Asthma

• FDA approval · 2020-09-10
  FDA Approved: ZAFIRLUKAST — Original Application (Camber Pharmaceuticals, Inc.)

  The FDA approved Camber Pharmaceuticals' generic Zafirlukast, marking the first approval of this generic product for asthma.

• FDA approval · 2020-09-04
  FDA Approved: MONTELUKAST — Supplemental Application (Sandoz Inc)

  FDA approved a supplemental application from Sandoz Inc for montelukast under the ANDA, confirming changes to the generic product's labeling…

• FDA approval · 2020-09-04
  FDA Approved: MONTELUKAST SODIUM — Original Application (Amneal Pharmaceuticals LLC)

  FDA approved Amneal Pharmaceuticals' Montelukast Sodium as a generic version of montelukast for the prevention and maintenance treatment of …

• FDA approval · 2020-09-02
  FDA Approved: PREDNISONE — Original Application (Strides Pharma Science Limited)

  FDA approval of a generic prednisone (PREDNISONE) Original Application by Strides Pharma Science Limited.

• FDA approval · 2020-08-24
  FDA Approved: ALBUTEROL SULFATE — Original Application (Lupin Pharmaceuticals, Inc.)

  FDA approved Lupin Pharmaceuticals' original ANDA for albuterol sulfate, authorizing the marketing of a generic albuterol sulfate product.

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• FDA approval · 2020-08-14
  FDA Approved: MONTELUKAST SODIUM — Supplemental Application (Rising Pharma Holdings, Inc.)

  The FDA approved a supplemental application for Montelukast Sodium from Rising Pharma Holdings, Inc. This action authorizes changes to the p…

• FDA approval · 2020-07-15
  FDA Approved: BUDESONIDE — Supplemental Application (Padagis US LLC)

  FDA approved a supplemental application for budesonide submitted by Padagis US LLC. The approval updates the labeling for budesonide under t…

• FDA approval · 2020-07-09
  FDA Approved: IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE — Original Application (Aurobindo Pharma Limited)

  FDA approved Aurobindo Pharma's original ANDA for a generic combination of ipratropium bromide and albuterol sulfate.

• FDA approval · 2020-06-19
  FDA Approved: TERBUTALINE SULFATE — Original Application (Upsher-Smith Laboratories, LLC)

  FDA approval of the original application for Terbutaline Sulfate from Upsher-Smith Laboratories, a generic bronchodilator.

• FDA approval · 2020-06-01
  FDA Approved: KETOTIFEN FUMARATE — Original Application (Unichem Pharmaceuticals (USA), Inc.)

  FDA approved Unichem Pharmaceuticals (USA), Inc.'s original application for ketotifen fumarate as a generic antihistamine product. This mark…

• FDA approval · 2020-05-14
  FDA Approved: ALBUTEROL — Original Application (Aurobindo Pharma Limited)

  FDA approved the original application for ALBUTEROL (albuterol) inhalation product by Aurobindo Pharma Limited.

• EMA approval · 2020-04-30
  First triple combination therapy for asthma with optional electronic sensor

  The European Medicines Agency announces the first triple combination therapy for asthma with an optional electronic sensor to monitor adhere…

• FDA approval · 2020-04-20
  FDA Approved: ALBUTEROL SULFATE — Original Application (Luoxin Aurovitas Pharma (Chengdu) Co., Ltd.)

  The FDA approved an original application for a generic albuterol sulfate product by Luoxin Aurovitas Pharma (Chengdu) Co., Ltd., authorizing…

• FDA approval · 2020-04-08
  FDA Approved: ALBUTEROL SULFATE — Original Application (American Health Packaging)

  FDA approved the original application for albuterol sulfate, a generic product manufactured by American Health Packaging, expanding access t…

• FDA approval · 2020-02-24
  FDA Approved: ALBUTEROL SULFATE — Original Application (Padagis Israel Pharmaceuticals Ltd)

  FDA approved Padagis Israel Pharmaceuticals Ltd's original ANDA for albuterol sulfate. The product is a generic inhaled bronchodilator indic…

• FDA approval · 2020-02-21
  FDA Approved: FLUTICASONE PROPIONATE AND SALMETEROL — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a supplemental application for Fluticasone Propionate and Salmeterol from Teva, updating the product's labeling (e.g., indicati…

• FDA approval · 2020-02-18
  FDA Approved: MONTELUKAST SODIUM — Original Application (Aurobindo Pharma Limited)

  FDA approved Aurobindo Pharma Limited's original application for Montelukast Sodium, a generic montelukast product.

• FDA approval · 2020-02-07
  FDA Approved: LEVALBUTEROL — Supplemental Application (Aurobindo Pharma Limited)

  The FDA approved a supplemental application for Levalbuterol submitted by Aurobindo Pharma Limited.

• FDA approval · 2020-02-06
  FDA Approved: LEVALBUTEROL — Supplemental Application (Aurobindo Pharma Limited)

  The FDA approved a supplemental application for levalbuterol from Aurobindo Pharma Limited.

• FDA approval · 2019-12-20
  FDA Approved: LEVALBUTEROL INHALATION SOLUTION — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved a supplemental ANDA for Levalbuterol Inhalation Solution from Sun Pharmaceutical Industries, granting generic approval for this…

• FDA approval · 2019-12-19
  FDA Approved: ASMANEX — Supplemental Application (Organon LLC)

  The FDA approved a supplemental application for ASMANEX (mometasone furoate) submitted by Organon LLC.

• FDA approval · 2019-12-16
  FDA Approved: VENTOLIN HFA — Supplemental Application (GlaxoSmithKline LLC)

  The FDA approved GlaxoSmithKline LLC's supplemental application for Ventolin HFA (albuterol sulfate) under NDA 020983, resulting in a regula…

• FDA approval · 2019-12-16
  FDA Approved: ZILEUTON — Original Application (Strides Pharma Science Limited)

  FDA approves Strides Pharma Science Limited's ZILEUTON under an original ANDA, providing a generic zileuton for the prophylaxis and chronic …

• FDA approval · 2019-12-06
  FDA Approved: MONTELUKAST SODIUM — Supplemental Application (Amneal Pharmaceuticals LLC)

  FDA approved Amneal Pharmaceuticals LLC's supplemental application for montelukast sodium (generic montelukast).

• FDA approval · 2019-11-25
  FDA Approved: FLUTICASONE PROPIONATE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for Fluticasone Propionate from Hikma Pharmaceuticals USA Inc., under the ANDA program.