Content about Food and Drug Administration

May 17, 2011

Perrigo on Monday announced that it has received final approval from the Food and Drug Administration for its abbreviated new drug application for over-the-counter ranitidine 150 (regular and cool mint), a generic version of Zantac 150.

May 16, 2011

The Food and Drug Administration is convening its Nonprescription Drugs Advisory Committee Tuesday and Wednesday to debate mandating weight-based dosing for pediatric medicines containing acetaminophen on the Drug Facts label, as well as the potential expansion of dosing instructions to incorporate children under the age of 2 years old, according to material posted online by the FDA on Friday.

May 16, 2011

The Food and Drug Administration on Friday warned consumers about a counterfeit product represented as "ExtenZe," which is the name of an authentic dietary supplement for male sexual enhancement.

May 16, 2011

Drug maker Mylan has launched a generic treatment for muscle spasms, the company said Friday.

May 16, 2011

The Food and Drug Administration has approved a new treatment for chronic hepatitis C, the agency said Friday.

May 13, 2011

More than 800 drugs are in development for diseases that affect women, according to a pharmaceutical industry lobbying group.

May 11, 2011

The American Pharmacists Association has published its white paper on risk evaluation and mitigation strategies, the group said.

May 11, 2011

A recent Food and Drug Administration inspection prompted the recall of dietary supplements distributed by Multi-Mex Distributor, the company announced Monday. According to an FDA post, the supplements in question bore a close resemblance to antibiotics available in Mexico and may have been confusing to Hispanic consumers.

May 11, 2011

Genentech is seeking approval for a new drug to treat skin cancer, the company said Wednesday.

May 10, 2011

The Food and Drug Administration will expedite its review of an investigational drug made by Bayer HealthCare Pharmaceuticals for treating tumors of the gastrointestinal tract, the company said Tuesday.

May 10, 2011

Sanofi’s vaccines division has won Food and Drug Administration approval for a vaccine designed for injection into the skin, the company said Tuesday.

May 10, 2011

The branded-drug division of Impax Labs plans to conduct early-stage clinical studies of an investigational drug for restless leg syndrome, the company said Tuesday.

May 10, 2011

The Food and Drug Administration expects to approve an increasing number of drugs, according to published reports.

May 9, 2011

The Food and Drug Administration is moving forward in the creation of a regulatory approval pathway for follow-on biologics and is requesting input from stakeholders and the public, the agency said Monday.

May 9, 2011

The Food and Drug Administration has granted orphan drug designation to a treatment made by Mithridion for a rare neurological disorder, Mithridion said Monday.

May 6, 2011

The Food and Drug Administration has approved a drug made by Novartis as the first treatment for advanced pancreatic neuroendocrine tumors, Novartis said Thursday.

May 5, 2011

The Food and Drug Administration has unveiled two regulations, part of the newly enacted Food Safety Modernization Act, that will take effect in July.

May 5, 2011

The Food and Drug Administration on Wednesday released the Dosage Delivery Devices for Orally Ingested OTC Liquid Drug Products guidance, which outlines how easy-to-use dosage delivery devices and devices that minimize the risk of unintentional overdose can be provided for such over-the-counter medicines as liquid pain relievers, cold medicine, cough syrups and digestion aids.

May 5, 2011

A major depressive disorder treatment made by Pfizer significantly reduced the number and severity of moderate-to-severe hot flashes in postmenopausal women, compared with placebo, according to a new study.

May 4, 2011

The Food and Drug Administration is cracking down on companies that it accuses of selling fake products for sexually transmitted diseases, the agency said.

May 4, 2011

The Food and Drug Administration has approved a generic oral contraceptive made by Sandoz, the generics arm of Swiss drug maker Novartis said Wednesday.

May 3, 2011

Sales at generic drug maker Mylan increased by 12% during first quarter 2011, compared with first quarter 2010, the company said Tuesday.

May 3, 2011

The Food and Drug Administration has approved a generic version of Rogaine made by Perrigo, the drug maker said.

May 2, 2011

The Food and Drug Administration has approved a treatment made by Abbott for low testosterone in men, the drug maker said Friday.

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