Content about Regulatory and Washington

November 13, 2013

As cold and flu season kicks into high gear, the Acetaminophen Awareness Coalition on Tuesday issued a nationwide safety message urging consumers to double-check their medicine labels so they don’t double-up on medicines that contain acetaminophen when treating winter illnesses.

WASHINGTON — As cold and flu season kicks into high gear, the Acetaminophen Awareness Coalition on Tuesday issued a nationwide safety message urging consumers to double-check their medicine labels so they don’t double-up on medicines that contain acetaminophen when treating winter illnesses. 

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

Greater use of statins in reducing the risk of high cholesterol is among the long-awaited new guidelines for treating lipid and weight disorders.

WASHINGTON — Greater use of statins in reducing the risk of high cholesterol is among the long-awaited new guidelines for treating lipid and weight disorders.

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 12, 2013

According to an article published in Annals of Internal Medicine Monday, a systematic review of published studies found insufficient evidence that vitamin and mineral supplements are effective for preventing cardiovascular disease, cancer or mortality from those diseases in healthy adults.

PHILADELPHIA — According to an article published in Annals of Internal Medicine Monday, a systematic review of published studies found insufficient evidence that vitamin and mineral supplements are effective for preventing cardiovascular disease, cancer or mortality from those diseases in healthy adults. 

November 11, 2013

Customers of Amazon living in New York and Los Angeles can get their packages delivered on Sundays, courtesy of the U.S. Postal Service.

SEATTLE — Customers of Amazon living in New York and Los Angeles can get their packages delivered on Sundays, courtesy of the U.S. Postal Service.

The online retailer announced the new service Monday, directed at members of the premium Amazon Prime service living in the New York and Los Angeles areas. Next year, the retailer will also roll it out to members in Dallas, Houston, New Orleans, Phoenix and other cities.

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 11, 2013

The Specialty Pharmacy Certification Board has certified nearly 50 pharmacists following the first round of exams, the group said Monday.

ALEXANDRIA, Va. — The Specialty Pharmacy Certification Board has certified nearly 50 pharmacists following the first round of exams, the group said Monday.

The SPCB announced that 49 pharmacists had earned the Certified Specialty Pharmacist accreditation after taking the exams, which were administered in October, covering intake, fulfillment, clinical management and outcomes.

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

Boehringer Ingelheim SVP managed markets Jeff Huth has been elected by the National Pharmaceutical Council as chairman of the board for 2013-2014, the organization said Friday.

WASHINGTON — Boehringer Ingelheim SVP managed markets Jeff Huth has been elected by the National Pharmaceutical Council as chairman of the board for 2013-2014, the organization said Friday.

Huth has served as a member of the NPC's board since 2009 and has previously had the positions of vice chairman and treasurer. The NPC, founded in 1953, describes itself as a health policy research organization focused on the advancement of science and medical innovation.

November 8, 2013

The retail industry added 37,600 jobs in October, and 295,000 year-over-year, according to a new report by a retail industry trade group.

WASHINGTON — The retail industry added 37,600 jobs in October, and 295,000 year-over-year, according to a new report by a retail industry trade group.

Analysing numbers from the Bureau of Labor Statistics, the National Retail Federation said the increase represented 2.4% boost over 2012, and every sector of retail added jobs except clothing retailers, which lost 12,500 jobs. Overall, according to the BLS, the economy added 204,000 jobs in October, and the unemployment rate was 7.3%.

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 7, 2013

A former executive from Cisco has been appointed as CEO of the International Diabetes Federation.

BRUSSELS — A former executive from Cisco has been appointed as CEO of the International Diabetes Federation.

The IDF announced Thursday the appointment of Petra Wilson, who formerly served as Cisco's senior director of the European health and care business solutions team, working with the World Health Organization, the European Commission, governments and others.

November 7, 2013

New Senate legislation introduced Tuesday that would restore consumers’ ability to use pre-tax dollars from flexible spending accounts and health savings accounts to purchase over-the-counter medicines without first seeing a doctor has been jointly endorsed by the National Association of Chain Drug Stores and the National Community Pharmacists Association.

ALEXANDRIA, Va. — New Senate legislation introduced Tuesday that would restore consumers’ ability to use pre-tax dollars from flexible spending accounts and health savings accounts to purchase over-the-counter medicines without first seeing a doctor has been jointly endorsed by the National Association of Chain Drug Stores and the National Community Pharmacists Association. 

November 7, 2013

Sen. David Vitter, R-La., is holding up a vote on a measure that would strengthen regulations on compounding pharmacies in order to alter a provision of the Patient Protection and Affordable Care Act, according to published reports.

NEW YORK — Sen. David Vitter, R-La., is holding up a vote on a measure that would strengthen regulations on compounding pharmacies in order to alter a provision of the Patient Protection and Affordable Care Act, according to published reports.

November 6, 2013

U.S. Sens. Pat Roberts, R-Kan., and Mary Landrieu, D-La., on Tuesday introduced legislation that repeals a portion of Obamacare that prohibits people from using their medical savings account funds to buy over-the-counter medications.

WASHINGTON — U.S. Sens. Pat Roberts, R-Kan., and Mary Landrieu, D-La., on Tuesday introduced legislation that repeals a portion of Obamacare that prohibits people from using their medical savings account funds to buy over-the-counter medications. Under current law, plan participants may no longer use funds from these accounts to purchase OTC medications, unless they have a prescription for the medication.

November 6, 2013

State legislators in Michigan are considering a bill that would allow pharmacies to sell medical marijuana, according to published reports.

NEW YORK — State legislators in Michigan are considering a bill that would allow pharmacies to sell medical marijuana, according to published reports.

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.

 

November 5, 2013

The Food and Drug Administration has approved a generic drug made by Mylan for treating overactive bladder, according to agency records.

SILVER SPRING, Md. — The Food and Drug Administration has approved a generic drug made by Mylan for treating overactive bladder, according to agency records.

The FDA approved Mylan's tolterodine tartrate extended-release capsules in the 2-mg and 4-mg strengths.

The drug is a generic version of Pfizer's Detrol LA. Detrol LA has annual sales of about $700 million, according to published reports.

 

November 4, 2013

The Food and Drug Administration has approved a new injectable painkiller made by Becton, Dickinson and Co., the medical products manufacturer said Monday.

FRANKLIN LAKES, N.J. — The Food and Drug Administration has approved a new injectable painkiller made by Becton, Dickinson and Co., the medical products manufacturer said Monday.

BD announced the FDA approval of morphine sulfate injection as part of its BD Simplist line of ready-to-administer pre-filled injectables. The drug was approved in the 2-mg-per-mL, 4-mg-per-mL, 5-mg-per-mL, 8-mg-per-mL and 10-mg-per-mL strengths.

November 4, 2013

The Food and Drug Administration has asked Ariad Pharmaceuticals to suspend marketing and sales of a chemotherapy drug for leukemia due to the risk of life-threatening side effects, the agency said.

SILVER SPRING, Md. — The Food and Drug Administration has asked Ariad Pharmaceuticals to suspend marketing and sales of a chemotherapy drug for leukemia due to the risk of life-threatening side effects, the agency said.