The FDA informed Perrigo during a May 10, 2018 teleconference that the agency will issue a complete response letter to the company’s ANDA for its generic version of Teva’s ProAir albuterol MDI, Perrigo said. As a result, the company no longer expects to launch its albuterol inhaler by the end of 2018.
Perrigo filed an ANDA for the generic version of ProAir in 2012, and Teva filed a patent infringement suit in response. In 2014, the companies reached a settlement that would give Perrigo a license to market its version of ProAir in unlimited quantities beginning in July 2018.
Perrigo said that it will decide how to proceed from here after it receives the CRL and has a chance to analyze the FDA’s comments.
Read the Perrigo press release.
