Asthma

• 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 · 2019-01-29
  FDA Approved: ADRENALIN — Supplemental Application (Par Health USA, LLC)

  The FDA approved a supplemental application for ADRENALIN (epinephrine) filed by Par Health USA, LLC.

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

  FDA approved a supplemental application for CINQAIR (reslizumab) submitted by Teva Respiratory, LLC.

• 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…

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• 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: FLUTICASONE FUROATE ELLIPTA — Supplemental Application (Prasco Laboratories)

  The FDA approved a supplemental application for Fluticasone Furoate Ellipta submitted by Prasco Laboratories.

• FDA approval · 2018-12-21
  FDA Approved: SINGULAIR — Supplemental Application (Organon LLC)

  The FDA approved a supplemental application to the Singulair (montelukast) NDA submitted by Organon LLC.

• FDA approval · 2018-12-21
  FDA Approved: SEREVENT DISKUS — Supplemental Application (GlaxoSmithKline LLC)

  FDA approved a supplemental application for SEREVENT Diskus (salmeterol xinafoate) from GlaxoSmithKline.

• FDA approval · 2018-12-21
  FDA Approved: SINGULAIR — Supplemental Application (Organon LLC)

  FDA approved a supplemental application for Singulair (montelukast) submitted by Organon LLC.

• FDA approval · 2018-11-19
  FDA Tentative Approval: QVAR REDIHALER — Supplemental Application (Teva Respiratory, LLC)

  FDA issued tentative approval for Teva Respiratory's supplemental NDA for QVAR REDIHALER (beclomethasone dipropionate HFA). The inhaled cort…

• FDA approval · 2018-11-09
  FDA Approved: BUDESONIDE INHALATION — Original Application (Lupin Pharmaceuticals, Inc.)

  FDA approved Lupin Pharmaceuticals’ original application for budesonide inhalation, a generic inhaled corticosteroid for the maintenance tre…

• FDA approval · 2018-11-07
  FDA Approved: PRIMATENE MIST — Original Application (Armstrong Pharmaceuticals, Inc.)

  FDA approved Primatene Mist, an epinephrine inhalation product from Armstrong Pharmaceuticals, under an Original Application (NDA205920). Th…

• FDA approval · 2018-11-05
  FDA Approved: LEVALBUTEROL INHALATION SOLUTION — Original Application (Sun Pharmaceutical Industries, Inc.)

  FDA approves Sun Pharmaceutical's levalbuterol inhalation solution as an original generic application. It is indicated for relief of broncho…

• FDA approval · 2018-10-19
  FDA Approved: DUPIXENT — Supplemental Application (sanofi-aventis U.S. LLC)

  FDA approved a supplemental application for DUPIXENT (dupilumab) submitted by Sanofi-Aventis U.S. LLC.

• FDA approval · 2018-07-31
  FDA Approved: MONTELUKAST SODIUM — Original Application (Torrent Pharmaceuticals Limited)

  FDA approves Torrent Pharmaceuticals Limited's original ANDA for montelukast sodium (generic montelukast).

• FDA approval · 2018-07-30
  FDA Approved: MONTELUKAST — Supplemental Application (XLCare Pharmaceuticals Inc.)

  FDA approved a supplemental application for montelukast from XLCare Pharmaceuticals Inc. under ANDA 202843.

• FDA approval · 2018-07-26
  FDA Approved: MONTELUKAST — Supplemental Application (Sandoz Inc)

  The FDA approved a supplemental application for Montelukast from Sandoz Inc, authorizing the generic montelukast product under an ANDA.

• FDA approval · 2018-07-23
  FDA Approved: MONTELUKAST SODIUM — Supplemental Application (Rising Pharma Holdings, Inc.)

  FDA approved a supplemental application for Montelukast Sodium from Rising Pharma Holdings, Inc., enabling the marketing of the generic prod…

• FDA approval · 2018-07-23
  FDA Approved: MONTELUKAST SODIUM — Supplemental Application (Rising Pharma Holdings, Inc.)

  FDA approved a supplemental application for a generic Montelukast sodium product from Rising Pharma Holdings, Inc.

• FDA approval · 2018-07-23
  FDA Approved: MONTELUKAST SODIUM — Supplemental Application (Lannett Company, Inc.)

  FDA approved a supplemental application for Montelukast Sodium from Lannett Company, Inc., adding regulatory approval for an additional gene…

• FDA approval · 2018-07-03
  FDA Approved: BUDESONIDE — Original Application (Actavis Pharma, Inc.)

  FDA approved the original application for Budesonide from Actavis Pharma, Inc. (ANDA205457).

• FDA approval · 2018-07-02
  FDA Approved: MONTELUKAST SODIUM — Original Application (Unichem Pharmaceuticals (USA), Inc.)

  FDA approved the original ANDA for montelukast sodium from Unichem Pharmaceuticals (USA), Inc., establishing a generic version of this asthm…

• FDA approval · 2018-06-29
  FDA Approved: ALBUTEROL — Original Application (Rising Pharma Holdings, Inc.)

  FDA approved the original application for albuterol filed by Rising Pharma Holdings, Inc. under ANDA207046.