Branded

Intra-Cellular plans to launch Caplyta in the first quarter of this year.

Enhertu is indicated for the treatment of patients with unresectable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens.

Twenty-nine of the 48 novel drug approvals of 2019, or 60%, were designated in one or more expedited categories of Fast Track, Breakthrough, Priority Review, and/or Accelerated Approval.

Warner Chilcott and Watson subsidiaries will pay approximately $300 million under settlement agreements.

Daiichi Sankyo's Enhertu provides a new treatment option for patients with HER2-positive breast cancer who have progressed on available therapies.

Ubrelvy is the first and only oral calcitonin gene-related peptide receptor antagonist for the treatment of migraine attacks once they start.

Vascepa was originally approved as an adjunct to diet to reduce triglyceride levels in adult patients with severe hypertriglyceridemia.

Arazlo is the first FDA approved tazarotene acne treatment in a lotion formulation.