Asthma

• FDA approval · 2023-06-26
  FDA Approved: MONTELUKAST SODIUM — Supplemental Application (Lannett Company, Inc.)

  FDA approves a supplemental application for montelukast sodium from Lannett Company, Inc., under ANDA200405, authorizing an updated generic …

• FDA approval · 2023-06-23
  FDA Approved: ALBUTEROL SULFATE — Supplemental Application (Luoxin Aurovitas Pharma (Chengdu) Co., Ltd.)

  FDA approved a supplemental application for ALBUTEROL SULFATE from Luoxin Aurovitas Pharma (Chengdu) Co., Ltd. under an ANDA for a generic p…

• FDA approval · 2023-06-08
  FDA Approved: MONTELUKAST SODIUM — Supplemental Application (Camber Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for Montelukast Sodium submitted by Camber Pharmaceuticals, Inc., under the approved ANDA.

• FDA approval · 2023-06-07
  FDA Approved: MONTELUKAST — Supplemental Application (BluePoint Laboratories)

  FDA approved a supplemental application for Montelukast submitted by BluePoint Laboratories.

• FDA approval · 2023-05-28
  FDA Approved: ALBUTEROL SULFATE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  FDA approves a supplemental application for albuterol sulfate from Sun Pharmaceutical Industries, updating the status of this generic produc…

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• FDA approval · 2023-05-26
  FDA Approved: TEZSPIRE — Supplemental Application (Amgen Inc)

  FDA approved a supplemental application for Tezspire (tezepelumab-ekko) from Amgen, updating the product label.

• FDA approval · 2023-05-12
  FDA Approved: BREO ELLIPTA — Supplemental Application (GlaxoSmithKline LLC)

  FDA approved a supplemental application for BREO ELLIPTA submitted by GlaxoSmithKline. The approval pertains to changes to the product's lab…

• FDA approval · 2023-05-08
  FDA Approved: ALBUTEROL SULFATE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  The FDA approved a supplemental application for albuterol sulfate submitted by Mylan Pharmaceuticals Inc. under ANDA214531. This action adds…

• FDA approval · 2023-04-26
  FDA Approved: THEOPHYLLINE — Original Application (Bionpharma Inc.,)

  FDA approves Bionpharma Inc.’s Theophylline generic under an Original Application (ANDA). The product is approved for use in asthma and chro…

• FDA approval · 2023-04-12
  FDA Approved: LEVALBUTEROL — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approved a supplemental application for levalbuterol by Mylan Pharmaceuticals, approving a change to the product under ANDA 078309.

• FDA approval · 2023-04-12
  FDA Approved: BUDESONIDE — Original Application (Padagis Israel Pharmaceuticals Ltd)

  FDA approved the original application for Budesonide from Padagis Israel Pharmaceuticals Ltd, granting a generic version of budesonide. The …

• FDA approval · 2023-03-22
  FDA Approved: FORMOTEROL FUMARATE — Original Application (Lifestar Pharma LLC)

  FDA approves the original application for Formoterol fumarate dihydrate supplied by Lifestar Pharma LLC. This generic product is approved fo…

• FDA approval · 2023-03-20
  FDA Approved: THEOPHYLLINE — Original Application (Amneal Pharmaceuticals NY LLC)

  FDA approved Amneal's Theophylline (generic) under an Original Application (ANDA 216276). Theophylline is indicated for relief of bronchospa…

• FDA approval · 2023-03-17
  FDA Approved: XOLAIR — Supplemental Application (Genentech, Inc.)

  FDA approved a supplemental application for XOLAIR (omalizumab) submitted by Genentech, Inc., representing an additional regulatory action f…

• FDA approval · 2023-03-08
  FDA Approved: LEVALBUTEROL — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approved a supplemental application for levalbuterol products from Mylan Pharmaceuticals Inc. under the ANDA program. This action confir…

• FDA approval · 2023-03-01
  FDA Approved: FLUTICASONE FUROATE ELLIPTA — Supplemental Application (Prasco Laboratories)

  FDA approved a supplemental application for Fluticasone Furoate Ellipta from Prasco Laboratories.

• FDA approval · 2023-02-16
  FDA Approved: ALVESCO — Supplemental Application (Covis Pharma US, Inc)

  The FDA approved a supplemental application for ALVESCO (ciclesonide) submitted by Covis Pharma US, Inc. This action represents regulatory a…

• FDA approval · 2023-02-08
  FDA Approved: FLUTICASONE PROPIONATE AND SALMETEROL — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  The FDA approved a supplemental application for a generic inhaled fixed-dose combination of fluticasone propionate and salmeterol by Hikma P…

• FDA approval · 2023-02-01
  FDA Approved: TEZSPIRE — Supplemental Application (Amgen Inc)

  The FDA approved a supplemental application for TEZSPIRE (tezepelumab-ekko) from Amgen, indicating an update related to its labeling or indi…

• FDA approval · 2023-01-30
  FDA Approved: THEOPHYLLINE — Original Application (Leading Pharma, LLC)

  FDA approved Leading Pharma, LLC's original ANDA for theophylline, authorizing a generic version of theophylline. The approval supports its …

• FDA approval · 2023-01-10
  FDA Approved: AIRSUPRA — Original Application (AstraZeneca Pharmaceuticals LP)

  FDA approved AirSupra, an original-application inhaled therapy combining albuterol sulfate and budesonide for asthma, developed by AstraZene…

• FDA approval · 2022-10-12
  FDA Approved: THEOPHYLLINE — Original Application (Teva Pharmaceuticals, Inc.)

  The FDA approved an original application for a generic Theophylline product from Teva Pharmaceuticals.

• FDA approval · 2022-10-11
  FDA Approved: ZILEUTON — Original Application (NorthStar RxLLC)

  The FDA approved the original application for zileuton, with NorthStar RxLLC listed as the applicant.

• FDA approval · 2022-08-16
  FDA Approved: IPRATROPIUM BROMIDE — Original Application (Amneal Pharmaceuticals NY LLC)

  FDA approved the original ANDA for ipratropium bromide as a generic inhalation product from Amneal Pharmaceuticals NY LLC.

• FDA approval · 2022-06-16
  FDA Approved: FLUNISOLIDE — Original Application (Ingenus Pharmaceuticals, LLC)

  FDA approved the original application for flunisolide from Ingenus Pharmaceuticals, confirming the generic product's approval for its indica…