Endo International has announced that its subsidiary Endo Procurement Operations Limited recently reached an agreement with Merck to distribute an authorized generic of Proventil HFA albuterol sulfate MDI in the US. Endo operating company Par Pharmaceutical has already started shipping the inhaler, the company said.
3M Drug Delivery Systems manufactures Proventil HFA, which was initially approved in 1996, and Merck markets and distributes the MDI. In September 2017, the FDA approved an sNDA for the addition of a dose counter to Proventil HFA, and Merck launched the new version in March 2018.
Par Pharmaceutical President Tony Pera said, “We are very pleased to add albuterol sulfate to Par’s portfolio and to be able to offer the authorized generic of the product to patients. Par has partnered with Merck several times to bring an authorized generic product to market and we are proud to be a reliable, quality supplier.”
Read the Endo press release.
