Perrigo inhaler road-blocked by the FDA for the third time

May 14, 2018

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.

Show Comments
Hide Comments

Join the discussion

We welcome your thoughtful comments.
All comments will display your user name.

Want to participate in the discussion?

Register for free

Log in for complete access.

Comments

No one has commented on this page yet.

RSS feed for comments on this page | RSS feed for all comments