Pulmonary Arterial Hypertension

• FDA approval · 2016-01-22
  FDA Approved: REMODULIN — Supplemental Application (United Therapeutics Corporation)

  The FDA approved a supplemental application for Remodulin (treprostinil) submitted by United Therapeutics Corporation. This action pertains …

• FDA approval · 2016-01-15
  FDA Approved: SILDENAFIL — Supplemental Application (Chartwell RX, LLC)

  FDA approved a supplemental application for sildenafil (generic) filed by Chartwell RX, LLC.

• FDA approval · 2015-12-21
  FDA Approved: UPTRAVI — Original Application (Actelion Pharmaceuticals US, Inc.)

  FDA approved UPTRAVI (selexipag) from Actelion Pharmaceuticals US, Inc. as the original approval for the treatment of pulmonary arterial hyp…

• FDA approval · 2015-12-17
  FDA Approved: SILDENAFIL — Supplemental Application (Torrent Pharmaceuticals Limited)

  FDA approved Torrent Pharmaceuticals Limited's supplemental application for sildenafil (generic).

• FDA approval · 2015-12-04
  FDA Approved: ADEMPAS — Supplemental Application (Bayer HealthCare Pharmaceuticals Inc.)

  The FDA approved a supplemental application for ADEMPAS (riociguat) from Bayer HealthCare Pharmaceuticals Inc. This action updates the exist…

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• FDA approval · 2015-12-04
  FDA Approved: TRACLEER — Supplemental Application (Actelion Pharmaceuticals US, Inc.)

  The FDA approved a supplemental application for TRACLEER (bosentan) from Actelion to update the drug's labeling.

• FDA approval · 2015-11-19
  FDA Approved: SILDENAFIL — Supplemental Application (Eugia US LLC)

  FDA approves a supplemental application for sildenafil citrate by Eugia US LLC (ANDA 203988) for a generic sildenafil product.

• FDA approval · 2015-11-18
  FDA Approved: SILDENAFIL — Original Application (Aurobindo Pharma Limited)

  FDA approved Aurobindo Pharma Limited's Original Application for sildenafil, granting a generic version of sildenafil tablets.

• FDA approval · 2015-11-17
  FDA Approved: OPSUMIT — Supplemental Application (Actelion Pharmaceuticals US, Inc.)

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

• FDA approval · 2015-10-26
  FDA Approved: SILDENAFIL — Supplemental Application (Macleods Pharmaceuticals Limited)

  FDA approved a supplemental application for sildenafil from Macleods Pharmaceuticals Limited. This action updates the already approved produ…

• FDA approval · 2015-10-02
  FDA Approved: LETAIRIS — Supplemental Application (Gilead Sciences, Inc.)

  The FDA approved a supplemental application for LETAIRIS (ambrisentan) from Gilead Sciences, Inc.

• FDA approval · 2015-09-25
  FDA Approved: LETAIRIS — Supplemental Application (Gilead Sciences, Inc.)

  The FDA approved a supplemental application for LETAIRIS (ambrisentan) submitted by Gilead Sciences, Inc., updating the drug’s labeling as p…

• FDA approval · 2015-09-16
  FDA Approved: SILDENAFIL CITRATE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approved a supplemental application for sildenafil citrate by Mylan Pharmaceuticals Inc., supporting its generic sildenafil citrate prod…

• FDA approval · 2015-06-23
  FDA Approved: TYVASO — Supplemental Application (United Therapeutics Corporation)

  FDA approved a supplemental application for TYVASO (treprostinil) submitted by United Therapeutics Corporation. The action updates the produ…

• FDA approval · 2015-06-04
  FDA Approved: REVATIO — Supplemental Application (Viatris Specialty LLC)

  FDA approved a supplemental application for REVATIO (sildenafil citrate) submitted by Viatris Specialty LLC.

• FDA approval · 2015-04-27
  FDA Approved: REVATIO — Supplemental Application (Viatris Specialty LLC)

  FDA approves a supplemental application for REVATIO (sildenafil citrate) submitted by Viatris Specialty LLC.

• FDA approval · 2015-04-27
  FDA Approved: REVATIO — Supplemental Application (PFIZER LABORATORIES DIV PFIZER INC)

  The FDA approved a supplemental application for Revatio (sildenafil citrate) from Pfizer Laboratories Div Pfizer Inc.

• FDA approval · 2015-04-27
  FDA Approved: REVATIO — Supplemental Application (Viatris Specialty LLC)

  FDA is handling a supplemental approval application for Revatio (sildenafil citrate) submitted by Viatris Specialty LLC.

• FDA approval · 2015-04-17
  FDA Approved: FLOLAN — Supplemental Application (GlaxoSmithKline LLC)

  The FDA approved a supplemental application for FLOLAN (epoprostenol sodium) submitted by GlaxoSmithKline LLC. The approval updates the drug…

• FDA approval · 2015-04-02
  FDA Approved: ADCIRCA — Supplemental Application (United Therapeutics Corporation)

  The FDA approved a supplemental application for ADCIRCA (tadalafil) submitted by United Therapeutics Corporation.

• FDA approval · 2015-04-02
  FDA Approved: SILDENAFIL — Supplemental Application (Macleods Pharmaceuticals Limited)

  The FDA approved a supplemental application for sildenafil submitted by Macleods Pharmaceuticals Limited. This action authorizes changes und…

• FDA approval · 2015-03-18
  FDA Approved: SILDENAFIL — Supplemental Application (Amneal Pharmaceuticals of New York LLC)

  FDA approves Amneal Pharmaceuticals of New York LLC's supplemental application for a generic sildenafil product.

• FDA approval · 2015-03-03
  FDA Approved: VELETRI — Supplemental Application (Actelion Pharmaceuticals US, Inc.)

  FDA approved a supplemental application for VELETRI (epoprostenol) from Actelion Pharmaceuticals US, Inc., reflecting an update to the produ…

• FDA approval · 2015-02-23
  FDA Approved: ADEMPAS — Supplemental Application (Bayer HealthCare Pharmaceuticals Inc.)

  FDA approved Bayer HealthCare Pharmaceuticals Inc.'s supplemental application for ADEMPAS (riociguat).

• FDA approval · 2015-01-26
  FDA Approved: SILDENAFIL CITRATE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approved a supplemental application for sildenafil citrate (generic) filed by Mylan Pharmaceuticals Inc. The action pertains to a supple…