methylsulfate) from Exela Pharma Sciences, LLC.

• FDA approval · 2014-09-30
  FDA Approved: BLOXIVERZ — Supplemental Application (Exela Pharma Sciences, LLC)

  FDA approved a supplemental application for BLOXIVERZ (neostigmine methylsulfate) from Exela Pharma Sciences, LLC.

• FDA approval · 2014-07-25
  FDA Approved: PYRIDOSTIGMINE BROMIDE — Supplemental Application (Oceanside Pharmaceuticals)

  FDA approved a supplemental application for pyridostigmine bromide submitted by Oceanside Pharmaceuticals, resulting in updated labeling und…

• FDA approval · 2014-06-18
  FDA Approved: BLOXIVERZ — Supplemental Application (Exela Pharma Sciences, LLC)

  FDA approved a supplemental application for BLOXIVERZ (neostigmine methylsulfate) from Exela Pharma Sciences, LLC.

• FDA approval · 2014-01-09
  FDA Approved: PYRIDOSTIGMINE BROMIDE — Supplemental Application (Oceanside Pharmaceuticals)

  FDA approved a supplemental application for pyridostigmine bromide from Oceanside Pharmaceuticals.

• FDA approval · 2014-01-03
  FDA Approved: PYRIDOSTIGMINE BROMIDE — Supplemental Application (Surgeon General-Department of the Army (TSG-DA))

  FDA has approved a supplemental application for pyridostigmine bromide, submitted by the Surgeon General of the Department of the Army.

• FDA approval · 2014-01-03
  FDA Approved: PYRIDOSTIGMINE BROMIDE — Supplemental Application (Oceanside Pharmaceuticals)

  The FDA approved Oceanside Pharmaceuticals' supplemental application for pyridostigmine bromide.

• FDA approval · 2013-09-26
  FDA Approved: PYRIDOSTIGMINE BROMIDE — Supplemental Application (Oceanside Pharmaceuticals)

  The FDA approved a supplemental application for pyridostigmine bromide submitted by Oceanside Pharmaceuticals.

• FDA approval · 2013-07-22
  FDA Approved: REGONOL — Supplemental Application (Sandoz Inc)

  The FDA approved a supplemental application for Regonol (pyridostigmine bromide) submitted by Sandoz Inc.

• FDA approval · 2010-10-28
  FDA Approved: PYRIDOSTIGMINE BROMIDE — Supplemental Application (Amneal Pharmaceuticals of New York LLC)

  FDA approved a supplemental application for pyridostigmine bromide from Amneal Pharmaceuticals of New York LLC.