FDA Updates

New products

New Rx, indications, generics, OTC, and devices.

August is a great time for many families to enjoy the outdoors before school starts. Anyone preparing for a camping trip, a hike, a boating adventure, biking, or just swimming should prepare a first aid kit for any unexpected mishaps. Some new items to add to the kit are described below.

FDA approved levomilnacipran extended-release capsules (Fetzima) for the treatment of major depressive disorder (MDD) in adults, according to the manufacturers, Forest Laboratories and Pierre Fabre Laboratories.

New Products

New Rx, indications, generics, and OTC for pharmacists

Aceto Corporation, Port Washington, N.Y., announced June 11 that its generics subsidiary, Rising Pharmaceuticals Inc., Paramus, N.J., will launch the 50-mg strength of riluzole tablets.

Sandoz has become the first company to gain the FDA approval to produce a generic version of Atacand (candesartan cilexetil).

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 has approved a supplemental new drug application (sNDA) for lubiprostone (Amitiza, Sucampo Pharmaceuticals and Takeda Pharmaceuticals) 24 ?g twice daily as the first oral medication for the treatment of opioid-induced constipation (OIC) in adult patients with chronic, noncancer pain.

New Products

New Rx, generics, OTC, and devices