FDA Updates

Intersect ENT Announces Approval for Implant for Chronic Sinusitis Patients

Intersect ENT, Inc., an innovator in treatment alternatives for ear, nose and throat clinicians and patients, today announced that the U.S. Food and Drug Administration (FDA) has approved the company’s Pre-market Approval (PMA) application for the Propel™ mometasone furoate implant offering localized, controlled drug delivery for chronic sinusitis patients.

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FDA Prompts Removal of Unapproved Drugs From Market

The U.S. Food and Drug Administration today took action against companies that manufacture, distribute, or market certain unapproved prescription oral cough, cold, and allergy products. The affected products cannot be legally marketed in the United States.

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FDA Approves Dulera® Inhalation Aerosol for the Treatment of Asthma

The U.S. Food and Drug Administration has approved Merck’s Dulera Inhalation Aerosol, a new fixed-dose combination asthma treatment for people 12 years of age and older.

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FDA Updates U.S. Product Labels for LABA-Containing Medications

The FDA has released final label revisions for respiratory medications that contain an active ingredient known as a long-acting beta-agonist (LABA).

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