Asthma

• FDA approval · 2017-04-24
  FDA Approved: MONTELUKAST SODIUM — Original Application (Rising Pharma Holdings, Inc.)

  The FDA approved a generic Montelukast Sodium product from Rising Pharma Holdings, Inc. under an Original Application (ANDA209012). It provi…

• FDA approval · 2017-03-17
  FDA Approved: ZILEUTON — Original Application (Rising Pharma Holdings, Inc.)

  FDA approved Rising Pharma Holdings, Inc.'s original ANDA for zileuton, enabling a generic zileuton product for the treatment of asthma. Thi…

• FDA approval · 2017-02-28
  FDA Approved: ADVAIR DISKUS — Supplemental Application (GlaxoSmithKline LLC)

  FDA granted a supplemental approval for Advair Diskus (fluticasone propionate and salmeterol) by GlaxoSmithKline LLC.

• FDA approval · 2017-02-28
  FDA Approved: ADVAIR HFA — Supplemental Application (GlaxoSmithKline LLC)

  The FDA approved a supplemental application for ADVAIR HFA (fluticasone propionate and salmeterol xinafoate) from GlaxoSmithKline LLC.

• FDA approval · 2017-02-27
  FDA Approved: XOPENEX HFA — Supplemental Application (Lupin Pharmaceuticals, Inc.)

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

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• FDA approval · 2017-02-16
  FDA Approved: FLUTICASONE PROPIONATE — Supplemental Application (Padagis Israel Pharmaceuticals Ltd)

  FDA approved a supplemental application for Fluticasone Propionate submitted by Padagis Israel Pharmaceuticals Ltd.

• FDA approval · 2017-01-31
  FDA Approved: LEVALBUTEROL — Original Application (Aurobindo Pharma Limited)

  The FDA approved an original ANDA for Levalbuterol from Aurobindo Pharma Limited, providing a generic option for this bronchodilator.

• FDA approval · 2017-01-27
  FDA Approved: FLUTICASONE PROPIONATE AND SALMETEROL — Original Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved Teva's Fluticasone Propionate and Salmeterol under an Original Application (NDA208799), a fixed-dose inhaled corticosteroid/lon…

• FDA approval · 2017-01-27
  FDA Approved: BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE — Supplemental Application (AstraZeneca Pharmaceuticals LP)

  FDA approved a supplemental application for budesonide and formoterol fumarate dihydrate to update the product labeling for AstraZeneca's in…

• FDA approval · 2017-01-03
  FDA Approved: IPRATROPIUM BROMIDE — Original Application (Sun Pharmaceutical Industries, Inc.)

  The FDA approved Sun Pharmaceutical's ipratropium bromide as an original generic drug (ANDA approval).

• FDA approval · 2016-12-30
  FDA Approved: LEVALBUTEROL — Original Application (Aurobindo Pharma Limited)

  FDA approved the original ANDA for levalbuterol manufactured by Aurobindo Pharma Limited.

• FDA approval · 2016-12-16
  FDA Approved: THEOPHYLLINE — Original Application (PAI Holdings, LLC dba PAI Pharma)

  FDA approves the original generic application for theophylline from PAI Holdings/PAI Pharma, authorizing the sale of a generic theophylline …

• FDA approval · 2016-12-13
  FDA Approved: SINGULAIR — Supplemental Application (Organon LLC)

  The FDA approved a supplemental application for Singulair (montelukast sodium) filed by Organon LLC.

• FDA approval · 2016-10-05
  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 · 2016-10-05
  FDA Approved: FLUTICASONE PROPIONATE DISKUS — Supplemental Application (Prasco Laboratories)

  The FDA approved a supplemental application for Fluticasone Propionate Diskus submitted by Prasco Laboratories, authorizing the marketing of…

• FDA approval · 2016-09-30
  FDA Approved: SEREVENT DISKUS — Supplemental Application (GlaxoSmithKline LLC)

  FDA approved a supplemental application for SEREVENT DISKUS (salmeterol xinafoate) from GlaxoSmithKline LLC, indicating an approved change t…

• FDA approval · 2016-08-29
  FDA Approved: PROVOCHOLINE — Supplemental Application (Methapharm Inc.)

  FDA approved a supplemental application for PROVOCHOLINE (methacholine chloride) from Methapharm Inc. The action confirms regulatory approva…

• FDA approval · 2016-07-28
  FDA Approved: FLUTICASONE PROPIONATE HFA — Supplemental Application (Prasco Laboratories)

  FDA approved a supplemental application for Fluticasone Propionate HFA by Prasco Laboratories, adding a generic inhaled corticosteroid produ…

• FDA approval · 2016-07-28
  FDA Approved: FLUTICASONE PROPIONATE DISKUS — Supplemental Application (Prasco Laboratories)

  FDA approved a supplemental application for Fluticasone Propionate Diskus, with Prasco Laboratories as the applicant.

• FDA approval · 2016-07-12
  FDA Approved: DULERA — Supplemental Application (Organon LLC)

  The FDA approved a supplemental application for Dulera (mometasone furoate/formoterol fumarate dihydrate) submitted by Organon LLC.

• FDA approval · 2016-06-23
  FDA Approved: MONTELUKAST — Supplemental Application (BluePoint Laboratories)

  The FDA approved a supplemental application for Montelukast from BluePoint Laboratories.

• FDA approval · 2016-06-17
  FDA Approved: PULMICORT FLEXHALER — Supplemental Application (H2-Pharma LLC)

  FDA approved a supplemental application for Pulmicort Flexhaler (budesonide) from H2-Pharma LLC.

• FDA approval · 2016-06-02
  FDA Approved: MONTELUKAST SODIUM — Supplemental Application (Lannett Company, Inc.)

  The FDA approved a supplemental application for Montelukast Sodium from Lannett Company, Inc., supporting a generic montelukast product.

• FDA approval · 2016-05-20
  FDA Approved: ALBUTEROL SULFATE HFA — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a supplemental application for Teva's Albuterol Sulfate HFA inhalation product.

• FDA approval · 2016-05-12
  FDA Approved: DULERA — Supplemental Application (Organon LLC)

  The FDA approved a supplemental application for DULERA (mometasone furoate and formoterol fumarate dihydrate) submitted by Organon LLC.