Musculoskeletal Pain

• FDA approval · 2020-12-30
  FDA Approved: DULOXETINE — Supplemental Application (Camber Pharmaceuticals, Inc.)

  The FDA approved Camber Pharmaceuticals' supplemental application for duloxetine (ANDA204343), enabling the continued marketing of the gener…

• FDA approval · 2020-08-12
  FDA Approved: METHOCARBAMOL — Original Application (Aurobindo Pharma Limited)

  The FDA approved Aurobindo Pharma Limited's original application for methocarbamol, granting generic approval for this muscle relaxant. This…

• FDA approval · 2020-07-21
  FDA Approved: CHLORZOXAZONE — Original Application (Mayne Pharma Commercial LLC)

  FDA approved Mayne Pharma's original application for chlorzoxazone, a generic skeletal muscle relaxant indicated for relief of muscle spasm …

• FDA approval · 2020-07-06
  FDA Approved: CYCLOBENZAPRINE HYDROCHLORIDE — Original Application (Unichem Pharmaceuticals (USA), Inc.)

  FDA approved cyclobenzaprine hydrochloride as a generic drug under an original ANDA from Unichem Pharmaceuticals (USA), Inc.

• FDA approval · 2020-04-24
  FDA Approved: CARISOPRODOL — Supplemental Application (Ingenus Pharmaceuticals, LLC)

  FDA approved a supplemental application for carisoprodol from Ingenus Pharmaceuticals, LLC, granting approval of a generic version of the mu…

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• FDA approval · 2020-04-20
  FDA Approved: CYMBALTA — Supplemental Application (Eli Lilly and Company)

  FDA approved a supplemental application for Cymbalta (duloxetine hydrochloride) from Eli Lilly, granting updated labeling under the NDA.

• FDA approval · 2019-09-23
  FDA Approved: METAXALONE — Supplemental Application (Amneal Pharmaceuticals LLC)

  FDA approved a supplemental application for Metaxalone (METAXALONE) from Amneal Pharmaceuticals LLC under ANDA203399.

• FDA approval · 2019-09-12
  FDA Approved: CHLORZOXAZONE — Original Application (Novitium Pharma LLC)

  FDA approved the original application for chlorzoxazone, a muscle relaxant, with Novitium Pharma LLC as the manufacturer.

• FDA approval · 2019-08-16
  FDA Approved: DULOXETINE HYDROCHLORIDE — Original Application (Yaopharma Co., Ltd.)

  FDA approved the original application for duloxetine hydrochloride from Yaopharma Co., Ltd., granting approval for the generic product to be…

• FDA approval · 2019-05-22
  FDA Approved: DULOXETINE — Supplemental Application (Zydus Lifesciences Limited)

  FDA approves a supplemental application for a generic duloxetine from Zydus Lifesciences Limited, authorizing marketing of the product.

• FDA approval · 2019-04-17
  FDA Approved: DULOXETINE — Original Application (Qingdao BAHEAL Pharmaceutical Co., Ltd.)

  FDA approved a generic version of duloxetine from Qingdao BAHEAL Pharmaceutical Co., Ltd. under an Original Application (ANDA 210599). The a…

• FDA approval · 2019-04-04
  FDA Approved: SOMA — Supplemental Application (Viatris Specialty LLC)

  FDA approved a supplemental application for Soma (carisoprodol) submitted by Viatris Specialty LLC.

• FDA approval · 2018-11-13
  FDA Approved: CARISOPRODOL — Supplemental Application (Rising Pharma Holdings, Inc.)

  The FDA approved a supplemental application for Carisoprodol from Rising Pharma Holdings, Inc., completing a supplemental approval for this …

• FDA approval · 2018-08-22
  FDA Approved: SOMA — Supplemental Application (Viatris Specialty LLC)

  The FDA approved a supplemental application for Soma (carisoprodol) submitted by Viatris Specialty LLC, updating the product's labeling.

• FDA approval · 2018-07-19
  FDA Approved: DULOXETINE — Supplemental Application (Camber Pharmaceuticals, Inc.)

  FDA approved Camber Pharmaceuticals' supplemental ANDA for a generic duloxetine product (ANDA204343). Duloxetine is indicated for major depr…

• FDA approval · 2018-05-07
  FDA Approved: METHOCARBAMOL — Original Application (Granules Pharmaceuticals Inc.)

  FDA approved Granules Pharmaceuticals Inc.'s original application for methocarbamol tablets, a skeletal muscle relaxant used for short-term …

• FDA approval · 2018-03-13
  FDA Approved: CYCLOBENZAPRINE HYDROCHLORIDE — Supplemental Application (Upsher-Smith Laboratories, LLC)

  The FDA approved a supplemental application for cyclobenzaprine hydrochloride (Upsher-Smith Laboratories, LLC).

• FDA approval · 2017-08-31
  FDA Approved: METAXALONE — Original Application (BluePoint Laboratories)

  FDA approved the original application for metaxalone as a generic (ANDA 207466) manufactured by BluePoint Laboratories for relief of muscle …

• FDA approval · 2017-07-21
  FDA Approved: METHOCARBAMOL — Original Application (UNICHEM PHARMACEUTICALS (USA), INC.)

  FDA approved the original application for a generic methocarbamol product from UNICHEM Pharmaceuticals (USA), Inc.

• FDA approval · 2017-07-18
  FDA Approved: METHOCARBAMOL — Original Application (Sagent Pharmaceuticals)

  The FDA approved Sagent Pharmaceuticals’ original application for methocarbamol (generic). It covers its use as a muscle-relaxant for short-…

• FDA approval · 2017-06-15
  FDA Approved: METAXALONE — Original Application (Actavis Pharma, Inc.)

  FDA approved Actavis Pharma, Inc.'s generic Metaxalone under an Original Application for relief of muscle spasm associated with musculoskele…

• FDA approval · 2017-05-31
  FDA Approved: CYCLOBENZAPRINE HYDROCHLORIDE — Original Application (Advagen Pharma Limited)

  FDA approved Cyclobenzaprine hydrochloride as an original application generic product manufactured by Advagen Pharma Limited.

• 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 · 2017-05-11
  FDA Approved: CARISOPRODOL — Original Application (Westminster Pharmaceuticals, LLC)

  The FDA approved Westminster Pharmaceuticals, LLC's original application for Carisoprodol (generic) to treat short-term relief of discomfort…

• FDA approval · 2017-04-13
  FDA Approved: PIROXICAM — Original Application (Unichem Pharmaceuticals (USA), Inc.)

  FDA approved Unichem Pharmaceuticals (USA), Inc.'s Original Application for piroxicam, authorizing a generic version of the NSAID piroxicam.