Asthma

• FDA approval · 2016-05-11
  FDA Approved: PROAIR DIGIHALER — Supplemental Application (Teva Respiratory, LLC)

  The FDA approved Teva Respiratory's supplemental application for PROAIR DIGIHALER (albuterol sulfate), authorizing the supplemental action r…

• FDA approval · 2016-04-29
  FDA Approved: ATROVENT HFA — Supplemental Application (Boehringer Ingelheim Pharmaceuticals, Inc.)

  FDA approves a supplemental application for ATROVENT HFA (ipratropium bromide) from Boehringer Ingelheim Pharmaceuticals, Inc. The approval …

• FDA approval · 2016-04-29
  FDA Approved: ADVAIR DISKUS — Supplemental Application (GlaxoSmithKline LLC)

  The FDA approved a supplemental application for Advair Diskus (fluticasone propionate and salmeterol) from GlaxoSmithKline LLC.

• FDA approval · 2016-04-29
  FDA Approved: BUDESONIDE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved Teva Pharmaceuticals USA, Inc.'s supplemental application for budesonide. The action reflects changes to the product's labeling…

• FDA approval · 2016-04-28
  FDA Approved: PROAIR DIGIHALER — Supplemental Application (Teva Respiratory, LLC)

  The FDA approved a supplemental application for PROAIR DIGIHALER (albuterol sulfate) from Teva Respiratory, LLC.

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• FDA approval · 2016-04-19
  FDA Approved: MONTELUKAST SODIUM — Supplemental Application (Unichem Pharmaceuticals (USA), Inc.)

  FDA approved a supplemental application for Montelukast Sodium from Unichem Pharmaceuticals (USA), Inc., under the ANDA.

• FDA approval · 2016-03-29
  FDA Approved: ZAFIRLUKAST — Supplemental Application (Strides Pharma Science Limited)

  FDA approved a supplemental application for Zafirlukast from Strides Pharma Science Limited. The action concerns the approval of a supplemen…

• FDA approval · 2016-03-24
  FDA Approved: LEVALBUTEROL — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved Teva's supplemental application for levalbuterol, confirming approval of the generic product under an ANDA and enabling continu…

• FDA approval · 2016-03-23
  FDA Approved: CINQAIR — Original Application (Teva Respiratory, LLC)

  FDA approved CINQAIR (reslizumab) as add-on maintenance therapy for adults with severe asthma with an eosinophilic phenotype.

• FDA approval · 2016-03-22
  FDA Approved: LEVALBUTEROL — Original Application (Mylan Pharmaceuticals Inc.)

  FDA approves Mylan's original ANDA for levalbuterol hydrochloride, a generic inhaled bronchodilator indicated for reversible obstructive air…

• FDA approval · 2016-03-08
  FDA Approved: BUDESONIDE — Original Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a generic budesonide product under an Original Application (ANDA 204548) for Teva Pharmaceuticals USA, Inc. This marks the appr…

• FDA approval · 2016-03-03
  FDA Approved: ALBUTEROL SULFATE — Supplemental Application (Sandoz Inc)

  The FDA approved a supplemental application for albuterol sulfate from Sandoz Inc, updating the product labeling.

• FDA approval · 2016-03-01
  FDA Approved: MONTELUKAST SODIUM — Supplemental Application (Torrent Pharmaceuticals Limited)

  FDA approved Torrent Pharmaceuticals Limited's supplemental application for Montelukast Sodium (montelukast) under an ANDA.

• FDA approval · 2016-01-22
  FDA Approved: XOPENEX HFA — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  The FDA approved Lupin Pharmaceuticals' supplemental application for XOPENEX HFA (levalbuterol tartrate).

• FDA approval · 2016-01-12
  FDA Approved: MONTELUKAST SODIUM — Original Application (Westminster Pharmaceuticals, LLC)

  FDA approved Westminster Pharmaceuticals, LLC's original application for Montelukast SODIUM, establishing a generic montelukast sodium produ…

• FDA approval · 2016-01-06
  FDA Approved: FLUTICASONE PROPIONATE HFA — Supplemental Application (Prasco Laboratories)

  The FDA approved a supplemental application for Fluticasone Propionate HFA submitted by Prasco Laboratories.

• FDA approval · 2016-01-04
  FDA Approved: MONTELUKAST SODIUM — Supplemental Application (Torrent Pharmaceuticals Limited)

  FDA approved a supplemental application for Montelukast Sodium from Torrent Pharmaceuticals Limited. The entry indicates a supplemental appr…

• FDA approval · 2016-01-04
  FDA Approved: MONTELUKAST SODIUM — Supplemental Application (Torrent Pharmaceuticals Limited)

  The FDA approves a supplemental application for Montelukast Sodium from Torrent Pharmaceuticals Limited under ANDA 201515.

• FDA approval · 2015-12-11
  FDA Approved: PROAIR DIGIHALER — Supplemental Application (Teva Respiratory, LLC)

  FDA approved a supplemental application for PROAIR DIGIHALER (albuterol sulfate) from Teva Respiratory, LLC, adding the DigiHALER device var…

• FDA approval · 2015-12-08
  FDA Approved: MONTELUKAST SODIUM — Supplemental Application (Rising Pharma Holdings, Inc.)

  FDA approved a supplemental application for Montelukast sodium from Rising Pharma Holdings, Inc. under an ANDA, marking approval of a supple…

• FDA approval · 2015-11-30
  FDA Approved: BUDESONIDE — Supplemental Application (Chartwell RX, LLC)

  The FDA approved a supplemental application for Budesonide from Chartwell RX, LLC, authorizing a change to an existing generic product.

• FDA approval · 2015-11-20
  FDA Approved: BUDESONIDE — Supplemental Application (Rite Aid Corporation)

  FDA approved a supplemental application for Budesonide filed by Rite Aid Corporation (ANDA078949), confirming an updated approval for this g…

• FDA approval · 2015-11-18
  FDA Approved: IPRATROPIUM BROMIDE — Supplemental Application (Apotex Corp.)

  FDA approved Apotex Corp.'s supplemental application for ipratropium bromide (generic) under ANDA 076155. The approval concerns a supplement…

• FDA approval · 2015-10-21
  FDA Approved: BREO ELLIPTA — Supplemental Application (GlaxoSmithKline LLC)

  FDA approved a supplemental application for Breo Ellipta (fluticasone furoate and vilanterol trifenenate) submitted by GlaxoSmithKline.

• FDA approval · 2015-10-08
  FDA Approved: MONTELUKAST SODIUM — Original Application (Unichem Pharmaceuticals (USA), Inc.)

  FDA approved Unichem Pharmaceuticals (USA), Inc.'s Montelukast Sodium generic under Original Application (ANDA204290), authorizing its marke…