This article is more than 5 years old. Information may no longer be current.
FDA adds ocular indication for Humira, issues complete response letters
Click Here to Manage Email Alerts
Recent FDA activity includes the addition of an ocular indication for AbbVie’s Humira and the issuance of two complete response letters, one to Ocular Therapeutix and one to Valeant, citing manufacturing concerns. Ocular Surgery News compiled these stories from Healio.com/OSN.
FDA approves Humira for treatment of noninfectious intermediate, posterior and panuveitis
The FDA has approved Humira for the treatment of noninfectious intermediate and posterior uveitis and panuveitis, according to a press release from AbbVie. Read more
FDA raises concerns about manufacturing facility in latanoprostene bunod complete response letter to Valeant
Valeant received a complete response letter from the FDA regarding the new drug application for latanoprostene bunod ophthalmic solution 0.024%, a once-daily topical eye drop for patients with open-angle glaucoma or ocular hypertension, according to a press release. Read more
FDA raises concerns about manufacturing deficiencies in Dextenza complete response letter
Ocular Therapeutix received a complete response letter from the FDA regarding the new drug application for Dextenza for the treatment of postoperative ocular pain, according to a press release. Read more