Clinical

Articles

FDA approved a new fixed-dose combination ophthalmic suspension of a carbonic anhydrase inhibitor (brinzolamide 1.0%) and an alpha 2 adrenergic receptor agonist (brimonidine tartrate 0.2%), which is indicated for the reduction of intraocular pressure in patients with primary open-angle glaucoma or ocular hypertension.

FDA approves combination glaucoma drop without beta-blocker

New molecular entity: FDA approved tafluprost 0.0015% (Zioptan, Merck) ophthalmic solution to reduce elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension.

Zioptan (Tafluprost 0.0015% ophthalmic solution): An opthalmic solution to reduce elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension

Recent FDA Approvals (through May 2012) related to (Meda, Novo Nordisk, Janssen, Vivus, Clinigen, GlaxoSmithKline, Stride Arcolab)

FDA Actions in Brief May 2012

Recent FDA Approvals (through April 2012) related to (Johnson & Johnson, AstraZeneca, Affymax, Takeda Pharmaceutical, Teva Pharmaceutical Industries, Avioq, Hope Pharmaceuticals, Novo Nordisk, Avid Radiopharmaceuticals)

FDA Actions in Brief April 2012

Recent FDA Approvals (through February 2012) related to (Corcept Therapeutics, Merck, Amylin Pharmaceuticals, Alkermes, Sanofi, Mobius Therapeutics, Vertex Pharmaceuticals, Boehringer Ingelheim, Eli Lilly, Pfizer, UCB, Curis, Genentech, Novartis)

FDA Actions in Brief March 2012 (Corcept Therapeutics, Merck, Amylin Pharmaceuticals, Alkermes, Sanofi, Mobius Therapeutics, Vertex Pharmaceuticals, Boehringer Ingelheim, Eli Lilly, Pfizer, UCB, Curis, Genentech, Novartis)

New molecular entity: Aflibercept once-monthly intravitreal injection is FDA approved to treat patients with wet (neovascular) age-related macular degeneration.

Aflibercept (Eylea): A monthly intravitreal injection for wet age-related macular degeneration (AMD)

Recent FDA action (through December 2011) related to staccato loxapine, axitinib, mydicar, kalydeco, riboflavin ophthalmic solution, minocycline hydrochloride

FDA Pipeline Preview, January 2012 (Alexza Pharmaceuticals, Pfizer, Celladon, Vertex, Avedro)

Two of the most commonly used treatments for neovascular age-related macular degeneration, ranibizumab, approved by FDA in 2006, and the other commonly used 'off-label', bevacizumab, resulted in similar improvements in visual acuity, according to results of a new trial.

Ranibizumab and bevacizumab show equivalent effects on visual acuity in patients with neovascular AMD

Generic drugs approved by FDA (through May 2011): bromfenac ophthalmic solution 0.09%, sodium ferric gluconate complex in sucrose injection, nitrofurantoin oral suspension

First-time generic approval June 2011

Two of the most commonly used treatments for neovascular AMD, ranibizumab (Lucentis, Genentech), approved in 2006 by FDA, and the other commonly used ?off-label,? bevacizumab (Avastin, Genentech), resulted in similar improvements in visual acuity, according to a new randomized controlled trial published in NEJM.