Pulmonary Arterial Hypertension

• FDA approval · 2013-10-18
  FDA Approved: OPSUMIT — Original Application (Actelion Pharmaceuticals US, Inc.)

  FDA approved OPSUMIT (macitentan) under the original application, for the treatment of pulmonary arterial hypertension.

• FDA approval · 2013-10-08
  FDA Approved: ADEMPAS — Original Application (Bayer HealthCare Pharmaceuticals Inc.)

  The FDA approved Adempas (riociguat) from Bayer as the original application for treatment of pulmonary arterial hypertension and chronic thr…

• FDA approval · 2013-09-26
  FDA Approved: REMODULIN — Supplemental Application (United Therapeutics Corporation)

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

• FDA approval · 2013-08-17
  FDA Approved: LETAIRIS — Supplemental Application (Gilead Sciences, Inc.)

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

• FDA approval · 2013-07-01
  FDA Approved: TRACLEER — Supplemental Application (Actelion Pharmaceuticals US, Inc.)

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

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• FDA approval · 2013-06-03
  FDA Approved: TRACLEER — Supplemental Application (Actelion Pharmaceuticals US, Inc.)

  The FDA approved a supplemental application for TRACLEER (bosentan) by Actelion Pharmaceuticals US, Inc., facilitating changes to the drug's…

• FDA approval · 2013-04-30
  FDA Approved: TYVASO — Supplemental Application (United Therapeutics Corporation)

  The FDA approved a supplemental application for TYVASO (treprostinil) submitted by United Therapeutics Corporation. The exact changes to lab…

• FDA approval · 2013-02-28
  FDA Approved: SILDENAFIL — Original Application (Amneal Pharmaceuticals of New York LLC)

  FDA approves Amneal Pharmaceuticals of New York LLC's generic sildenafil under an original ANDA, for the same indications as the brand produ…

• FDA approval · 2013-01-16
  FDA Approved: LETAIRIS — Supplemental Application (Gilead Sciences, Inc.)

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

• FDA approval · 2013-01-07
  FDA Approved: TYVASO — Supplemental Application (United Therapeutics Corporation)

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

• FDA approval · 2012-12-10
  FDA Approved: SILDENAFIL — Supplemental Application (Chartwell RX, LLC)

  FDA approved a supplemental application for sildenafil submitted by Chartwell RX, LLC under ANDA202598.

• FDA approval · 2012-11-06
  FDA Approved: SILDENAFIL — Original Application (Chartwell RX, LLC)

  FDA approved Chartwell RX, LLC's original ANDA for sildenafil, authorizing a generic version of sildenafil citrate.

• FDA approval · 2012-10-19
  FDA Approved: LETAIRIS — Supplemental Application (Gilead Sciences, Inc.)

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

• FDA approval · 2012-10-04
  FDA Approved: TRACLEER — Supplemental Application (Actelion Pharmaceuticals US, Inc.)

  FDA approved a supplemental application for Tracleer (bosentan) filed by Actelion Pharmaceuticals US, Inc. to update/expand the labeling for…

• FDA approval · 2012-10-02
  FDA Approved: TRACLEER — Supplemental Application (Actelion Pharmaceuticals US, Inc.)

  FDA approved a supplemental application for Tracleer (bosentan) from Actelion Pharmaceuticals US, Inc. The supplement updates the approved l…

• FDA approval · 2012-08-30
  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 · 2012-08-30
  FDA Approved: REVATIO — Original Application (Viatris Specialty LLC)

  The FDA approved the original application for REVATIO (sildenafil citrate) filed by Viatris Specialty LLC. This approval supports the use of…

• FDA approval · 2012-08-30
  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 · 2012-06-28
  FDA Approved: VELETRI — Supplemental Application (Actelion Pharmaceuticals US, Inc.)

  FDA approved a supplemental application for VELETRI (epoprostenol) by Actelion Pharmaceuticals US, expanding its labeling.

• FDA approval · 2012-02-15
  FDA Approved: LETAIRIS — Supplemental Application (Gilead Sciences, Inc.)

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

• FDA approval · 2011-07-19
  FDA Approved: LETAIRIS — Supplemental Application (Gilead Sciences, Inc.)

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

• FDA approval · 2011-03-30
  FDA Approved: VELETRI — Supplemental Application (Actelion Pharmaceuticals US, Inc.)

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

• FDA approval · 2011-03-29
  FDA Approved: FLOLAN — Supplemental Application (GlaxoSmithKline LLC)

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

• FDA approval · 2011-03-03
  FDA Approved: LETAIRIS — Supplemental Application (Gilead Sciences, Inc.)

  The FDA approved a supplemental application for LETAIRIS (ambrisentan) submitted by Gilead Sciences, Inc. The approval reflects changes requ…

• FDA approval · 2011-02-08
  FDA Approved: REMODULIN — Supplemental Application (United Therapeutics Corporation)

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