Content about Food and Drug Administration

March 21, 2011

The generic drug industry’s main lobby in Washington is hoping to head off cuts to the Food and Drug Administration’s Office of Generic Drugs, which it said could have a “devastating impact” on those who rely on generics.

WASHINGTON — The generic drug industry’s main lobby in Washington is hoping to head off cuts to the Food and Drug Administration’s Office of Generic Drugs, which it said could have a “devastating impact” on those who rely on generics.

Republicans in Congress have sought to reduce government spending by making large cuts to various domestic programs and agencies, including the FDA, which critics of the plan said could jeopardize food and drug safety.

March 21, 2011

Nature's Health Connection said its over-the-counter pain-relief cream has garnered record retail sales.

REDFORD, Mich. — Nature's Health Connection said its over-the-counter pain-relief cream has garnered record retail sales.

Sales for Australian Dream — a Food and Drug Administration-approved odorless, greaseless, dye-free and capsaicin-free cream — increased more than 145%, according to the company. Nature's Health Connection attributed the sales spike to a 30-second television commercial. 

Australian Dream is designed to treat minor aches and pains associated with osteo- and rheumatoid arthritis, as well as other muscle ailments.

March 21, 2011

Generic drug maker Mylan is suing the Food and Drug Administration in an effort to prevent Gurgaon, India-based competitor Ranbaxy Labs from launching its generic version of Pfizer’s cholesterol medication Lipitor, according to published reports.

NEW YORK — Generic drug maker Mylan is suing the Food and Drug Administration in an effort to prevent Gurgaon, India-based competitor Ranbaxy Labs from launching its generic version of Pfizer’s cholesterol medication Lipitor, according to published reports.

March 18, 2011

It's about time lawmakers start to understand the real threats posed by drug reimportation and unlicensed Internet pharmacy sites. About 20% of the current members of Congress are newly elected, and there is this recurring, cyclical fascination among politicians that we can fix everything with drug reimportation. But mandating electronic track and trace right now is a bad idea.

WHAT IT MEANS AND WHY IT'S IMPORTANT — It's about time lawmakers start to understand the real threats posed by drug reimportation and unlicensed Internet pharmacy sites. About 20% of the current members of Congress are newly elected, and there is this recurring, cyclical fascination among politicians that we can fix everything with drug reimportation. But mandating electronic track and trace right now is a bad idea.

March 18, 2011

Due to the public concern related to the nuclear incident in Japan, there has been an increased demand for such drugs as potassium iodide (KI), used to prevent and treat the harmful effects of radiation, according to a Food and Drug Administration Web page updated Thursday.

SILVER SPRING, Md. — Due to the public concern related to the nuclear incident in Japan, there has been an increased demand for such drugs as potassium iodide (KI), used to prevent and treat the harmful effects of radiation, according to a Food and Drug Administration Web page updated Thursday.

March 18, 2011

With respect to the Type 2 diabetes drug Avandia, British drug maker GlaxoSmithKline has another medical study to worry about.

LONDON — With respect to the Type 2 diabetes drug Avandia, British drug maker GlaxoSmithKline has another medical study to worry about.

March 18, 2011

Menthol-flavored cigarettes are the latest target for tobacco opponents, according to published reports.

WASHINGTON — Menthol-flavored cigarettes are the latest target for tobacco opponents, according to published reports.

Reuters reported Friday that a committee of advisers to the Food and Drug Administration said in a report that banning mentholated cigarettes would benefit public health. Under legislation adopted in 2009, most flavored cigarettes already are banned.

March 17, 2011

Drug makers Gilead Sciences and Roche are suing Indian drug maker Natco Pharma concerning a generic version of an influenza treatment, according to published reports.

NEW YORK — Drug makers Gilead Sciences and Roche are suing Indian drug maker Natco Pharma concerning a generic version of an influenza treatment, according to published reports.

Bloomberg reported that Gilead and Roche were accusing Natco of patent infringement due to its efforts to gain approval from the Food and Drug Administration for a generic version of Tamiflu (oseltamivir phosphate). Natco became the first company to file for approval of a generic version in February.

March 17, 2011

Anglo-Swedish drug maker AstraZeneca has enrolled the first patient in a late-stage clinical trial for a drug to treat constipation related to use of opioid painkillers, the company said.

WILMINGTON, Del. — Anglo-Swedish drug maker AstraZeneca has enrolled the first patient in a late-stage clinical trial for a drug to treat constipation related to use of opioid painkillers, the company said.

March 17, 2011

Commenting on a counterfeit pharmaceutical inter-agency working group report, the National Association of Chain Drug Stores stressed that it shares the goal of improving the public awareness of the risks posed from counterfeit drugs and unlawful online drug sellers, but expressed concern over the report's proposal to mandate a "track-and-trace" system in the United States, given the high cost it could pose for pharmacies.

ALEXANDRIA, Va. — Commenting on a counterfeit pharmaceutical inter-agency working group report, the National Association of Chain Drug Stores stressed that it shares the goal of improving the public awareness of the risks posed from counterfeit drugs and unlawful online drug sellers, but expressed concern over the report's proposal to mandate a "track-and-trace" system in the United States, given the high cost it could pose for pharmacies.

March 17, 2011

The Natural Products Association on Wednesday outlined five key industry issues for the U.S. Department of Commerce and the Office of the United States Trade Representative for the U.S.-China Joint Commission on Commerce and Trade.

WASHINGTON — The Natural Products Association on Wednesday outlined five key industry issues for the U.S. Department of Commerce and the Office of the United States Trade Representative for the U.S.-China Joint Commission on Commerce and Trade.

The NPA focused on removing barriers for trade to China with recommendations on increasing transparency, clarifying and reforming regulations, and enhancing export opportunities.

March 16, 2011

The Food and Drug Administration on Wednesday announced that the only over-the-counter asthma inhaler sold in the United States no longer will be available as of Dec. 31 as part of an international agreement to stop the use of substances that damage the environment.

SILVER SPRING, Md. — The Food and Drug Administration on Wednesday announced that the only over-the-counter asthma inhaler sold in the United States no longer will be available as of Dec. 31 as part of an international agreement to stop the use of substances that damage the environment.

March 15, 2011

A drug under investigation as a treatment for a rare genetic disorder that causes abnormally high triglyceride levels in the blood has received orphan-drug designation from the Food and Drug Administration.

CAMBRIDGE, Mass. — A drug under investigation as a treatment for a rare genetic disorder that causes abnormally high triglyceride levels in the blood has received orphan-drug designation from the Food and Drug Administration.

March 15, 2011

A generic painkiller made by Watson Pharmaceuticals does not infringe on the patent covering the branded version, a U.S. District Court has ruled.

MORRISTOWN, N.J. — A generic painkiller made by Watson Pharmaceuticals does not infringe on the patent covering the branded version, a U.S. District Court has ruled.

Watson said the U.S. District Court for the District of Delaware ruled that Watson’s generic version of Cephalon’s Fentora (fentanyl buccal tablets) does not infringe on two patents that were set to expire in March 2019, according to Food and Drug Administration records.

March 15, 2011

The Food and Drug Administration on Tuesday outlined a new campaign attacking fraudulent weight-loss products marketed as dietary supplements, especially those companies that proffer a “magic pill” that almost immediately achieves weight loss.

SILVER SPRING, Md. — The Food and Drug Administration on Tuesday outlined a new campaign attacking fraudulent weight-loss products marketed as dietary supplements, especially those companies that proffer a “magic pill” that almost immediately achieves weight loss.

March 15, 2011

Five senators have issued a letter to Food and Drug Administration commissioner Margaret Hamburg to expand Americans' access to affordable medications by avoiding the delay of generic drug approvals.

WASHINGTON — Five senators have issued a letter to Food and Drug Administration commissioner Margaret Hamburg to expand Americans' access to affordable medications by avoiding the delay of generic drug approvals.

March 15, 2011

Patients that opt to fill their prescriptions through a $4 generic program could help garner societal savings of nearly $6 billion, a new study found.

PITTSBURGH — Patients that opt to fill their prescriptions through a $4 generic program could help garner societal savings of nearly $6 billion, a new study found.

March 14, 2011

McNeil last week finalized the terms of a consent decree of permanent injunction with the Food and Drug Administration for manufacturing facilities operated by the McNeil Consumer Healthcare Division in Las Piedras, Puerto Rico; Fort Washington, Pa.; and Lancaster, Pa.

FORT WASHINGTON, Pa. — McNeil last week finalized the terms of a consent decree of permanent injunction with the Food and Drug Administration for manufacturing facilities operated by the McNeil Consumer Healthcare Division in Las Piedras, Puerto Rico; Fort Washington, Pa.; and Lancaster, Pa.

The consent decree is subject to approval by the U.S. District Court for the Eastern District of Pennsylvania.

March 11, 2011

The Food and Drug Administration has approved biotech company Dendreon’s expansion of manufacturing capacity for an immunotherapy treatment for prostate cancer, Dendreon said Thursday.

SEATTLE — The Food and Drug Administration has approved biotech company Dendreon’s expansion of manufacturing capacity for an immunotherapy treatment for prostate cancer, Dendreon said Thursday.

The company said it would be able to increase the ability of Provenge (sipuleucel-T) manufactured at its plant in New Jersey by increasing the number of workstations to produce it from 12 to 48.

The treatment is designed to induce an immune response against prostatic acid phosphatase, an antigen present in most prostate cancers.

March 10, 2011

The Food and Drug Administration has approved a treatment for lupus made by GlaxoSmithKline and Human Genome Sciences, the agency said Wednesday.

SILVER SPRING, Md. — The Food and Drug Administration has approved a treatment for lupus made by GlaxoSmithKline and Human Genome Sciences, the agency said Wednesday.

The FDA approved Benlysta (belimumab), a treatment for systemic lupus erythematosus, the first new treatment for the autoimmune disease in 56 years.

March 10, 2011

The Food and Drug Administration is putting its weight behind a campaign by the National Consumers League to combat poor medication adherence.

SILVER SPRING, Md. — The Food and Drug Administration is putting its weight behind a campaign by the National Consumers League to combat poor medication adherence.

March 10, 2011

Hospira has received approval from the Food and Drug Administration for a generic cancer treatment.

LAKE FOREST, Ill. — Hospira has received approval from the Food and Drug Administration for a generic cancer treatment.

Hospira will offer 20-mg, 80-mg and 160-mg vials of docetaxel at a 10-mg/mL concentration. Docetaxel is a generic version of Sanofi-Aventis's Taxotere.

Hospira already markets docetaxel in Europe and Australia, the drug maker noted.

March 10, 2011

A subsidiary of Mylan has won approval to sell a generic drug for HIV and AIDS in developing countries under the President’s Emergency Plan for AIDS Relief.

PITTSBURGH — A subsidiary of Mylan has won approval to sell a generic drug for HIV and AIDS in developing countries under the President’s Emergency Plan for AIDS Relief.

Mylan announced Thursday that Matrix Labs won Food and Drug Administration approval for zidovudine tablets in the 100-mg strength. The drug is a generic version of ViiV Healthcare’s Retrovir, an antiretroviral sold as a water-dispersible tablet. The drug is designed to treat HIV and AIDS in children and prevent transmission of the virus from pregnant mothers to their children.

March 9, 2011

FRS Healthy Energy on Tuesday announced the launch of new Healthy Protein and Healthy Energy formulas to be shipped in April.

FOSTER CITY, Calif. — FRS Healthy Energy on Tuesday announced the launch of new Healthy Protein and Healthy Energy formulas to be shipped in April.

Both products will be fueled by the patented FRS quercetin formula, the company said. Quercetin, recently granted GRAS — generally recognized as safe — status by the Food and Drug Administration, is the natural energy-boosting antioxidant contained in all FRS products. To date, FRS Healthy Energy products contain the highest level of quercetin (QU995) on the market, the company claimed.

March 9, 2011

The Food and Drug Administration has accepted an approval application from Merck for a drug to treat eye diseases, Merck said Wednesday.

WHITEHOUSE STATION, N.J. — The Food and Drug Administration has accepted an approval application from Merck for a drug to treat eye diseases, Merck said Wednesday.

Merck is seeking approval for Saflutan (tafluprost) ophthalmic solution, an investigational drug for relieving eye pressure in patients with glaucoma and ocular hypertension.