Sponsors are receiving information requests and complete response letters as a result of the agency’s transition plan, which was made in response to the Genus v. FDA ruling. The decision's aftershocks could reshape the landscape for a number of products, attorney says.

The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker

AbbVie had no presence in ophthalmic medicine other than a single indication for Humira before the Allergan merger, but now has a growing eye care portfolio, including early FDA approval of Vuity for presbyopia.

News and highlights of applications submitted for US FDA approval, from the Pink Sheet’s FDA Performance Tracker