Chronic Obstructive Pulmonary Disease

• FDA approval · 2019-11-15
  FDA Approved: PREDNISONE — Original Application (ANI Pharmaceuticals, Inc.)

  The FDA approves ANI Pharmaceuticals' original (generic) application for prednisone, enabling a generic prednisone product to be marketed.

• FDA approval · 2019-09-06
  FDA Approved: ALBUTEROL SULFATE — Original Application (QUAGEN PHARMACEUTICALS LLC)

  FDA approves QUAGEN PHARMACEUTICALS LLC's ALBUTEROL SULFATE original application, granting a generic albuterol sulfate product for relief of…

• FDA approval · 2019-08-12
  FDA Approved: DULERA — Supplemental Application (Organon LLC)

  FDA approved a supplemental application for DULERA (mometasone furoate/formoterol fumarate dihydrate) from Organon LLC.

• FDA approval · 2019-07-22
  FDA Approved: SEREVENT DISKUS — Supplemental Application (GlaxoSmithKline LLC)

  The FDA approved a supplemental application for SEREVENT DISKUS (salmeterol xinafoate) submitted by GlaxoSmithKline LLC.

• FDA approval · 2019-06-06
  FDA Approved: UMECLIDINIUM AND VILANTEROL ELLIPTA — Supplemental Application (Prasco Laboratories)

  FDA approved a supplemental application for UMECLIDINIUM AND VILANTEROL ELLIPTA submitted by Prasco Laboratories for the umeclidinium bromid…

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• FDA approval · 2019-05-29
  FDA Approved: FORMOTEROL FUMARATE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approved a supplemental application for Formoterol Fumarate from Mylan Pharmaceuticals, indicating approval of a supplemental NDA for th…

• FDA approval · 2019-05-29
  FDA Approved: UMECLIDINIUM AND VILANTEROL ELLIPTA — Supplemental Application (Prasco Laboratories)

  FDA documents a supplemental application from Prasco Laboratories for umeclidinium bromide and vilanterol trifenatate Ellipta, a generic ver…

• FDA approval · 2019-05-29
  FDA Approved: STRIVERDI RESPIMAT — Supplemental Application (Boehringer Ingelheim Pharmaceuticals, Inc.)

  FDA approved a supplemental application for STRIVERDI RESPIMAT (olodaterol respimat inhalation spray) submitted by Boehringer Ingelheim Phar…

• FDA approval · 2019-05-29
  FDA Approved: STIOLTO RESPIMAT — Supplemental Application (Boehringer Ingelheim Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for STIOLTO RESPIMAT (tiotropium bromide and olodaterol) submitted by Boehringer Ingelheim Pharm…

• FDA approval · 2019-05-29
  FDA Approved: BEVESPI AEROSPHERE — Supplemental Application (AstraZeneca Pharmaceuticals LP)

  FDA approved a supplemental application for Bevespi Aerosphere (glycopyrrolate and formoterol fumarate) by AstraZeneca Pharmaceuticals LP.

• FDA approval · 2019-05-21
  FDA Approved: YUPELRI — Supplemental Application (Viatris Specialty LLC)

  The FDA approved Viatris Specialty LLC's supplemental application for YUPELRI (revefenacin), expanding its approved labeling.

• FDA approval · 2019-05-15
  FDA Approved: TRELEGY ELLIPTA — Supplemental Application (GlaxoSmithKline LLC)

  The FDA approved a supplemental application for TRELEGY ELLIPTA (fluticasone furoate/umeclidinium/vilanterol) from GlaxoSmithKline LLC, with…

• FDA approval · 2019-03-29
  FDA Approved: DUAKLIR PRESSAIR — Original Application (Covis Pharma US, Inc)

  FDA approved Duaklir Pressair as an original-application fixed-dose inhaled therapy combining aclidinium bromide and formoterol fumarate for…

• FDA approval · 2019-03-29
  FDA Approved: TUDORZA PRESSAIR — Supplemental Application (Covis Pharma US, Inc)

  The FDA approved a supplemental application for Tudorza Pressair (aclidinium bromide) from Covis Pharma US, Inc.

• FDA approval · 2019-03-22
  FDA Approved: ROFLUMILAST — Original Application (Micro Labs Limited)

  FDA approves Micro Labs Limited's generic roflumilast (original ANDA) for chronic obstructive pulmonary disease.

• FDA approval · 2019-03-15
  FDA Approved: ALBUTEROL — Original Application (Nivagen Pharmaceuticals Inc)

  FDA approves the original ANDA for albuterol sulfate (albuterol) from Nivagen Pharmaceuticals Inc, making a generic albuterol product availa…

• FDA approval · 2019-02-25
  FDA Approved: ALBUTEROL SULFATE HFA — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a supplemental application for Teva's Albuterol Sulfate HFA inhalation product, authorizing changes under the approved NDA/appr…

• FDA approval · 2019-02-21
  FDA Approved: PREDNISONE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  The FDA approved a supplemental application for prednisone from Mylan Pharmaceuticals, indicating approval of an existing generic product's …

• FDA approval · 2019-02-14
  FDA Approved: SPIRIVA RESPIMAT — Supplemental Application (Boehringer Ingelheim Pharmaceuticals, Inc.)

  FDA approved a supplemental application for Spiriva Respimat tiotropium inhalation spray from Boehringer Ingelheim Pharmaceuticals.

• FDA approval · 2019-01-30
  FDA Approved: WIXELA INHUB — Original Application (Mylan Pharmaceuticals Inc.)

  FDA approves Wixela Inhub as the generic inhaled fixed-dose combination of fluticasone propionate and salmeterol, manufactured by Mylan, und…

• FDA approval · 2019-01-09
  FDA Approved: PROAIR DIGIHALER — Supplemental Application (Teva Respiratory, LLC)

  The FDA approved a supplemental application for PROAIR DIGIHALER (albuterol sulfate) submitted by Teva Respiratory, LLC. This action updates…

• FDA approval · 2019-01-07
  FDA Approved: ADVAIR HFA — Supplemental Application (GlaxoSmithKline LLC)

  The FDA approved a supplemental application for Advair HFA (fluticasone propionate and salmeterol xinafoate) submitted by GlaxoSmithKline LL…

• FDA approval · 2019-01-07
  FDA Approved: FLUTICASONE PROPIONATE DISKUS — Supplemental Application (Prasco Laboratories)

  FDA approved a supplemental application for Fluticasone Propionate Diskus (NDA020833) submitted by Prasco Laboratories. The approval confirm…

• FDA approval · 2019-01-07
  FDA Approved: BREO ELLIPTA — Supplemental Application (GlaxoSmithKline LLC)

  FDA approved a supplemental application for BREO ELLIPTA (FLUTICASONE FUROATE AND VILANTEROL TRIFENATATE) from GlaxoSmithKline LLC, resultin…

• FDA approval · 2019-01-07
  FDA Approved: TRELEGY ELLIPTA — Supplemental Application (GlaxoSmithKline LLC)

  The FDA approved a supplemental application for TRELEGY ELLIPTA submitted by GlaxoSmithKline LLC.