Asthma
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Sign up freeTop drugs studied for this disease
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FDA approval · 2013-06-19FDA Approved: ADVAIR DISKUS — Supplemental Application (GlaxoSmithKline LLC)
The FDA approved a supplemental application for Advair Diskus (fluticasone propionate and salmeterol) from GlaxoSmithKline.
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FDA approval · 2013-06-19FDA Approved: FLUTICASONE PROPIONATE DISKUS — Supplemental Application (Prasco Laboratories)
FDA approved a supplemental application for Fluticasone Propionate Diskus submitted by Prasco Laboratories.
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FDA approval · 2013-06-10FDA Approved: DULERA — Supplemental Application (Organon LLC)
FDA approved a supplemental application for DULERA (mometasone furoate and formoterol fumarate dihydrate) submitted by Organon LLC.
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FDA approval · 2013-05-15FDA Approved: ZAFIRLUKAST — Supplemental Application (Strides Pharma Science Limited)
FDA approved a supplemental application for Zafirlukast from Strides Pharma Science Limited. The action involves approval of a supplement to…
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FDA approval · 2013-05-10FDA Approved: LEVALBUTEROL — Supplemental Application (Mylan Pharmaceuticals Inc.)
FDA grants supplemental approval for a generic levalbuterol product from Mylan Pharmaceuticals, enabling market entry of a generic inhaled b…
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FDA approval · 2013-05-10FDA Approved: BREO ELLIPTA — Original Application (GlaxoSmithKline LLC)
FDA approved Breo Ellipta (fluticasone furoate and vilanterol) in its original application. It is an inhaled corticosteroid/long-acting beta…
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FDA approval · 2013-04-29FDA Approved: MONTELUKAST SODIUM — Supplemental Application (Accord Healthcare Inc.)
FDA approved Accord Healthcare Inc.'s supplemental application for Montelukast Sodium (ANDA 202717). This action confirms approval of a supp…
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FDA approval · 2013-04-26FDA Approved: LEVALBUTEROL — Original Application (Teva Pharmaceuticals USA, Inc.)
FDA approved Teva's LEVALBUTEROL as a generic inhalation solution (Original Application) for preventing and treating bronchospasm in reversi…
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FDA approval · 2013-04-10FDA Approved: PULMICORT RESPULES — Supplemental Application (AstraZeneca Pharmaceuticals LP)
The FDA approved a supplemental application for Pulmicort Respules (budesonide) from AstraZeneca Pharmaceuticals LP.
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FDA approval · 2013-04-04FDA Approved: CROMOLYN SODIUM — Original Application (Micro Labs Limited)
FDA approved Micro Labs Limited's original ANDA for cromolyn sodium.
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FDA approval · 2013-03-23FDA Approved: ALBUTEROL SULFATE HFA — Supplemental Application (Teva Pharmaceuticals USA, Inc.)
FDA approved a supplemental application for Albuterol Sulfate HFA (Teva Pharmaceuticals USA, Inc.), indicating regulatory action to modify t…
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EMA approval · 2013-03-22EMA Refused: Labazenit (Budesonide;salmeterol) — Laboratoires SMB S.A.
The EMA refused approval for Labazenit (budesonide; salmeterol) for asthma from Laboratoires SMB S.A., with a decision dated 22 March 2013.
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FDA approval · 2013-03-21FDA Approved: SINGULAIR — Supplemental Application (Organon LLC)
FDA approved a supplemental application for Singulair (montelukast sodium) submitted by Organon LLC, resulting in changes to the product lab…
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FDA approval · 2013-03-14FDA Approved: XOPENEX HFA — Supplemental Application (Lupin Pharmaceuticals, Inc.)
FDA approved a supplemental application for XOPENEX HFA (levalbuterol tartrate) from Lupin Pharmaceuticals, Inc.
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FDA approval · 2013-02-25FDA Approved: ALBUTEROL SULFATE — Supplemental Application (Sandoz Inc)
FDA approves a supplemental application for albuterol sulfate submitted by Sandoz Inc.
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FDA approval · 2013-02-19FDA Approved: LEVALBUTEROL — Supplemental Application (Mylan Pharmaceuticals Inc.)
The FDA approved a supplemental application from Mylan Pharmaceuticals Inc. for Levalbuterol, confirming the availability of a generic bronc…
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FDA approval · 2013-02-05FDA Approved: MONTELUKAST SODIUM — Supplemental Application (Dr.Reddy's Laboratories Limited)
The FDA approved a supplemental application for montelukast sodium submitted by Dr. Reddy's Laboratories Limited. The approval extends the r…
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FDA approval · 2013-02-05FDA Approved: MONTELUKAST SODIUM — Supplemental Application (Dr.Reddy's Laboratories Limited)
FDA approved a supplemental abbreviated new drug application for Montelukast Sodium from Dr. Reddy's Laboratories Limited, expanding generic…
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FDA approval · 2013-01-31FDA Approved: MONTELUKAST — Supplemental Application (Sandoz Inc)
FDA approved a supplemental application from Sandoz Inc. for montelukast, granting approval of changes to the generic montelukast product un…
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FDA approval · 2013-01-31FDA Approved: MONTELUKAST SODIUM — Supplemental Application (Lannett Company, Inc.)
FDA approved a supplemental application for Montelukast sodium from Lannett Company, Inc., allowing continued marketing of the generic produ…
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FDA approval · 2013-01-31FDA Approved: IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE — Supplemental Application (Cipla USA Inc.)
FDA approved Cipla USA Inc.'s supplemental application for the ipratropium bromide and albuterol sulfate inhalation product (IPRATROPIUM BRO…
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FDA approval · 2013-01-28FDA Approved: MONTELUKAST SODIUM — Supplemental Application (Torrent Pharmaceuticals Limited)
The FDA approved a supplemental application for Montelukast Sodium from Torrent Pharmaceuticals Limited. This action confirms continued mark…
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FDA approval · 2013-01-28FDA Approved: MONTELUKAST SODIUM — Supplemental Application (Torrent Pharmaceuticals Limited)
FDA approved a supplemental ANDA for a generic montelukast sodium product submitted by Torrent Pharmaceuticals Limited.
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FDA approval · 2013-01-25FDA Approved: DULERA — Supplemental Application (Organon LLC)
FDA approved a supplemental application for Dulera (mometasone furoate and formoterol fumarate dihydrate) submitted by Organon LLC.
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FDA approval · 2013-01-15FDA Approved: DULERA — Supplemental Application (Organon LLC)
FDA approved a supplemental application for Dulera (mometasone furoate and formoterol fumarate dihydrate) from Organon LLC.