Content about Food and Drug Administration

January 24, 2011

The Food and Drug Administration has approved a treatment for gastroesphageal reflux disease made by a subsidiary of Mylan, the generic drug maker said Monday.

January 24, 2011

The Food and Drug Administration has approved a new drug for treating major depressive disorder, the agency said Friday.

January 21, 2011

Generic drug maker Watson Pharmaceuticals expects sales of $4.2 billion for 2011, the company said Friday.

January 20, 2011

It seems that MannKind has experienced a setback with a drug designed to control hyperglycemia in Type 1 and Type 2 diabetes patients.

January 20, 2011

The Food and Drug Administration has given tentative approval to an antiretroviral treatment for children with HIV and AIDS under the President’s Emergency Plan for AIDS Relief program.

January 20, 2011

The Food and Drug Administration and Health Canada have granted priority review to a drug for treating hepatitis C.

January 19, 2011

Drug maker Genentech is hoping to keep a breast cancer treatment on the market as the Food and Drug Administration considers whether to revoke its approval for the disease, according to published reports.

January 19, 2011

A permanent injunction was granted to the federal government Tuesday against a contract manufacturer and distributor of prescription and over-the-counter products, as well as two of its executives.

January 19, 2011

In response to articles that appeared in several media outlets about its generic drug pipeline, drug maker Impax Labs is looking to set the record straight.

January 18, 2011

The Food and Drug Administration has approved a new treatment for head lice, the agency said Tuesday.

January 18, 2011

The Food and Drug Administration has approved a generic diabetes drug made by Mylan, the drug maker said Tuesday.

January 18, 2011

Transcept Pharmaceuticals has resubmitted its regulatory application for a drug to treat insomnia to the Food and Drug Administration, following a previous denial of approval by the agency, the drug maker said Tuesday.

January 17, 2011

A new drug application for Anglo-Swedish drug maker AstraZeneca's vandetanib has been extended.

January 17, 2011

A Food and Drug Administration advisory committee voted last week not to recommend approval of a drug from Eli Lilly.

January 17, 2011

After announcing its voluntary recall of certain products at a wholesaler level on Friday, Johnson & Johnson's McNeil Consumer Healthcare division provided an update on its internal assessment phase of its comprehensive action plan.

January 14, 2011

The Food and Drug Administration has approved a new formulation of a drug for treating acetaminophen poisoning.

January 14, 2011

The Food and Drug Administration and drug maker Sanofi-Aventis are warning healthcare professionals and patients about the possibility of severe liver injury in patients taking a Sanofi heart drug.

January 14, 2011

In consultation with the Food and Drug Administration, McNeil Consumer Healthcare on Friday voluntarily recalled certain lots of Tylenol 8 Hour, Tylenol Arthritis Pain and Tylenol upper respiratory products, as well as certain lots of Benadryl, Sudafed PE and Sinutab products at the wholesale level.

January 14, 2011

Pernix Therapeutics Holdings on Wednesday announced an exclusive co-promotion agreement with ParaPro for a medication to treat head lice.

January 13, 2011

The student chapter of the nation’s oldest national pharmacists’ organization has teamed up with the federal government to launch a new outreach effort for improving medication safety.

January 13, 2011

The Food and Drug Administration is capping the amount of the painkiller acetaminophen in prescription drugs due to the risk of liver toxicity, the agency said Thursday.

January 13, 2011

K-V Pharmaceutical announced Wednesday that the Food and Drug Administration extended its Prescription Drug User Fee Act action date to April 13 for a drug under development for preventing preterm birth.

January 13, 2011

Various companies in the healthcare industry are uncertain about the benefits of the Food and Drug Administration’s risk evaluation and mitigation strategy program, and most think it needs a major overhaul, according to a study by the Tufts University Center for the Study of Drug Development.

January 11, 2011

The Food and Drug Administration has accepted a regulatory approval application for a drug to treat Type 2 diabetes made by Merck, the drug maker said Tuesday.

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