Diabetic Peripheral Neuropathy

• FDA approval · 2017-10-11
  FDA Approved: LYRICA CR — Original Application (Viatris Specialty LLC)

  FDA approves LYRICA CR (pregabalin) under an Original Application for an extended-release formulation of pregabalin.

• FDA approval · 2017-05-18
  FDA Approved: DULOXETINE — Original Application (Solco Healthcare US, LLC)

  FDA approved Solco Healthcare US, LLC's original application for duloxetine, enabling the marketing of a generic duloxetine product.

• FDA approval · 2017-01-06
  FDA Approved: DULOXETINE — Original Application (Quallent Pharmaceuticals Health LLC)

  FDA approved an Original Application (ANDA 208706) for duloxetine from Quallent Pharmaceuticals Health LLC, establishing a generic version o…

• FDA approval · 2016-12-22
  FDA Approved: LYRICA — Supplemental Application (Parke-Davis Div of Pfizer Inc)

  The FDA approved a supplemental application for LYRICA (pregabalin) submitted by Parke-Davis Division of Pfizer Inc.

• FDA approval · 2016-09-30
  FDA Approved: TAPENTADOL — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for Tapentadol hydrochloride submitted by Hikma Pharmaceuticals USA Inc.

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• FDA approval · 2015-12-22
  FDA Approved: DULOXETINE DELAYED-RELEASE — Supplemental Application (Breckenridge Pharmaceutical, Inc.)

  The FDA approved Breckenridge Pharmaceutical's supplemental application for a duloxetine hydrochloride delayed-release product, granting app…

• FDA approval · 2015-10-28
  FDA Approved: DULOXETINE — Original Application (ANI Pharmaceuticals, Inc.)

  The FDA approved ANI Pharmaceuticals' original ANDA for duloxetine, allowing a generic version to be marketed. The approval covers duloxetin…

• FDA approval · 2014-06-11
  FDA Approved: DULOXETINE DELAYED-RELEASE — Original Application (Breckenridge Pharmaceutical, Inc.)

  FDA approved Breckenridge Pharmaceutical's original generic duloxetine hydrochloride delayed-release capsules, a generic version of the anti…

• FDA approval · 2014-01-16
  FDA Approved: TAPENTADOL — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for Tapentadol hydrochloride (generic) submitted by Hikma Pharmaceuticals USA Inc.

• FDA approval · 2013-12-11
  FDA Approved: DULOXETINE — Original Application (Sun Pharmaceutical Industries, Inc.)

  FDA approves Sun Pharmaceutical Industries' original application for a generic duloxetine product (DULOXETINE). This approval allows the mar…

• FDA approval · 2013-12-11
  FDA Approved: DULOXETINE — Original Application (Lupin Pharmaceuticals, Inc.)

  FDA approved Lupin Pharmaceuticals' generic duloxetine under an Original Application, authorizing a generic version of the reference duloxet…

• FDA approval · 2013-07-12
  FDA Approved: GABAPENTIN — Original Application (ACI Healthcare USA, Inc.)

  FDA approved a generic gabapentin product under an Original Application filed by ACI Healthcare USA, Inc.

• FDA approval · 2011-06-20
  FDA Approved: LYRICA — Supplemental Application (Parke-Davis Div of Pfizer Inc)

  FDA approved a supplemental application for LYRICA (pregabalin) submitted by Parke-Davis Div of Pfizer Inc.

• FDA approval · 2011-04-26
  FDA Approved: PREGABALIN — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approved a supplemental application for pregabalin submitted by Mylan Pharmaceuticals Inc., updating the regulatory status of the produc…

• FDA approval · 2011-04-12
  FDA Approved: CYMBALTA — Supplemental Application (Eli Lilly and Company)

  The FDA approved a supplemental application for Cymbalta (duloxetine hydrochloride) submitted by Eli Lilly and Company.

• FDA approval · 2010-11-01
  FDA Approved: TAPENTADOL — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved a supplemental NDA for tapentadol hydrochloride by Hikma Pharmaceuticals USA Inc., allowing a generic version of tapentadol to …

• FDA approval · 2010-01-04
  FDA Approved: PREGABALIN — Original Application (Mylan Pharmaceuticals Inc.)

  FDA approved the original application for pregabalin from Mylan Pharmaceuticals, confirming a generic version of the drug.

• FDA approval · 2007-06-21
  FDA Approved: LYRICA — Supplemental Application (Parke-Davis Div of Pfizer Inc)

  The FDA approved a supplemental application for LYRICA (pregabalin) submitted by Parke-Davis (Pfizer) to update the labeling with expanded o…