Asthma

• FDA approval · 2019-11-15
  FDA Approved: PREDNISONE — Original Application (ANI Pharmaceuticals, Inc.)

  The FDA approves ANI Pharmaceuticals' original (generic) application for prednisone, enabling a generic prednisone product to be marketed.

• FDA approval · 2019-11-08
  FDA Approved: PROVOCHOLINE — Supplemental Application (Methapharm Inc.)

  The FDA approves a supplemental application for ProvoCholine (methacholine chloride inhalation solution) submitted by Methapharm Inc., allow…

• FDA approval · 2019-11-08
  FDA Approved: MONTELUKAST — Supplemental Application (BluePoint Laboratories)

  FDA approved a supplemental application for Montelukast submitted by BluePoint Laboratories. The action pertains to an additional indication…

• FDA approval · 2019-11-08
  FDA Approved: MONTELUKAST SODIUM — Supplemental Application (Ajanta Pharma USA Inc.)

  FDA approved Ajanta Pharma USA Inc.'s supplemental application for montelukast sodium.

• FDA approval · 2019-11-08
  FDA Approved: MONTELUKAST SODIUM — Supplemental Application (Ajanta Pharma USA Inc.)

  The FDA approved Ajanta Pharma USA Inc.'s supplemental application for Montelukast Sodium, enabling the generic montelukast product (ANDA 20…

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• FDA approval · 2019-11-08
  FDA Approved: MONTELUKAST SODIUM — Supplemental Application (Ajanta Pharma USA Inc.)

  FDA approves Ajanta Pharma USA Inc.'s supplemental application for Montelukast Sodium, updating regulatory status for the product.

• FDA approval · 2019-11-07
  FDA Approved: MONTELUKAST SODIUM — Supplemental Application (Accord Healthcare Inc.)

  FDA approved Accord Healthcare's supplemental application for montelukast sodium under ANDA202717, resulting in an updated approved product.…

• FDA approval · 2019-11-05
  FDA Approved: MONTELUKAST SODIUM — Supplemental Application (Rising Pharma Holdings, Inc.)

  FDA approved a supplemental ANDA for montelukast sodium from Rising Pharma Holdings, enabling the marketing of a generic montelukast sodium …

• FDA approval · 2019-11-05
  FDA Approved: MONTELUKAST SODIUM — Supplemental Application (Rising Pharma Holdings, Inc.)

  FDA approved a supplemental application for Montelukast Sodium from Rising Pharma Holdings, Inc., enabling a generic product entry. This dec…

• FDA approval · 2019-10-29
  FDA Approved: BUDESONIDE — Supplemental Application (Rite Aid Corporation)

  FDA approved a supplemental application for Budesonide by Rite Aid Corporation, expanding or modifying the approval of this generic product.

• FDA approval · 2019-09-06
  FDA Approved: PULMICORT FLEXHALER — Supplemental Application (H2-Pharma LLC)

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

• FDA approval · 2019-09-06
  FDA Approved: ALBUTEROL SULFATE — Original Application (QUAGEN PHARMACEUTICALS LLC)

  FDA approves QUAGEN PHARMACEUTICALS LLC's ALBUTEROL SULFATE original application, granting a generic albuterol sulfate product for relief of…

• FDA approval · 2019-08-12
  FDA Approved: DULERA — Supplemental Application (Organon LLC)

  FDA approved a supplemental application for DULERA (mometasone furoate/formoterol fumarate dihydrate) from Organon LLC.

• FDA approval · 2019-08-12
  FDA Approved: ASMANEX HFA — Supplemental Application (Organon LLC)

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

• FDA approval · 2019-08-09
  FDA Approved: SINGULAIR — Supplemental Application (Organon LLC)

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

• FDA approval · 2019-08-09
  FDA Approved: SINGULAIR — Supplemental Application (Organon LLC)

  FDA approved a supplemental application for Singulair (montelukast) by Organon LLC, marking an additional regulatory action for the product.

• FDA approval · 2019-08-09
  FDA Approved: SINGULAIR — Supplemental Application (Organon LLC)

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

• FDA approval · 2019-08-05
  FDA Approved: ZILEUTON — Supplemental Application (Rising Pharma Holdings, Inc.)

  FDA approved a supplemental application for Zileuton (generic) by Rising Pharma Holdings, Inc. under ANDA204929.

• FDA approval · 2019-07-22
  FDA Approved: SEREVENT DISKUS — Supplemental Application (GlaxoSmithKline LLC)

  The FDA approved a supplemental application for SEREVENT DISKUS (salmeterol xinafoate) submitted by GlaxoSmithKline LLC.

• FDA approval · 2019-06-06
  FDA Approved: NUCALA — Original Application (GlaxoSmithKline LLC)

  FDA approves the original application for NUCALA (mepolizumab) by GlaxoSmithKline, for add-on maintenance treatment in patients with severe …

• FDA approval · 2019-05-29
  FDA Approved: FORMOTEROL FUMARATE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approved a supplemental application for Formoterol Fumarate from Mylan Pharmaceuticals, indicating approval of a supplemental NDA for th…

• FDA approval · 2019-03-15
  FDA Approved: ALBUTEROL — Original Application (Nivagen Pharmaceuticals Inc)

  FDA approves the original ANDA for albuterol sulfate (albuterol) from Nivagen Pharmaceuticals Inc, making a generic albuterol product availa…

• EMA approval · 2019-03-01
  New add-on treatment for patients with severe asthma

  EMA announces a new add-on treatment for patients with severe asthma, indicating a fresh therapeutic option may be available in the European…

• FDA approval · 2019-02-25
  FDA Approved: ALBUTEROL SULFATE HFA — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a supplemental application for Teva's Albuterol Sulfate HFA inhalation product, authorizing changes under the approved NDA/appr…

• FDA approval · 2019-02-21
  FDA Approved: PREDNISONE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  The FDA approved a supplemental application for prednisone from Mylan Pharmaceuticals, indicating approval of an existing generic product's …