Content about Food and Drug Administration

March 29, 2011

One could say that a job with the Food and Drug Administration would be the perfect way to get information about upcoming drug approvals and use it to profit handsomely from buying stock in the companies that manufacture the drugs before the information reaches the public.

WASHINGTON — One could say that a job with the Food and Drug Administration would be the perfect way to get information about upcoming drug approvals and use it to profit handsomely from buying stock in the companies that manufacture the drugs before the information reaches the public.

Of course, the Securities and Exchange Commission would consider that illegal insider trading, as one FDA scientist recently discovered.

March 29, 2011

A decision by the Food and Drug Administration to lower the age at which patients can receive a vaccine for shingles opens the door for pharmacists to administer it to more patients.

CAMP HILL, Pa. — A decision by the Food and Drug Administration to lower the age at which patients can receive a vaccine for shingles opens the door for pharmacists to administer it to more patients.

Rite Aid said Tuesday that pharmacists at more than 2,100 of its stores now could vaccinate patients ages 50 years and older with Merck’s Zostavax (zoster vaccine live) thanks to the FDA’s approval of the vaccination for patients in that age group. Previously, it was only approved for patients ages 60 years and older.

March 29, 2011

Generic drug maker Watson Pharmaceuticals is hoping to become the first to market a version of a popular opioid painkiller.

MORRISTOWN, N.J. — Generic drug maker Watson Pharmaceuticals is hoping to become the first to market a version of a popular opioid painkiller.

Watson said it had filed applications with the Food and Drug Administration seeking approval for a generic version of Purdue Pharma’s OxyContin (oxycodone) extended-release tablets in the 10-, 15-, 20-, 30-, 40-, 60- and 80-mg strengths.

March 28, 2011

The Food and Drug Administration has approved a topical treatment for genital warts made by Graceway Pharmaceuticals, the drug maker said Monday.

BRISTOL, Tenn. — The Food and Drug Administration has approved a topical treatment for genital warts made by Graceway Pharmaceuticals, the drug maker said Monday.

The FDA approved Zyclara (imiquimod) cream in the 3.75% strength for patients ages 12 years and older. According to clinical trial data, the cream effectively cleared genital warts, and of patients who achieved complete clearance, only a small percentage had a recurrence 12 weeks after treatment.

March 28, 2011

The Food and Drug Administration on Monday warned consumers to stop using Soladek, a vitamin-solution product marketed by Indo Pharma of the Dominican Republic, because the product may contain dangerously high levels of vitamins A and D.

SILVER SPRING, Md. — The Food and Drug Administration on Monday warned consumers to stop using Soladek, a vitamin-solution product marketed by Indo Pharma of the Dominican Republic, because the product may contain dangerously high levels of vitamins A and D.

The FDA received seven reports of serious health problems occurring in consumers using the product. The problems include decreased renal function, elevated levels of calcium in the blood, fatigue, heart arrhythmia, vomiting and diarrhea.
 

March 28, 2011

The U.S. Pharmacopeial Convention last week announced that it is working with the Food and Drug Administration and the Consumer Healthcare Products Association to update quality standards for widely used medicines and ingredients. Updated test methodologies are crucial to help counter economically motivated adulteration — in which less expensive and potentially harmful ingredients are substituted for genuine medicines or their ingredients — and also to address the challenge of impurities that may go undetected with older, nonspecific assays and tests.

ROCKVILLE, Md. — The U.S. Pharmacopeial Convention last week announced that it is working with the Food and Drug Administration and the Consumer Healthcare Products Association to update quality standards for widely used medicines and ingredients. Updated test methodologies are crucial to help counter economically motivated adulteration — in which less expensive and potentially harmful ingredients are substituted for genuine medicines or their ingredients — and also to address the challenge of impurities that may go undetected with older, nonspecific assays and tests.

March 25, 2011

The Food and Drug Administration has approved a new treatment for late-stage skin cancer, the agency said Friday.

SILVER SPRING, Md. — The Food and Drug Administration has approved a new treatment for late-stage skin cancer, the agency said Friday.

The FDA approved Bristol-Myers Squibb’s Yervoy (ipilimumab) for patients with melanoma that has spread to other parts of the body, also known as metastasis. More than 68,000 new cases of melanoma were diagnosed in the United States in 2010, and about 8,700 died from it, according to the National Cancer Institute, part of the National Institutes of Health.

March 25, 2011

The Food and Drug Administration has approved a vaccine for shingles in older patients.

SILVER SPRING, Md. — The Food and Drug Administration has approved a vaccine for shingles in older patients.

The agency said Thursday that it had approved Merck’s Zostavax (zoster vaccine live) vaccine in patients ages 50 to 59 years. The vaccine already is approved for those ages 60 years and older.

Shingles, caused by the varicella-zoster virus, the same virus that causes chickenpox, affects about 200,000 people in the United States ages 50 to 59 years each year.

March 24, 2011

Sugar and chalk. That’s what Pfizer researchers found in a pill that was supposed to be Cytotec, but was, in fact, a crude knockoff seized from a counterfeit drug lab in Peru.

Sugar and chalk. That’s what Pfizer researchers found in a pill that was supposed to be Cytotec, but was, in fact, a crude knockoff seized from a counterfeit drug lab in Peru.

March 24, 2011

The Food and Drug Administration has approved a generic treatment for shingles and genital herpes made by Actavis, the drug maker said Wednesday.

MORRISTOWN, N.J. — The Food and Drug Administration has approved a generic treatment for shingles and genital herpes made by Actavis, the drug maker said Wednesday.

The FDA approved Actavis’ valacyclovir hydrochloride tablets in the 500-mg and 1-g strengths.

The drug is a generic version of GlaxoSmithKline’s Valtrex. Branded and generic forms of the drug had sales of about $1.5 billion in 2010, according to IMS Health.

March 24, 2011

Bristol-Myers Squibb said its late-stage clinical trial for a cancer treatment, which currently is under review by the Food and Drug Administration, achieved its primary endpoint.

PRINCETON, N.J. — Bristol-Myers Squibb said its late-stage clinical trial for a cancer treatment, which currently is under review by the Food and Drug Administration, achieved its primary endpoint.

The company said its phase-3 trial for investigational compound ipilimumab, designed for previously untreated patients that were diagnosed with metastatic melanoma, improved overall survival. The study compared the combination of ipilimumab 10 mg/kg and chemotherapy (dacarbazine) with chemotherapy alone.

March 24, 2011

The Food and Drug Administration has extended its regulatory review period for Novartis' new drug application for its once-daily, long-term maintenance bronchodilator treatment of airflow obstruction in patients with chronic obstructive pulmonary disease, as well as chronic bronchitis and/or emphysema, the drug maker said.

BASEL, Switzerland — The Food and Drug Administration has extended its regulatory review period for Novartis' new drug application for its once-daily, long-term maintenance bronchodilator treatment of airflow obstruction in patients with chronic obstructive pulmonary disease, as well as chronic bronchitis and/or emphysema, the drug maker said.

March 24, 2011

Four-in-5 menthol smokers would quit if the Food and Drug Administration banned mentholated cigarettes, according to a survey conducted this month with sponsorship from GlaxoSmithKline Consumer Healthcare.

PARSIPPANY, N.J. — Four-in-5 menthol smokers would quit if the Food and Drug Administration banned mentholated cigarettes, according to a survey conducted this month with sponsorship from GlaxoSmithKline Consumer Healthcare.

The survey found that smokers of menthol cigarettes — who are disproportionately African-American — feel “twice-addicted” to the menthol and the tobacco, while 74% of them said the menthol made inhalation easier, and 40% said menthol flavoring was the only reason they smoked.

March 24, 2011

The Consumer Healthcare Products Association may not be painting pink Pepto-Bismol mustaches on a group of Hollywood celebrities and professional athletes as part of the new campaign it plans to fully unveil in June, but the goal is more or less the same as the “Got Milk?” ads.

“Got milk?” has become ubiquitous. There is 100% clarity of message. The milk mustache says it all: Milk is an essential food and an integral part of a healthy diet; it HAS TO BE in your refrigerator, on your breakfast table and in your lunch box.

March 24, 2011

GlaxoSmithKline withdrew all regulatory approval applications for a drug designed to cut men's risk of developing prostate cancer.

LONDON — GlaxoSmithKline withdrew all regulatory approval applications for a drug designed to cut men's risk of developing prostate cancer.

The drug maker announced it no longer would pursue global approval for Avodart (dutasteride) and would work with regulatory agencies to remove the indication from the product’s license.

March 24, 2011

The Food and Drug Administration has approved a topical pain treatment made by Hi-Tech Pharmacal, the drug maker said Thursday.

AMITYVILLE, N.Y. — The Food and Drug Administration has approved a topical pain treatment made by Hi-Tech Pharmacal, the drug maker said Thursday.

The agency approved Hi-Tech’s sterile lidocaine jelly in the 2% strength, used for treating pain in procedures involving the urethra, painful urethritis and in endotracheal intubation.

Various versions of the drug had sales of $17 million in 2010, according to IMS Health.

March 24, 2011

The Food and Drug Administration has approved a generic drug for cardiovascular disease made by Qualitest Pharmaceuticals.

HUNTSVILLE, Ala. — The Food and Drug Administration has approved a generic drug for cardiovascular disease made by Qualitest Pharmaceuticals.

Qualitest announced Thursday the approval of toresmide tablets in the 5-mg, 10-mg, 20-mg and 100-mg strengths.

The drug is used to treat edema associated with congestive heart failure, kidney disease or hepatic disease, and also for hypertension.

March 23, 2011

Though more than 7-in-10 drugs dispensed in the United States today are generics, and the Food and Drug Administration holds generics to the same standards as branded drugs, misgivings among the general public still exist, fed by the occasional media report of patients experiencing bad side effects after taking certain generic drugs.

PITTSBURGH — Though more than 7-in-10 drugs dispensed in the United States today are generics, and the Food and Drug Administration holds generics to the same standards as branded drugs, misgivings among the general public still exist, fed by the occasional media report of patients experiencing bad side effects after taking certain generic drugs.

March 22, 2011

Hi-Tech Pharmacal was granted final approval from the Food and Drug Administration for its treatment of duodenal ulcers.

AMITYVILLE, N.Y. — Hi-Tech Pharmacal was granted final approval from the Food and Drug Administration for its treatment of duodenal ulcers.

The drug maker said its abbreviated new drug application for ranitidine syrup in the 15-mg/mL strength was approved. Ranitidine syrup is a generic version of GlaxoSmithKline’s Zantac syrup, which garnered sales of $21 million for 12 months ended in December 2010, according to IMS sales data.

Hi-Tech currently has 13 products awaiting approval at the FDA, the company said.

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.