Perrigo Generic Of Teva's ProAir Stunned By Another FDA CRL

14 May 2018

• By Sten Stovall

Perrigo has got another Complete Response Letter on its generic version of Teva's ProAir, the company’s fourth to date, prompting a cut in its 2018 EPS guidance.

RX form — Perrigo Getting fourth CRL on its ProAir generic • Source: Shutterstock

Perrigo Co. PLC has adjusted its full-year guidance downwards for 2018 after receiving a Complete Response Letter (CRL) from the US FDA for its generic version of Teva's ProAir inhaler asthma treatment, because it now no longer expects to launch the copycat product in 2018.

The FDA informed Perrigo via teleconference late on May 10 that it was issuing a CRL on the ProAircopy –...