Content about Food and Drug Administration

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.

March 9, 2011

The Food and Drug Administration has accepted a regulatory approval application from Tris Pharma for a drug to treat allergies in children ages 2 years and older, Tris said Wednesday.

MONMOUTH JUNCTION, N.J. — The Food and Drug Administration has accepted a regulatory approval application from Tris Pharma for a drug to treat allergies in children ages 2 years and older, Tris said Wednesday.

Tris said that if approved, its carbinoxamine extended-release oral suspension would provide an alternative to currently available immediate-release formulations.

March 8, 2011

The Food and Drug Administration has accepted a regulatory approval application for a Type 2 diabetes drug from Bristol-Myers Squibb and AstraZeneca, the two drug makers said Tuesday.

PRINCETON, N.J. — The Food and Drug Administration has accepted a regulatory approval application for a Type 2 diabetes drug from Bristol-Myers Squibb and AstraZeneca, the two drug makers said Tuesday.

The FDA accepted the application for dapagliflozin, an investigational drug for adults with the disease. The Centers for Disease Control and Prevention estimated that 1-in-11 U.S. adults has diabetes, with 90% to 95% of them having Type 2 diabetes.

The agency expects to take action on the application in late October.

March 8, 2011

The Food and Drug Administration declined to approve a drug made by Salix Pharmaceuticals for irritable bowel syndrome, Salix said Tuesday.

RALEIGH, N.C. — The Food and Drug Administration declined to approve a drug made by Salix Pharmaceuticals for irritable bowel syndrome, Salix said Tuesday.

The FDA issued a complete response letter to Salix for Xifaxan (rifaximin), a treatment for nonconstipation IBS and IBS-related bloating. Salix said it had anticipated that it would receive the letter based on an understanding that the agency needed more information related to retreatment.

March 4, 2011

The Food and Drug Administration has approved a drug made by Eisai to treat a rare form of epilepsy, the drug maker said Friday.

WOODCLIFF LAKE, N.J. — The Food and Drug Administration has approved a drug made by Eisai to treat a rare form of epilepsy, the drug maker said Friday.

The FDA approved Banzel (rufinamide) oral suspension for the treatment of seizures in children and adults with Lennox-Gastaut syndrome. The condition, also called LGS, affects 1% to 4% of children with epilepsy.

“This new formulation provides an option for patients who may prefer a liquid or find it difficult to take the medication in tablet form,” Eisai president and CEO Lonnel Coats said.

March 4, 2011

Gilead on Friday announced that the Food and Drug Administration has removed a boxed warning about a possible liver injury risk caused by the drug maker's hypertension treatment.

FOSTER CITY, Calif. — Gilead on Friday announced that the Food and Drug Administration has removed a boxed warning about a possible liver injury risk caused by the drug maker's hypertension treatment.

Gilead said the FDA approved a change to the prescribing information for Letairis (ambrisentan 5-mg and 10-mg tablets), the company’s once-daily treatment of pulmonary arterial hypertension.

March 4, 2011

Pregnant mothers taking a common drug for treating epilepsy may be putting their babies at risk, according to a new report from the Food and Drug Administration.

SILVER SPRING, Md. — Pregnant mothers taking a common drug for treating epilepsy may be putting their babies at risk, according to a new report from the Food and Drug Administration.

The FDA said Friday that the drug topiramate could increase the risk for such birth defects as cleft palate and cleft lip when used by expectant mothers. Johnson & Johnson markets the drug under the name Topamax, and it is available in generic form.

March 4, 2011

A subsidiary of Endo Pharmaceuticals has won approval from the Food and Drug Administration for an oral contraceptive.

HUNTSVILLE, Ala. — A subsidiary of Endo Pharmaceuticals has won approval from the Food and Drug Administration for an oral contraceptive.

Qualitest Pharmaceuticals announced Friday the approval of Emoquette (desogestrel and ethinyl estradiol) tablets in the 0.15-mg/0.03-mg strength.

The drug is a generic version of Johnson & Johnson’s Ortho-Cept.