The third time’s not the charm for the approval of Perrigo Co.’s generic version of Teva’s best-selling ProAir inhaler. According to the company, the FDA plans to issue a complete response letter that will effectively reject Perrigo’s third application for the device.
Perrigo did not explain what the FDA’s reasons are for the rejection, but said it does not expect to “meet its goal of launching a generic version of ProAir in the fourth quarter of 2018.”
The announcement is good news for Teva, which had to lay off 14,000 employees last year due to plummeting sales. ProAir, an alburterol sulfate aerosol inhaler, generated $501 million for Teva last year.
Read the full Bloomberg report.