Amphastar Pharmaceuticals announced that the FDA has approved the company’s ANDA for a generic version of Teva’s ProAir HFA albuterol MDI for the treatment of asthma and said that it plans to launch the inhaler in the 3rd quarter of 2024. Amphastar’s currently marketed OINDPs include Baqsimi intranasal dry powder glucagon, Rextovy naloxone nasal spray, and Primatene Mist epinephrine MDI.
According to the announcement, Amphastar is developing additional products for injectable and nasal delivery and has 3 ANDAs currently on file with the FDA. The company’s web site says that “Some of the products Amphastar has chosen to develop are on the FDA’s shortage list or are products that have been off patent but have not been pursued by other companies because they are technically challenging to develop or manufacture.”
Amphastar President and CEO Jack Zhang commented, “Our first generic inhalation product’s approval reflects both our technological and manufacturing ability. While patients can benefit from increased access to this combination drug product, we are proud to manufacture the finished product in the United States, as our commitment to quality remains our top priority. This approval sets a solid foundation for future growth in developing our other generic inhalation products, highlighting our expertise in developing complex products.”
Read the Amphastar Pharmaceuticals press release.
