Osteoarthritis

• FDA approval · 2016-08-15
  FDA Approved: MELOXICAM — Supplemental Application (Zydus Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for MELOXICAM from Zydus Pharmaceuticals USA Inc., granting approval to market generic meloxicam in …

• FDA approval · 2016-08-03
  FDA Approved: DULOXETINE — Original Application (Camber Pharmaceuticals, Inc.)

  The FDA approved Camber Pharmaceuticals' original application for a generic duloxetine product. Duloxetine is used to treat multiple conditi…

• FDA approval · 2016-05-09
  FDA Approved: TOLMETIN SODIUM — Supplemental Application (Atland Pharmaceuticals, LLC)

  The FDA approved a supplemental application for Tolmetin sodium submitted by Atland Pharmaceuticals, LLC under ANDA073393.

• FDA approval · 2016-05-09
  FDA Approved: TOLMETIN SODIUM — Supplemental Application (Atland Pharmaceuticals, LLC)

  FDA approved a supplemental application for tolmetin sodium submitted by Atland Pharmaceuticals, LLC.

• FDA approval · 2016-05-09
  FDA Approved: ETODOLAC — Supplemental Application (ANI Pharmaceuticals, Inc.)

  FDA approved a supplemental application for etodolac from ANI Pharmaceuticals, Inc., granting regulatory approval for a change to the produc…

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• FDA approval · 2016-05-09
  FDA Approved: NABUMETONE — Supplemental Application (Chartwell RX, LLC)

  The FDA approved a supplemental application for nabumetone submitted by Chartwell RX, LLC.

• FDA approval · 2016-05-09
  FDA Approved: SULINDAC — Supplemental Application (Actavis Pharma, Inc.)

  FDA approved a supplemental application for sulindac from Actavis Pharma, Inc.

• FDA approval · 2016-05-09
  FDA Approved: VOLTAREN ARTHRITIS PAIN — Supplemental Application (Haleon US Holdings LLC)

  The FDA approved a supplemental application for Voltaren Arthritis Pain (diclofenac sodium) submitted by Haleon US Holdings LLC.

• FDA approval · 2016-05-09
  FDA Approved: DICLOFENAC SODIUM — Supplemental Application (Aurobindo Pharma Limited)

  The FDA approved a supplemental application for diclofenac sodium from Aurobindo Pharma Limited.

• FDA approval · 2016-05-09
  FDA Approved: NABUMETONE — Supplemental Application (ScieGen Pharmaceuticals Inc)

  FDA approved a supplemental application for Nabumetone from ScieGen Pharmaceuticals Inc. The action updates the product's labeling based on …

• FDA approval · 2016-05-09
  FDA Approved: INDOMETHACIN — Supplemental Application (Amneal Pharmaceuticals LLC)

  FDA approves Amneal's supplemental application for INDOMETHACIN, marking an approved modification to the product under an ANDA.

• FDA approval · 2016-05-09
  FDA Approved: INDOMETHACIN — Supplemental Application (Camber Pharmaceuticals, Inc.)

  FDA approved Camber Pharmaceuticals' supplemental application for Indomethacin, resulting in updated labeling for the product.

• FDA approval · 2016-05-09
  FDA Approved: ETODOLAC — Supplemental Application (Taro Pharmaceuticals U.S.A., Inc.)

  FDA approved a supplemental application for etodolac submitted by Taro Pharmaceuticals U.S.A., Inc.

• FDA approval · 2016-05-09
  FDA Approved: NAPROXEN — Supplemental Application (Zameer Pharmaceuticals LLC)

  FDA approved a supplemental application for Naproxen submitted by Zameer Pharmaceuticals LLC.

• FDA approval · 2016-05-09
  FDA Approved: DAYPRO — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)

  FDA approved a supplemental application for DAYPRO (oxaprozin) from Pfizer Laboratories Div Pfizer Inc.

• FDA approval · 2016-05-09
  FDA Approved: DICLOFENAC SODIUM AND MISOPROSTOL — Supplemental Application (Mylan Pharmaceuticals Inc.)

  The FDA approved a supplemental application for diclofenac sodium and misoprostol from Mylan Pharmaceuticals Inc., marking an approved chang…

• FDA approval · 2016-05-09
  FDA Approved: NABUMETONE — Supplemental Application (Exelan Pharmaceuticals Inc.)

  The FDA approved a supplemental application for Nabumetone from Exelan Pharmaceuticals Inc. This action typically updates labeling or adds a…

• FDA approval · 2016-05-09
  FDA Approved: NABUMETONE — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for Nabumetone filed by Lupin Pharmaceuticals, indicating an update to the drug's labeling or fo…

• FDA approval · 2016-05-09
  FDA Approved: SULINDAC — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved a supplemental application for Sulindac from Sun Pharmaceutical Industries, Inc.

• FDA approval · 2016-05-09
  FDA Approved: ETODOLAC — Supplemental Application (Apotex Corp.)

  FDA approves a supplemental application for etodolac by Apotex Corp., updating the approval status of this generic NSAID.

• FDA approval · 2016-05-05
  FDA Approved: TYLENOL 8 HR ARTHRITIS PAIN — Supplemental Application (Kenvue Brands LLC)

  The FDA approved a supplemental application for TYLENOL 8 HR ARTHRITIS PAIN (acetaminophen) submitted by Kenvue Brands LLC.

• FDA approval · 2016-04-20
  FDA Approved: MELOXICAM — Supplemental Application (Zydus Pharmaceuticals USA Inc.)

  The FDA approved a supplemental application for MELOXICAM submitted by Zydus Pharmaceuticals USA Inc. This action constitutes a supplemental…

• FDA approval · 2016-03-18
  FDA Approved: ARTHRITIS PAIN RELIEVER — Original Application (CVS PHARMACY, INC)

  FDA approves CVS Pharmacy, Inc.'s Arthritis Pain Reliever as an original generic application for diclofenac sodium. The product is an NSAID …

• FDA approval · 2016-03-16
  FDA Approved: CELECOXIB — Original Application (McKesson Corporation dba SKY Packaging)

  FDA approved the original Abbreviated New Drug Application for a generic celecoxib product manufactured by McKesson Corporation dba SKY Pack…

• FDA approval · 2016-02-25
  FDA Approved: ALEVE GELCAPS — Supplemental Application (Bayer HealthCare LLC.)

  The FDA approved a supplemental application to bring ALEVE GELCAPS (naproxen sodium) to market as a new dosage form from Bayer HealthCare LL…