Content about Maryland

December 1, 2011
FDA issues draft guidance to investigators, manufacturers of artificial pancreas systems

In an effort to help advance the development of devices that automatically monitor blood glucose and provide proper insulin doses in people with Type 1 diabetes, the Food and Drug Administration has issued draft guidance to help investigators and manufacturers as they develop and seek approval for these products.

SILVER SPRING, Md. — In an effort to help advance the development of devices that automatically monitor blood glucose and provide proper insulin doses in people with Type 1 diabetes, the Food and Drug Administration has issued draft guidance to help investigators and manufacturers as they develop and seek approval for these products.

December 1, 2011
Ranbaxy launches generic Lipitor

Ranbaxy Labs got the green light from the Food and Drug Administration Wednesday night to launch its generic version of Pfizer's cholesterol-lowering drug Lipitor.

SILVER SPRING, Md. — Ranbaxy Labs got the green light from the Food and Drug Administration Wednesday night to launch its generic version of Pfizer's cholesterol-lowering drug Lipitor.

The FDA announced the approval of Ranbaxy's atorvastatin calcium tablets in the 10-mg, 20-mg, 40-mg and 80-mg strengths. New Brunswick, N.J.-based Ohm Labs will manufacture the drug.

November 28, 2011
FDA files permanent injunction against ATF Fitness Products

The Food and Drug Administration last week took legal action against the dietary supplement manufacturer ATF Fitness Products for substituting ingredients and products without noting the changes on the final product labels.

SILVER SPRING, Md. — The Food and Drug Administration last week took legal action against the dietary supplement manufacturer ATF Fitness Products for substituting ingredients and products without noting the changes on the final product labels.

The permanent injunction, filed on behalf of the FDA by the U.S. Department of Justice, would stop the defendants from making and distributing more than 400 products for being in violation of the Federal Food, Drug and Cosmetic Act. Brands include Sci-Fit, Nature's Science and For Store Only.

November 28, 2011
Harris Teeter to open Baltimore store

Harris Teeter will open a 61,000-sq.-ft. store in Baltimore, making it the chain's first in the city and seventh in Maryland.

CHARLOTTE, N.C. — Harris Teeter will open a 61,000-sq.-ft. store in Baltimore, making it the chain's first in the city and seventh in Maryland.

The store, which will be located in the McHenry Row neighborhood of Baltimore, opens its doors on Dec. 7. The supermarket places strong emphasis on fresh foods, items-to-go and perishable items, Harris Teeter said.

The chain also is applying for LEED certification for the location, noting the supermarket will include electric vehicle charging stations and an integrated refrigeration.

November 23, 2011
FDA approves first drug for insomnia with middle-of-night waking, difficulty returning to sleep

The Food and Drug Administration has approved the first drug for insomnia in which patients wake in the middle of the night and have trouble returning to sleep.

SILVER SPRING, Md. — The Food and Drug Administration has approved the first drug for insomnia in which patients wake in the middle of the night and have trouble returning to sleep.

November 22, 2011
UnitedHealthcare acquires XLHealth

A UnitedHealth Group company announced its plans to acquire a sponsor of Medicare Advantage health plans in an all-cash transaction.

MINNETONKA, Minn. — A UnitedHealth Group company announced its plans to acquire a sponsor of Medicare Advantage health plans in an all-cash transaction.

November 18, 2011
FDA approves Erwinaze for acute lymphoblastic leukemia

The Food and Drug Administration has approved a new chemotherapy drug for treating acute lymphoblastic leukemia, the agency said Friday.

SILVER SPRING, Md. — The Food and Drug Administration has approved a new chemotherapy drug for treating acute lymphoblastic leukemia, the agency said Friday.

The FDA announced the approval of EUSA Pharma's Erwinaze (asparaginase Erwinia chrysanthemi) to treat patients with ALL who have developed an allergy to E. coli-derived asparaginase and pegaspargase chemotherapy drugs.

November 18, 2011
FDA revokes breast cancer approval for Avastin

A drug widely used to treat breast cancer is not safe or effective, the Food and Drug Administration said Friday.

SILVER SPRING, Md. — A drug widely used to treat breast cancer is not safe or effective, the Food and Drug Administration said Friday.

November 16, 2011
FDA approves drug for rare bone marrow disorder

The Food and Drug Administration has approved a new drug for treating a rare bone disease, the agency said Wednesday.

SILVER SPRING, Md. — The Food and Drug Administration has approved a new drug for treating a rare bone marrow disease, the agency said Wednesday.

November 8, 2011
FDA develops Web resource outlining proper sharps disposal

The Food and Drug Administration on Tuesday launched a website for patients and caregivers on the safe disposal of needles and other “sharps” that are used at home, at work and while traveling.

SILVER SPRING, Md. — The Food and Drug Administration on Tuesday launched a website for patients and caregivers on the safe disposal of needles and other “sharps” that are used at home, at work and while traveling.

November 7, 2011
FDA appoints new commissioner's chief of staff

The Food and Drug Administration has appointed a new chief of staff for commissioner Margaret Hamburg, according to a letter sent to agency employees Monday.

SILVER SPRING, Md. — The Food and Drug Administration has appointed a new chief of staff for commissioner Margaret Hamburg, according to a letter sent to agency employees Monday.

In the letter, Hamburg announced the appointment of Lisa Barclay. Barclay, currently a partner at the Washington law firm Zuckerman Spaeder, will replace Molly Muldoon, who was previously chief of staff and more recently the agency's acting COO.

November 7, 2011
FDA approves J&J's Xarelto for stroke prevention

The Food and Drug Administration has approved a drug made by Johnson & Johnson for preventing stroke in patients with abnormal heart rhythm, the agency said.

SILVER SPRING, Md. — The Food and Drug Administration has approved a drug made by Johnson & Johnson for preventing stroke in patients with abnormal heart rhythm, the agency said.

The agency announced Friday the approval of Xarelto (rivaroxaban), an anti-clotting made by J&J subsidiary Janssen Pharmaceuticals, in patients with non-valvular atrial fibrillation. The FDA approved the drug in the 10-mg strength in July for deep-vein thrombosis in patients receiving knee and hip replacement surgery. The latest approval includes 15-mg and 20-mg strengths.

November 7, 2011
FDA gives new approval to Bristol-Myers Squibb's, Lilly's Erbitux

The Food and Drug Administration has approved a drug made by Bristol-Myers Squibb for treating head and neck cancer, the agency said Monday.

SILVER SPRING, Md. — The Food and Drug Administration has approved a drug made by Bristol-Myers Squibb and Eli Lilly & Co. for treating head and neck cancer, the agency said Monday.

The FDA announced the approval of Erbitux (cetuximab) for use with chemotherapy in treating head and neck cancer that had spread to other parts of the body. The drug originally was approved in 2004 for treating certain cases of late-stage colon cancer in patients who had stopped responding to chemotherapy.

November 3, 2011
FDA report: 35 new drugs approved in past year

The Food and Drug Administration has approved 35 new drugs over the past 12 months, the agency said Thursday.

SILVER SPRING, Md. — The Food and Drug Administration has approved 35 new drugs over the past 12 months, the agency said Thursday.

November 2, 2011
CareFirst BlueCross BlueShield, Cardinal Health develop clinical pathways program for RA

CareFirst BlueCross BlueShield and Cardinal Health Specialty Solutions on Tuesday launched the nation's first clinical pathways program for rheumatoid arthritis, a chronic disease that leads to inflammation of the joints and surrounding tissue and affects nearly 2.1 million Americans each year.

BALTIMORE — CareFirst BlueCross BlueShield and Cardinal Health Specialty Solutions on Tuesday launched the nation's first clinical pathways program for rheumatoid arthritis, a chronic disease that leads to inflammation of the joints and surrounding tissue and affects nearly 2.1 million Americans each year.

November 2, 2011
Report: Meth cooks credited with 80% increase in PSE sales

There has been a sharp increase in sales of pseudoephedrine products just outside St. Charles County, Mo., which implemented a prescription requirement on the sale of PSE beginning Aug. 30, according to an article in the St. Louis Post-Dispatch published Monday.

ST. LOUIS — There has been a sharp increase in sales of pseudoephedrine products just outside St. Charles County, Mo., which implemented a prescription requirement on the sale of PSE beginning Aug. 30, according to an article in the St. Louis Post-Dispatch published Monday that cited data from Det. Sgt. Jason Grellner, past president of the Missouri Narcotics Officers Association.

According to that data, sales of PSE products were up 81% in September versus August in Bridgeton, Mo., and increases in Maryland Heights and Chesterfield were 59% and 51%, respectively.

October 31, 2011
Report: Catalyst Rx case study justifies Walgreens PBM network inclusion

Catalyst Rx, the pharmacy benefits management subsidiary of Catalyst Health Solutions, on Friday took out a full-page ad in the Wall Street Journal touting the value of a Walgreens pharmacy to a large healthcare payer. Catalyst also released a case study touting that value, according to a DrugChannels.net report.

ROCKVILLE, Md. — Catalyst Rx, the pharmacy benefits management subsidiary of Catalyst Health Solutions, on Friday took out a full-page ad in the Wall Street Journal touting the value of a Walgreens pharmacy to a large healthcare payer. Catalyst also released a case study touting that value, according to a DrugChannels.net report.

October 24, 2011
FDA approves drug for severe epilepsy

The Food and Drug Administration has approved a new drug for treating a severe form of epilepsy, the agency said Monday.

SILVER SPRING, Md. — The Food and Drug Administration has approved a new drug for treating a severe form of epilepsy, the agency said Monday.

The FDA announced the approval of Onfi (clobazam) tablets, made by Catalent Pharma Solutions and Lundbeck, as an add-on treatment for seizures associated with Lennox-Gastaut syndrome in patients ages 2 years and older. The agency gave the drug orphan drug designation because the disease affects fewer than 200,000 people in the United States.

October 24, 2011
FDA approves generic versions of Zyprexa

The Food and Drug Administration has approved the first generic versions of two drugs made by Eli Lilly for treating schizophrenia and bipolar disorder, the agency said Monday.

SILVER SPRING, Md. — The Food and Drug Administration has approved the first generic versions of two drugs made by Eli Lilly for treating schizophrenia and bipolar disorder, the agency said Monday.

The FDA announced the approval of generic olanzapine tablets and olanzapine orally disintegrating tablets, respectively generic versions of Lilly's Zyprexa and Zyprexa Zydus. Dr. Reddy's Labs and Teva Pharmaceuticals USA will manufacture olanzapine tablets, while Dr. Reddy's, Apotex and Par Pharmaceuticals will manufacture the orally disintegrating version.

October 14, 2011
Endocrine Society releases recommendations for continuous glucose monitoring

Patients with diabetes may benefit from a system that provides continuous, real-time glucose readings, according to new clinical practice guidelines released by the Endocrine Society.

CHEVY CHASE, Md. — Patients with diabetes may benefit from a system that provides continuous, real-time glucose readings, according to new clinical practice guidelines released by the Endocrine Society.

While most patients with diabetes measure blood glucose by pricking their skin to get a drop of blood and then measuring it with a glucose meter, continuous glucose monitoring measures glucose in the interstitial fluid, the fluid between cells just under the skin.

October 14, 2011
FDA approves treatment for iron overload

The Food and Drug Adminsitration has approved a drug made by ApoPharma for a complication resulting from treatments for a genetic condition that causes anemia, the agency said Friday.

SILVER SPRING, Md. — The Food and Drug Adminsitration has approved a drug made by ApoPharma for a complication resulting from treatments for a genetic condition that causes anemia, the agency said Friday.

The FDA announced the approval of Ferriprox (deferiprone), used to treat patients with iron overload due to blood transfusions for thalassemia, a blood disorder. Patients with the disease have excess iron in their bodies because of the frequent blood transfusions they must receive that can lead to iron overload, a condition that can be fatal.

October 12, 2011
NIH study links vitamin E supplementation to prostate cancer

A National Institutes of Health study published Tuesday in the Journal of the American Medical Association established a link between vitamin E supplementation and prostate cancer.

BETHESDA, Md. — A National Institutes of Health study published Tuesday in the Journal of the American Medical Association established a link between vitamin E supplementation and prostate cancer. Men who took 400 international units of vitamin E daily had more prostate cancers compared with men who took a placebo, according to an updated review of data from the Selenium and Vitamin E Cancer Prevention Trial, the NIH stated.

October 10, 2011
Giant-Carlisle to donate to breast cancer groups

Giant Food Stores is marking National Breast Cancer Awareness Month by donating more than $25,000 to organizations that address the disease, the Royal Ahold-owned supermarket chain said.

CARLISLE, Pa. — Giant Food Stores is marking National Breast Cancer Awareness Month by donating more than $25,000 to organizations that address the disease, the Royal Ahold-owned supermarket chain said.

October 7, 2011
Merck's Juvisync approved for Type 2 diabetes, high cholesterol

The Food and Drug Administration has approved a drug that it called the first single-pill combination treatment for Type 2 diabetes and high cholesterol.

SILVER SPRING, Md. — The Food and Drug Administration has approved a drug that it called the first single-pill combination treatment for Type 2 diabetes and high cholesterol.

The FDA approved Merck's Juvisync (sitagliptin and simvastatin), manufactured by Merck subsidiary MSD International GmbH Clonmel Co., based in Tipperary, Ireland. Merck operates under the name MSD outside the United States and Canada in order to avoid confusion with Germany-based Merck KGaA.

October 3, 2011
Coventry Health Care unveils Walgreens, Walmart, Target Medicare plan network

Coventry Health Care on Saturday announced that it has partnered with Walgreens, Walmart and Target for 2012 to offer a Medicare prescription drug plan known as First Health Value Plus.

BETHESDA, Md. — Coventry Health Care on Saturday announced that it has partnered with Walgreens, Walmart and Target for 2012 to offer a Medicare prescription drug plan known as First Health Value Plus.

As Coventry’s newest Medicare Prescription Drug Plan, First Health Value Plus is the lowest premium, zero-dollar deductible Part D plan in the United States, the company stated.