Content about Food and Drug Administration

WHITEHOUSE STATION, N.J. Merck's supplemental drug applications for its atypical antipsychotic received approval from the Food and Drug Administration, the drug maker said.

Saphris now is indicated for the treatment of schizophrenia in adults, as monotherapy for the acute treatment of manic or mixed episodes associated with bipolar I disorder in adults, and as adjunctive therapy with either lithium or valproate for the acute treatment of manic or mixed episodes associated with bipolar I disorder in adults, Merck said.

SILVER SPRING, Md. The Food and Drug Administration recently issued two warning letters to the Dr Pepper Snapple Group and Unilever for their respective green tea beverages, stating that the companies' nutritional claims are not in compliance with FDA regulations.

SAN DIEGO Drug maker Somaxon Pharmaceuticals has made its treatment for insomnia available by prescription, the company said Tuesday.

Somaxon announced the availability of Silenor (doxepin), which received approval from the Food and Drug Administration in March as a treatment for insomnia characterized by difficulty with sleep maintenance.

MORRISTOWN, N.J. The Food and Drug Administration has approved a generic drug made by Actavis for treating attention deficit hyperactivity disorder, Actavis said Wednesday.

The FDA approved the drug maker’s atomoxetine hydrochloride capsules in the 10-mg, 18-mg, 25-mg, 40-mg, 60-mg, 80-mg and 100-mg strengths. The drug is a generic version of Eli Lilly’s Strattera, which had $532 million in sales during the 12-month period ended in June, according to IMS Health.

IRVINE, Calif. Allergan's optimized reformulation of Lumigan has received approval from the Food and Drug Administration, the drug maker said Wednesday.

Lumigan 0.01% (bimatoprost ophthalmic solution) is a first-line therapy indicated for the reduction of elevated intraocular pressure with open-angle glaucoma or ocular hypertension, Allergan said. Lumigan 0.01% will be available in fourth quarter 2010 as the newest addition to Allergan’s comprehensive glaucoma portfolio.

ATLANTA The Food and Drug Administration has granted priority review for a diabetic macular edema treatment.

LONDON The Food and Drug Administration has pushed back its review date for a drug made by GlaxoSmithKline and Valeant Pharmaceuticals.

The FDA has not yet completed the review of the new drug application for ezogabine, a drug designed to treat epileptic adults with partial onset seizures, after a formal risk evaluation and mitigation strategy was submitted to the agency from GSK and Valeant, per its request.

The FDA is expected to review the application by Nov. 30.

FOSTER CITY, Calif. A generic drug maker has filed an abbreviated new drug application for its version of a Gilead Sciences drug.

FOSTER CITY, Calif. A generic drug maker has filed an abbreviated new drug application for its version of a Gilead Sciences drug.

SILVER SPRING, Md. The Food and Drug Administration has posted a new list of drugs from its Adverse Event Reporting System, designed to address potential signals of serious risks and new safety information about drugs on the market.

EAST HANOVER, N.J. The Food and Drug Administration has approved a single-pill combination of two drugs made by Novartis for treating high blood pressure, the Swiss drug maker said Friday.

The FDA approved Tekamlo (aliskiren and amlodipine besylate) tablets, which combine Tekturna (aliskiren) with amlodipine, a channel blocker available as a generic. The drug is approved for treating patients who are likely to need multiple drugs to lower their blood pressure or as a replacement for patients who can’t control it using one of the drugs alone.