Amphastar Receives FDA Approval for Ipratropium Bromide Inhalation Aerosol
Amphastar announced that the FDA has approved the company's abbreviated new drug application, or ANDA, for Ipratropium Bromide HFA Inhalation Aerosol 17mcg/actuation. The FDA determined that Amphastar's Ipratropium Bromide HFA Inhalation Aerosol is bioequivalent and therapeutically equivalent to Boehringer Ingelheim's Atrovent HFA Inhalation Aerosol. Additionally, the FDA has confirmed that this product is eligible for 180-days of generic drug exclusivity for Ipratropium Bromide HFA Inhalation Aerosol as we were the first ANDA applicant with Paragraph IV certification. This exclusivity period will begin on the first day that Amphastar's Ipratropium Bromide HFA Inhalation Aerosol is commercially launched.
