Pulmonary Arterial Hypertension

• FDA approval · 2019-02-05
  FDA Approved: TADALAFIL — Original Application (Lupin Pharmaceuticals, Inc.)

  FDA approved Lupin Pharmaceuticals' generic tadalafil under an Original Application (ANDA), enabling a new generic version of tadalafil for …

• FDA approval · 2019-02-01
  FDA Approved: OPSUMIT — Supplemental Application (Actelion Pharmaceuticals US, Inc.)

  FDA approved a supplemental application for OPSUMIT (macitentan) from Actelion Pharmaceuticals US, Inc., resulting in an update to the label…

• FDA approval · 2018-12-12
  FDA Approved: FLOLAN — Supplemental Application (GlaxoSmithKline LLC)

  The FDA approved a supplemental application for FLOLAN (epoprostenol sodium) submitted by GlaxoSmithKline LLC.

• FDA approval · 2018-12-06
  FDA Approved: ADEMPAS — Supplemental Application (Bayer HealthCare Pharmaceuticals Inc.)

  FDA approved a supplemental application for ADEMPAS (riociguat) filed by Bayer HealthCare Pharmaceuticals Inc.

• FDA approval · 2018-11-30
  FDA Approved: LETAIRIS — Supplemental Application (Gilead Sciences, Inc.)

  FDA approved a supplemental application for LETAIRIS (ambrisentan) filed by Gilead Sciences, Inc.

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• FDA approval · 2018-11-20
  FDA Approved: TREPROSTINIL — Supplemental Application (Sandoz Inc)

  FDA approved a supplemental application for a generic Treprostinil water solution from Sandoz Inc.

• FDA approval · 2018-10-25
  FDA Approved: TRACLEER — Supplemental Application (Actelion Pharmaceuticals US, Inc.)

  FDA approved a supplemental application for TRACLEER (bosentan) submitted by Actelion Pharmaceuticals US, Inc., updating the product's label…

• FDA approval · 2018-10-25
  FDA Approved: TRACLEER — Supplemental Application (Actelion Pharmaceuticals US, Inc.)

  FDA approved a supplemental application for Tracleer (bosentan) submitted by Actelion Pharmaceuticals US, Inc.

• FDA approval · 2018-10-23
  FDA Approved: FLOLAN — Supplemental Application (GlaxoSmithKline LLC)

  The FDA approved a supplemental application for FLOLAN (epoprostenol sodium) from GlaxoSmithKline LLC, reflecting an approved change to the …

• FDA approval · 2018-10-16
  FDA Approved: OPSUMIT — Supplemental Application (Actelion Pharmaceuticals US, Inc.)

  FDA approved a supplemental application for OPSUMIT (macitentan) submitted by Actelion Pharmaceuticals US, Inc.

• FDA approval · 2018-07-30
  FDA Approved: REMODULIN — Supplemental Application (United Therapeutics Corporation)

  The FDA approved a supplemental application for REMODULIN (treprostinil) by United Therapeutics Corporation.

• FDA approval · 2018-06-27
  FDA Approved: SILDENAFIL — Original Application (Amneal Pharmaceuticals NY LLC)

  The FDA approved Amneal Pharmaceuticals NY LLC's original application for sildenafil, enabling a generic sildenafil product under ANDA 20202…

• FDA approval · 2018-06-11
  FDA Approved: SILDENAFIL — Original Application (XLCARE Pharmaceuticals INC.)

  FDA approved sildenafil as a generic drug under an Original Application (ANDA 202659) for XLCARE Pharmaceuticals Inc.

• FDA approval · 2018-06-11
  FDA Approved: SILDENAFIL — Original Application (Aurobindo Pharma Limited)

  FDA approved the original application for sildenafil, granting a generic version of the erectile dysfunction drug to Aurobindo Pharma Limite…

• FDA approval · 2018-06-11
  FDA Approved: SILDENAFIL — Original Application (Advagen Pharma Ltd)

  FDA approved a sildenafil generic from Advagen Pharma Ltd under Original Application, enabling a generic version with the established indica…

• FDA approval · 2018-06-08
  FDA Approved: REMODULIN — Supplemental Application (United Therapeutics Corporation)

  The FDA approved a supplemental application for REMODULIN (treprostinil) submitted by United Therapeutics Corporation. The action approves t…

• FDA approval · 2018-05-14
  FDA Approved: FLOLAN — Supplemental Application (GlaxoSmithKline LLC)

  FDA approved a supplemental application for FLOLAN (epoprostenol sodium) from GlaxoSmithKline LLC.

• FDA approval · 2018-04-18
  FDA Approved: TREPROSTINIL — Supplemental Application (Sandoz Inc)

  FDA approved a supplemental application from Sandoz Inc for TREPROSTINIL, adding a water solution formulation of treprostinil.

• FDA approval · 2018-02-01
  FDA Approved: REVATIO — Supplemental Application (PFIZER LABORATORIES DIV PFIZER INC)

  The FDA approved Pfizer's supplemental application for Revatio (sildenafil citrate), indicating FDA approval of the requested changes to the…

• FDA approval · 2018-01-11
  FDA Approved: ADEMPAS — Supplemental Application (Bayer HealthCare Pharmaceuticals Inc.)

  FDA approves a supplemental application for ADEMPAS (riociguat) submitted by Bayer HealthCare Pharmaceuticals Inc.

• FDA approval · 2017-12-14
  FDA Approved: SILDENAFIL CITRATE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  The FDA approved a supplemental application for sildenafil citrate submitted by Mylan Pharmaceuticals Inc., resulting in an approved modific…

• FDA approval · 2017-11-30
  FDA Approved: TREPROSTINIL — Original Application (Sandoz Inc)

  FDA approved an original-application generic Treprostinil water solution from Sandoz Inc for the treatment of pulmonary arterial hypertensio…

• FDA approval · 2017-10-20
  FDA Approved: TRACLEER — Supplemental Application (Actelion Pharmaceuticals US, Inc.)

  FDA approved a supplemental application for Tracleer (bosentan) from Actelion Pharmaceuticals US, expanding its regulatory approval. The act…

• FDA approval · 2017-10-20
  FDA Approved: TRACLEER — Supplemental Application (Actelion Pharmaceuticals US, Inc.)

  FDA notes Actelion's supplemental NDA for Tracleer (bosentan) and the agency's approval of the supplemental application.

• FDA approval · 2017-10-19
  FDA Approved: TYVASO — Supplemental Application (United Therapeutics Corporation)

  FDA approved a supplemental application for TYVASO (treprostinil) filed by United Therapeutics Corporation.