Ankylosing Spondylitis

• FDA approval · 2017-04-21
  FDA Approved: RENFLEXIS — Original Application (Organon LLC)

  The FDA approved RENFLEXIS (infliximab) from Organon LLC based on an original application, making it a biosimilar to Remicade. The approval …

• 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.

• FDA approval · 2017-03-10
  FDA Approved: NAPROXEN — Supplemental Application (Zameer Pharmaceuticals LLC)

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

• FDA approval · 2017-01-23
  FDA Approved: NAPROXEN — Original Application (Amerisource Bergen)

  FDA approves AmerisourceBergen's original application for naproxen sodium tablets, a generic naproxen product.

• FDA approval · 2016-11-25
  FDA Approved: DICLOFENAC SODIUM AND MISOPROSTOL — Original Application (Amneal Pharmaceuticals LLC)

  The FDA approved Amneal Pharmaceuticals LLC's diclofenac sodium and misoprostol as an original ANDA, enabling a generic version of the diclo…

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• FDA approval · 2016-09-16
  FDA Approved: CELECOXIB — Supplemental Application (Apotex Corp.)

  The FDA approved Apotex Corp.'s supplemental application for celecoxib (generic) under ANDA204197.

• FDA approval · 2016-09-14
  FDA Approved: CELECOXIB — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for CELECOXIB from Aurobindo Pharma Limited (ANDA206827). This notice confirms the supplemental appr…

• FDA approval · 2016-09-02
  FDA Approved: DICLOFENAC SODIUM — Original Application (SOLA Pharmaceuticals, LLC)

  FDA approved SOLA Pharmaceuticals' diclofenac sodium tablet as an original generic, indicated for relief of pain and inflammation in conditi…

• FDA approval · 2016-06-30
  FDA Approved: HUMIRA — Supplemental Application (Cordavis Limited)

  FDA approved a supplemental application for Humira (adalimumab) to Cordavis Limited, authorizing the continued manufacturing/supply of the p…

• 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: 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: NAPROXEN — Supplemental Application (Zameer Pharmaceuticals LLC)

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

• FDA approval · 2016-04-05
  FDA Approved: INFLECTRA — Original Application (Pfizer Laboratories Div Pfizer Inc)

  FDA approved INFLECTRA (infliximab-dyyb) as a biosimilar to infliximab for multiple autoimmune diseases, expanding access to a biologic ther…

• 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 · 2016-02-22
  FDA Approved: SIMPONI ARIA — Supplemental Application (Janssen Biotech, Inc.)

  The FDA approved a supplemental application for Simponi Aria (golimumab) from Janssen Biotech, Inc., under BLA125433, to update the product …

• FDA approval · 2015-12-23
  FDA Approved: CELECOXIB — Original Application (Torrent Pharmaceuticals Limited)

  FDA approved the original application for generic celecoxib by Torrent Pharmaceuticals Limited. This marks approval of a generic version of …

• FDA approval · 2015-11-23
  FDA Approved: HUMIRA — Supplemental Application (Cordavis Limited)

  The FDA approved a supplemental application for Humira (adalimumab) filed by Cordavis Limited, indicating regulatory action on a Humira supp…

• FDA approval · 2015-09-23
  FDA Approved: CELECOXIB — Original Application (Cipla USA Inc.)

  FDA approves Cipla USA Inc.'s Celecoxib under an Original Application for generic Celecoxib. The approval covers multiple indications common…

• FDA approval · 2015-08-24
  FDA Approved: NAPROXEN — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for Naproxen by Hikma Pharmaceuticals USA Inc., indicating changes to the product's approval.

• FDA approval · 2015-08-21
  FDA Approved: CELECOXIB — Original Application (Alembic Pharmaceuticals Inc.)

  FDA approved Alembic Pharmaceuticals' original application for a generic Celecoxib product. This marks the entry of a generic celecoxib into…

• FDA approval · 2015-06-09
  FDA Approved: CELECOXIB — Original Application (Lupin Pharmaceuticals, Inc.)

  FDA approves Lupin Pharmaceuticals' Original Application for celecoxib, enabling a generic version of Celecoxib to enter the market.

• FDA approval · 2015-05-28
  FDA Approved: SULINDAC — Supplemental Application (PuraCap Laboratories LLC dba Blu Pharmaceuticals)

  The FDA approved a supplemental application for sulindac from PuraCap Laboratories dba Blu Pharmaceuticals, updating the product’s labeling …

• FDA approval · 2015-03-25
  FDA Approved: ENBREL — Supplemental Application (Immunex Corporation)

  FDA approved a supplemental application for ENBREL (etanercept), expanding its label with additional indications. The submission status indi…

• FDA approval · 2015-01-21
  FDA Approved: COSENTYX — Original Application (Novartis Pharmaceuticals Corporation)

  FDA approved the original Biologics License Application for Cosentyx (secukinumab) from Novartis Pharmaceuticals Corporation, establishing i…