Content about Food and Drug Administration

November 21, 2013

The Food and Drug Administration has declined to approve an experimental drug for schizophrenia and bipolar disorder developed by Forest Labs and Gedeon Richter, a Hungarian drug company, the two said Thursday.

NEW YORK — The Food and Drug Administration has declined to approve an experimental drug for schizophrenia and bipolar disorder developed by Forest Labs and Gedeon Richter, a Hungarian drug company, the two said Thursday.

The companies said the FDA issued a complete-response letter for cariprazine. The agency issues a complete-response letter when it has finished reviewing an application but issues remain that preclude final approval. In the letter, the FDA acknowledged the drug's efficacy, but wanted more clinical trial data.

November 20, 2013

Drug maker Perrigo has filed with the Food and Drug Administration for approval of a generic topical ointment for treating acne in adolescents and adults, the company said Wednesday.

ALLEGAN, Mich. — Drug maker Perrigo has filed with the Food and Drug Administration for approval of a generic topical ointment for treating acne in adolescents and adults, the company said Wednesday.

Perrigo said it filed for approval of clindamycin phosphate and benzoyl peroxide gel in the 1.2%/2.5% strengths. The drug is used to treat acne in patients 12 years and older.

November 20, 2013

Following actions by the Food and Drug Administration, USPLabs has agreed to recall and destroy the dietary supplement OxyElite Pro, as it has been linked to dozens of cases of acute liver failure and hepatitis, including one death and illnesses so severe that several patients required liver transplants, the agency noted Wednesday.

SILVER SPRING, Md. — Following actions by the Food and Drug Administration, USPLabs has agreed to recall and destroy the dietary supplement OxyElite Pro, as it has been linked to dozens of cases of acute liver failure and hepatitis, including one death and illnesses so severe that several patients required liver transplants, the agency noted Wednesday. 

November 19, 2013

SILVER SPRING, Md. — At the request of the Food and Drug Administration, U.S. Marshals seized dietary supplements manufactured and held by Hi-Tech Pharmaceuticals, located in Norcross, Ga., after FDA investigators found the products contained 1, 3-Dimethylamylamine HCl (DMAA) or its chemical equivalent, the agency announced Monday.

“This company has a responsibility to ensure its products are safe for distribution and human consumption,” stated Melinda Plaisier, the FDA’s associate commissioner for regulatory affairs. “We have taken action to protect consumers and demonstrate our commitment to their safety by keeping these products from entering the distribution system.”

The retail value of the seized products is more than $2 million, the agency estimated.

A complaint filed in the U.S. District Court for the Northern District of Georgia alleged that the products were adulterated according to the Federal Food, Drug, and Cosmetic Act because they contain DMAA, an unapproved food additive that is deemed unsafe under the law.

The FDA is urging consumers not to buy or use supplements containing DMAA, which can elevate blood pressure and could lead to cardiovascular problems, including heart attack, shortness of breath and tightening of the chest. Given the known biological activity of DMAA, the ingredient may be particularly dangerous when used with caffeine. Consumers should check labels and avoid any dietary supplements containing DMAA, which is referred to on different product labels by 10 possible names. The FDA has warned consumers about the health risks of DMAA on its web site.

On Nov. 12, 2013, U.S. Marshals seized more than 1,500 cases of finished goods and more than 1,200 pounds of in-process/raw material goods from the Hi-Tech Pharmaceuticals facility.

During the FDA’s inspection of Hi-Tech Pharmaceuticals, which began in October, investigators identified 11 products that were labeled as containing DMAA or its chemical equivalent. These products included Black Widow, ECA Xtreme, Fastin, Fastin-XR, Lipodrene, Lipodrene Hardcore, Lipodrene XR, Lipodrene Xtreme, Lipotherm, Stimerex-ES, and Yellow Scorpion. The investigators also observed bulk DMAA raw ingredients at the facility. Prior to the seizure, on Nov. 1, 2013, the FDA issued an administrative detention, temporarily holding the products until they were seized.

Dietary supplements containing DMAA are illegal and the FDA is using all available tools at its disposal to remove these products from the market. In 2012, the FDA issued warning letters to companies notifying them that products containing DMAA need to be taken off the market or reformulated to remove this substance.

SILVER SPRING, Md. — At the request of the Food and Drug Administration, U.S. Marshals seized dietary supplements manufactured and held by Hi-Tech Pharmaceuticals, located in Norcross, Ga., after FDA investigators found the products contained 1, 3-Dimethylamylamine HCl (DMAA) or its chemical equivalent, the agency announced Monday.  

November 18, 2013

Drug maker Actavis hopes to become the first to market with a generic version of a topical testosterone replacement drug marketed by Eli Lilly, Actavis said.

DUBLIN — Drug maker Actavis hopes to become the first to market with a generic version of a topical testosterone replacement drug marketed by Eli Lilly, Actavis said.

The generic drug maker it filed with the Food and Drug Administration for approval of testosterone topical solution in the 30-mg-per-1.5 mL strength, a generic version of Lilly's Axiron. The drug is used as a replacement therapy for deficient or absent testosterone.

November 18, 2013

A bill that would implement federal tracking and tracing of drugs and strengthen federal regulations on pharmacy compounding has passed in the Senate and will go to President Barack Obama for his signature.

NEW YORK — A bill that would implement federal tracking and tracing of drugs and strengthen federal regulations on pharmacy compounding has passed in the Senate and will go to President Barack Obama for his signature.

November 15, 2013

A Food and Drug Administration expert panel has voted to recommend approval for a drug to treat a circadian rhythm disorder that affects most people with total blindness.

WASHINGTON — A Food and Drug Administration expert panel has voted to recommend approval for a drug to treat a circadian rhythm disorder that affects most people with total blindness.

November 15, 2013

The Food and Drug Administration has approved a new drug for fungal infections of the skin made by Valeant Pharmaceuticals International, the drug maker said Friday.

LAVAL, Quebec — The Food and Drug Administration has approved a new drug for fungal infections of the skin made by Valeant Pharmaceuticals International, the drug maker said Friday.

The company announced the FDA approval of Luzu (luliconazole) cream in the 1% strength for treatment of athlete's foot, jock itch and ringworm in adults.

November 15, 2013

The Food and Drug Administration has approved an OTC personal lubricant that helps couples conceive more easily.

CHICAGO — The Food and Drug Administration has approved an OTC personal lubricant that helps couples conceive more easily.

Sasmar announced Friday the FDA approval of Conceive Plus, described as an isotonic, fertility-friendly personal lubricant that helps increase a woman's chances of getting pregnant naturally. The patent-pending formula is pH balanced to mimic fertile fluids and semen and contains minerals helpful to fertilization.

November 15, 2013

The Food and Drug Administration has given orphan drug designation to an experimental treatment for a rare form of epilepsy.

LONDON — The Food and Drug Administration has given orphan drug designation to an experimental treatment for a rare form of epilepsy.

GW Pharmaceuticals said Friday that the FDA had granted the designation to Epidiolex for Dravet syndrome, a severe, drug-resistant form of epilepsy that begins in infancy. The drug is an oral liquid of a highly purified extract of cannabidiol, a non-psychoactive molecule derived from the cannabis plant.

November 15, 2013

The value of drugs approved in the United States this year could reach almost $19 billion in sales five years after their launch, exceeding the value of drugs approved in 2012, according to a new report.

NEW YORK — The value of drugs approved in the United States this year could reach almost $19 billion in sales five years after their launch, exceeding the value of drugs approved in 2012, according to a new report.

November 14, 2013

Drug makers Johnson & Johnson and Pharmacyclics have added Avella Specialty Pharmacy to their limited-distribution network for a newly approved blood cancer drug.

PHOENIX — Drug makers Johnson & Johnson and Pharmacyclics have added Avella Specialty Pharmacy to their limited-distribution network for a newly approved blood cancer drug.

Avella said Thursday that it had joined the limited-distribution network for Imbruvica (ibrutinib), which the Food and Drug Administration approved this week for mantle cell lymphoma. Avella is one of five specialty pharmacies to join the network, the company said.

November 14, 2013

The Food and Drug Administration has requested label and packaging changes of certain over-the-counter topical antiseptic products, according to an FDA MedWatch alert.

SILVER SPRING, Md. — The Food and Drug Administration has requested label and packaging changes of certain over-the-counter topical antiseptic products, according to an FDA MedWatch alert emailed Thursday. "We are requesting that manufacturers package antiseptics indicated for preoperative or preinjection skin preparation in single-use containers," the alert stated. "The antiseptics in these single-use containers should be applied only one time to one patient.

November 13, 2013

The Food and Drug Administration has approved a new drug for treating a rare and aggressive type of blood cancer, the agency said Wednesday.

SILVER SPRING, Md. — The Food and Drug Administration has approved a new drug for treating a rare and aggressive type of blood cancer, the agency said Wednesday.

The FDA announced the approval of Imbruvica (ibrutinib), marketed by Pharmacyclics and Johnson & Johnson, for treating mantle cell lymphoma, or MCL. MCL is a rare form of non-Hodgkin lymphoma and represents about 6% of all non-Hodgkin lymphoma cases in the United States. Millennium Pharmaceuticals' Velcade (bortezomib) and Celgene's Revlimid (lenalidomide) are also approved for treating MCL.

November 13, 2013

The Food and Drug Administration has given special designation to a drug under development by Mast Therapeutics for a rare disease that restricts the flow of blood to the limbs.

SAN DIEGO — The Food and Drug Administration has given special designation to a drug under development by Mast Therapeutics for a rare disease that restricts the flow of blood to the limbs.

November 13, 2013

The chairman of the Senate Health, Education, Labor and Pensions Committee highlighted the human tragedy wrought by last year's fungal meningitis outbreak linked to contaminated injectable steroids as he spoke in favor of a new law that would regulate compounding pharmacies and also implement federal track-and-trace policies for drugs during a recent speech.

WASHINGTON — The chairman of the Senate Health, Education, Labor and Pensions Committee highlighted the human tragedy wrought by last year's fungal meningitis outbreak linked to contaminated injectable steroids as he spoke in favor of a new law that would regulate compounding pharmacies and implement federal track-and-trace policies for drugs during a recent speech.

November 11, 2013

The Food and Drug Administration on Sunday announced that USPlabs of Dallas is recalling certain OxyElite Pro dietary supplement products that the company markets.

SILVER SPRING, Md. — The Food and Drug Administration on Sunday announced that USPlabs of Dallas is recalling certain OxyElite Pro dietary supplement products that the company markets. 

The company took this action after receiving a letter from the FDA stating that the products have been linked to liver illnesses, and that there is a reasonable probability that the products are adulterated.  

November 8, 2013

Sanofi-Aventis has sued the Food and Drug Administration to keep its labeling for OTC Nasacort confidential in an effort to delay store brand competition until after the launch, according to an entry in the FDA Law Blog, the official blog of Hyman, Phelps & McNamara, published Thursday.

WASHINGTON — Sanofi-Aventis has sued the Food and Drug Administration to keep its labeling for OTC Nasacort confidential in an effort to delay store brand competition until after the launch, according to an entry in the FDA Law Blog, the official blog of Hyman, Phelps & McNamara, published Thursday. 

November 8, 2013

The Food and Drug Administration has approved six generic versions of a drug used to treat gastroesophageal reflux disease, or GERD, the agency said Friday.

SILVER SPRING, Md. — The Food and Drug Administration has approved six generic versions of a drug used to treat gastroesophageal reflux disease, or GERD, the agency said Friday.

The FDA announced the approval of the first generic versions of Eisai's Aciphex (rabeprazole sodium) delayed-release tablets for patients aged 12 and older. The generic products are made by Dr. Reddy's Labs, Kremers Urban Pharmaceuticals, Lupin Pharmaceuticals, Mylan Pharmaceuticals, Teva Pharmaceuticals USA and Torrent Pharmaceuticals.

November 8, 2013

The Food and Drug Administration has approved a new drug for treating epileptic seizures, the agency said Friday.

SILVER SPRING, Md. — The Food and Drug Administration has approved a new drug for treating epileptic seizures, the agency said Friday.

The FDA announced the approval of Aptiom (eslicarbazepine acetate), made by Sunovion Pharmaceuticals, as an add-on medication for seizures in adults. About 200,000 new cases of seizures and epilepsy occur in the United States each year, according to the FDA.

November 8, 2013

When the maker of a branded drug updates the safety information on its product labeling, makers of generic versions of that drug must wait until the Food and Drug Administration approves the new labeling before they can update theirs, but that could soon change under a rule proposed by the FDA.

SILVER SPRING, Md. — When the maker of a branded drug updates the safety information on its product labeling, makers of generic versions of that drug must wait until the Food and Drug Administration approves the new labeling before they can update theirs, but that could soon change under a rule proposed by the FDA.

November 8, 2013

A proposed rule from the Food and Drug Administration would effectively eliminate artificial trans fats from foods in the United States by classifying partially hydrogenated oils as unsafe food additives and thus permitting them only in certain cases.

In its proposal, the FDA emphasized that it would give manufacturers of foods that contain trans fats enough time to reformulate their recipes in order to minimize market disruptions by spreading out the initial cost of about $8 billion over a number of years. While trans fats have been eliminated from most foods already, foods that still contain them include frozen pizzas, microwave popcorn, margarines and some dessert foods.

A proposed rule from the Food and Drug Administration would effectively eliminate artificial trans fats from foods in the United States by classifying partially hydrogenated oils as unsafe food additives and thus permitting them only in certain cases.

November 7, 2013

U.S. regulators made a preliminary move Thursday to remove trans fats from food products.

SILVER SPRING, Md. — U.S. regulators made a preliminary move Thursday to remove trans fats from food products.

November 6, 2013

Noven Pharmaceuticals has launched a new drug for severe hot flashes nationwide, the company said.

NEW YORK — Noven Pharmaceuticals has launched a new drug for severe hot flashes nationwide, the company said.

The drug maker announced the availability of Brisdelle (paroxetine) capsules in the 7.5-mg strength, the first-ever non-hormonal drug approved by the Food and Drug Administration for moderate to severe hot flashes associated with menopause.

November 5, 2013

The Food and Drug Administration has approved a generic injectable antibiotic drug made by Emcure Pharmaceuticals, according to the agency.

SILVER SPRING, Md. – The Food and Drug Administration has approved a generic injectable antibiotic drug made by Emcure Pharmaceuticals, according to the agency.

The FDA approved Emcure's vancomycin hydrochloride injection in the 5-g-per-vial strength.

The drug is a generic version of Vancocin, made by ViroPharma.