Content about Food and Drug Administration

January 30, 2013
FDA panel recommends approval for Boehringer Ingelheim COPD drug

A panel of Food and Drug Administration experts has recommended approval for an experimental drug made by Boehringer Ingelheim for chronic obstructive pulmonary disease, the drug maker said.

January 29, 2013
Citizen's Petition asks that behind-the-counter status be mandated for St. John's Wort

Pharmacists Planning Services, Inc. earlier this month filed a Citizen's Petition with the Food and Drug Administration calling to move St. John's Wort, a mood enhancing supplement, behind the counter.

January 28, 2013
Amneal, South Korea-based Hanmi enter GERD drug deal

U.S. generic drug maker Amneal Pharmaceuticals has entered a deal with South Korean drug maker Hanmi Pharmaceutical to acquire exclusive distribution rights for a Hanmi drug used for treating gastroesophageal reflux disease, Amneal said Monday.

January 28, 2013
FDA accepts application for Genzyme MS drug

The Food and Drug Administration has accepted a regulatory approval application from Genzyme for an experimental treatment for multiple sclerosis, the company said Monday.

January 28, 2013
FDA approves new use of Pfizer vaccine

The Food and Drug Administration has approved a new use for a pneumococcal vaccine made by Pfizer, the drug maker said.

January 28, 2013
FDA approves three new drugs for Type 2 diabetes

The Food and Drug Administration has approved three new drugs for Type 2 diabetes made by Takeda, the agency said.

January 25, 2013
FDA approves Gleevec for most common pediatric cancer

The Food and Drug Administration has approved a Novartis drug for treating leukemia in children.

January 25, 2013
Merck: FDA approves Oxytrol for Women, creating overactive bladder category in OTC

Merck on Friday announced the Food and Drug Administration has approved the switch of Oxytrol for Women (oxybutynin transdermal system, 3.9 mg/day) from prescription-only to nonprescription, creating a new category — overactive bladder in women — in the OTC area.

January 25, 2013
New indication approved for Genentech drug

The Food and Drug Administration has approved a new use for a cancer drug made by Roche unit Genentech, the agency said.

January 23, 2013
FDA approves Novartis drug for rare blood disorder

The Food and Drug Administration has approved a new drug for removing excess iron from the blood in patients with a rare genetic disorder, the agency said.

January 22, 2013
FDA addresses Tamiflu shortages

The Food and Drug Administration on Friday approved the distribution of 2 million additional doses of Tamiflu (oseltamivir phosphate) 75 mg that contain an older version of the package insert.

January 22, 2013
FDA approves Lupin contraceptive

The Food and Drug Administration has approved a generic contraceptive made by Lupin Pharmaceuticals, the drug maker said Tuesday.

January 21, 2013
GSK submits approval application for albiglutide

Drug maker GlaxoSmithKline is seeking Food and Drug Administration approval for a new treatment for Type 2 diabetes, the drug maker said.

January 21, 2013
Reports: State legislation targets biosimilar substitution

While regulations for biosimilars work their way through the Food and Drug Administration, state governments are already looking at legislation concerning the substitution of biosimilars for their branded counterparts, according to a legal affairs blog focused on the FDA.

January 18, 2013
Reports: Roche dips into Tamiflu reserve

The Food and Drug Administration is allowing Roche to tap its reserves of the flu drug Tamiflu, according to published reports.

January 17, 2013
FDA approves Flublok, a trivalent influenza vaccine not made with eggs

The Food and Drug Administration on Wednesday approved Protein Sciences' Flublok, the first trivalent influenza vaccine made using an insect virus (baculovirus) expression system and recombinant DNA technology.

January 17, 2013
FDA approves sterile blood-plasma product

The Food and Drug Administraiton has approved a drug for replacing clotting proteins in the blood for conditions in which patients have too little of them.

January 17, 2013
SIDI Work Group releases voluntary supplier qualification guidelines

The dietary supplement industry’s self-regulatory coalition, the SIDI Work Group, announced the release of its voluntary Dietary Supplement Component Supplier Qualification Guideline — a document designed to assist the industry in supply chain integrity, which is a requirement for complying with current good manufacturing practices.

January 16, 2013
FDA approves Uceris for ulcerative colitis

The Food and Drug Administration has approved an ulcerative colitis drug made by Santarus, the drug maker said.

January 16, 2013
FDA sets generic drug user fee rates for 2013

The Food and Drug Administration has set user fee rates for generic drug companies, the agency said.

January 15, 2013
Reports: Alabama man can sue branded drug makers over generic drug side effects

The state supreme court in Alabama ruled that brand-name drug companies could be sued if patients suffer complications from generic versions of their medicines, according to published reports.

January 14, 2013
U.S., Canadian health authorities report spot shortages of Tamiflu

As if the reported spot shortages of flu vaccine aren't bad enough, there have been reports of similar shortages of flu drugs throughout the United States and parts of Canada due to increased demand.

January 11, 2013
FDA panel recommends approval for J&J Type 2 diabetes drug

A panel of Food and Drug Administration experts has recommended approval for an experimental Type 2 diabetes drug made by Johnson & Johnson, the drug maker said.

January 10, 2013
FDA approves Bayer IUD

The Food and Drug Administration has approved a new intrauterine device for preventing pregnancy made by Bayer HealthCare Pharmaceuticals, the drug maker said.

January 10, 2013
FDA approves Wockhardt epilepsy drug

The Food and Drug Administration has approved a generic epilepsy drug made by Wockhardt, the company said.

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