FDA Updates

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

In 2012, FDA achieved a milestone with the approval of 39 innovative drug therapies for populations in need.

Recent data were released on a long-term, open-label extension study evaluating clobazam for the adjunctive treatment of drop seizures.

New products

A survey of new Rx, new generic, and new OTC products

New Products

A survey of new Rx, new generic, and new OTC products

New products

A survey of new Rx, new generic, and new OTC products

New products

A survey of new Rx, new generic, and new OTC products

New products

A survey of new Rx, new generic, and new OTC products