Content about Food and Drug Administration

McLEAN, Va. The Council for Responsible Nutrition’s president and CEO Steve Mister supplied the “opposing view” to a USA Today opinion piece published online Thursday regarding a recent Consumer Reports attack on the dietary supplement industry.

CARY, N.C. Generic drug maker Cornerstone Therapeutics has filed for approval of a treatment for cold symptoms, Cornerstone said Thursday.

The drug maker announced the filing of an application with the Food and Drug Administration for CRTX-067 (chlorpheniramine polistirex and hydrocodone polistirex) oral suspension, a generic version of UCB’s Tussionex.

BALTIMORE WellDoc, a healthcare company that develops technology solutions to improve chronic disease management outcomes and reduce healthcare costs, on Monday announced that it has received Food and Drug Administration 510(k) clearance to market the WellDoc DiabetesManager System to healthcare providers and their adult patients with Type 2 diabetes.

GREENSBORO, N.C. The Food and Drug Administration has approved a treatment for muscle spasms and twitches.

SCHAUMBURG, Ill. The Food and Drug Administration has approved a generic injected drug made by Sagent Pharmaceuticals for treating migraine attacks, Sagent said Monday.

The FDA approved Sagent’s sumatriptan succinate injection in the 6 mg per 0.5 milliliter strength. The drug is used to treat acute migraine attacks and cluster headache episodes.

Sumatriptan is a generic version of GlaxoSmithKline’s Imitrex. Injectable sumatriptan had $22 million in sales in 2009, according to IMS Health.

SILVER SPRING, Md. The Food and Drug Administration has approved the first generic version of a Sanofi-Aventis injected drug used to treat deep vein thrombosis, the agency said Friday.

The FDA approved generic enoxaparin sodium, a version of Sanofi’s Lovenox, developed under a collaboration between Momenta Pharmaceuticals and Sandoz, the generics division of Swiss drug maker Novartis.

WASHINGTON While there is a need to modernize the regulatory structure of the cosmetics industry, the newly proposed Safe Cosmetics Act of 2010 as written "is not based on credible and established scientific principles" and would place an "enormous, if not impossible, burden on the Food and Drug Administration," the Personal Care Products Council stated in response to the legislation introduced on Wednesday.

MORRISTOWN, N.J. Actavis has received regulatory approval from the Food and Drug Administration for a generic antidepressant, the drug maker announced Wednesday.

Actavis said it immediately will begin distributing its bupropion HCl extended-release (SR) tablets in 100-mg and 200-mg strengths. The drug is the generic equivalent of GlaxoSmithKline's Wellbutrin SR. Actavis already has marketed generic Wellbutrin SR in the 150-mg strength. The drug maker received approval in March 2008.