Pulmonary Arterial Hypertension

• FDA approval · 2014-12-22
  FDA Approved: REMODULIN — Supplemental Application (United Therapeutics Corporation)

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

• FDA approval · 2014-10-29
  FDA Approved: LETAIRIS — Supplemental Application (Gilead Sciences, Inc.)

  FDA approved a supplemental application for LETAIRIS (ambrisentan) submitted by Gilead Sciences, Inc. The action involves updating the produ…

• FDA approval · 2014-10-06
  FDA Approved: ORENITRAM — Supplemental Application (United Therapeutics Corporation)

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

• FDA approval · 2014-09-26
  FDA Approved: LETAIRIS — Supplemental Application (Gilead Sciences, Inc.)

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

• FDA approval · 2014-08-21
  FDA Approved: REVATIO — Supplemental Application (Viatris Specialty LLC)

  The FDA approved Viatris Specialty LLC's supplemental application for REVATIO (sildenafil citrate), enabling changes to the drug's approved …

• Want full summaries, importance scores, and drug timelines? Upgrade to Plus or Pro.
• FDA approval · 2014-08-15
  FDA Approved: SILDENAFIL — Supplemental Application (Torrent Pharmaceuticals Limited)

  FDA approved a supplemental application for sildenafil submitted by Torrent Pharmaceuticals Limited.

• FDA approval · 2014-08-01
  FDA Approved: TYVASO — Supplemental Application (United Therapeutics Corporation)

  The FDA approved a supplemental application for TYVASO (treprostinil) from United Therapeutics Corporation. This action constitutes a supple…

• FDA approval · 2014-07-02
  FDA Approved: LETAIRIS — Supplemental Application (Gilead Sciences, Inc.)

  The FDA has approved a supplemental application for LETAIRIS (ambrisentan) by Gilead Sciences. This action updates the product labeling and/…

• FDA approval · 2014-06-11
  FDA Approved: ADEMPAS — Supplemental Application (Bayer HealthCare Pharmaceuticals Inc.)

  FDA approved a supplemental application for ADEMPAS (riociguat) from Bayer HealthCare Pharmaceuticals Inc., approving a supplemental submiss…

• FDA approval · 2014-05-20
  FDA Approved: OPSUMIT — Supplemental Application (Actelion Pharmaceuticals US, Inc.)

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

• FDA approval · 2014-05-06
  FDA Approved: ADEMPAS — Supplemental Application (Bayer HealthCare Pharmaceuticals Inc.)

  FDA approved a supplemental application for ADEMPAS (riociguat) submitted by Bayer HealthCare Pharmaceuticals Inc. The action pertains to th…

• FDA approval · 2014-05-05
  FDA Approved: LETAIRIS — Supplemental Application (Gilead Sciences, Inc.)

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

• FDA approval · 2014-04-29
  FDA Approved: ADCIRCA — Supplemental Application (United Therapeutics Corporation)

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

• FDA approval · 2014-03-11
  FDA Approved: SILDENAFIL CITRATE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approved a supplemental application for sildenafil citrate from Mylan Pharmaceuticals, authorizing a generic sildenafil citrate product.…

• FDA approval · 2014-03-11
  FDA Approved: REVATIO — Supplemental Application (PFIZER LABORATORIES DIV PFIZER INC)

  The FDA approved a supplemental NDA for Revatio (sildenafil citrate) submitted by Pfizer Laboratories Div Pfizer Inc.

• FDA approval · 2014-03-11
  FDA Approved: REVATIO — Supplemental Application (Viatris Specialty LLC)

  The FDA approved a supplemental application for Revatio (sildenafil citrate) filed by Viatris Specialty LLC.

• FDA approval · 2014-03-11
  FDA Approved: REVATIO — Supplemental Application (Viatris Specialty LLC)

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

• FDA approval · 2014-03-06
  FDA Approved: REVATIO — Supplemental Application (Viatris Specialty LLC)

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

• FDA approval · 2014-03-06
  FDA Approved: REVATIO — Supplemental Application (Viatris Specialty LLC)

  FDA approved a supplemental application for REVATIO (sildenafil citrate) submitted by Viatris Specialty LLC. The action expands the approved…

• FDA approval · 2014-01-31
  FDA Approved: LETAIRIS — Supplemental Application (Gilead Sciences, Inc.)

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

• FDA approval · 2014-01-31
  FDA Approved: REVATIO — Supplemental Application (Viatris Specialty LLC)

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

• FDA approval · 2014-01-31
  FDA Approved: REVATIO — Supplemental Application (Viatris Specialty LLC)

  The FDA approved a supplemental application for REVATIO (sildenafil citrate) from Viatris Specialty LLC, updating labeling for the product.

• FDA approval · 2014-01-03
  FDA Approved: REMODULIN — Supplemental Application (United Therapeutics Corporation)

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

• FDA approval · 2013-12-20
  FDA Approved: ORENITRAM — Original Application (United Therapeutics Corporation)

  The FDA approved ORENITRAM (treprostinil) under an Original NDA from United Therapeutics, providing an oral formulation for pulmonary arteri…

• FDA approval · 2013-11-20
  FDA Approved: ADCIRCA — Supplemental Application (United Therapeutics Corporation)

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