FDA approves Amphastar’s Ipratropium Bromide HFA inhalation aerosol ANDA

Reuters

4 hours ago

FDA approves Amphastar’s Ipratropium Bromide HFA inhalation aerosol ANDA

Amphastar Pharmaceuticals Inc. said the U.S. Food and Drug Administration approved its Abbreviated New Drug Application for Ipratropium Bromide HFA Inhalation Aerosol 17 mcg/actuation. The FDA determined the product is bioequivalent and therapeutically equivalent to Boehringer Ingelheim’s Atrovent HFA, and confirmed Amphastar is eligible for 180 days of generic drug exclusivity starting on the first day of commercial launch.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Amphastar Pharmaceuticals Inc. published the original content used to generate this news brief via ACCESS Newswire (Ref. ID: 202602240600ACCESSWRNAPR_____1140380) on February 24, 2026, and is solely responsible for the information contained therein.

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