Content about Maryland

January 27, 2012

The Food and Drug Administration has approved a drug made by Pfizer for treating advanced kidney cancer, the agency said Friday.

SILVER SPRING, Md. — The Food and Drug Administration has approved a drug made by Pfizer for treating advanced kidney cancer, the agency said Friday.

The FDA announced the approval of Inlyta (axitinib) for patients with advanced kidney cancer, also known as renal cell carcinoma, who have not responded to another drug for the disease. The drug, a twice-daily pill, works by blocking certain proteins called kinases that are involved with tumor growth and disease progression.

January 26, 2012

Drug maker Amgen is acquiring a Rockville, Md.-based company developing therapies for cancer, the companies said Thursday.

THOUSAND OAKS, Calif. — Drug maker Amgen is acquiring a Rockville, Md.-based company developing therapies for cancer, the companies said Thursday.

Amgen announced plans to buy Micromet for $1.16 billion, or $11 per share. Micromet, originally founded in Germany, is developing blinatumomab, currently in phase-2 trials as a treatment for acute lymphoblastic leukemia and non-Hodgkin's lymphoma. The acquisition also will include the company's research and development center in Munich.

January 19, 2012

Shoppers Food and Pharmacy, a Supervalu banner, is encouraging consumers to eat healthy by expanding its in-store nutritional navigation program.

BOWIE, Md. — Shoppers Food and Pharmacy, a Supervalu banner, is encouraging consumers to eat healthy by expanding its in-store nutritional navigation program.

Shoppers said that Nutrition iQ now will include the fresh food department, robust nutrition information for the center store, including additional signage, nutritional attributes and health benefit information, to help consumers identify better-for-you foods.

January 16, 2012

The Food and Drug Administration's latest message to consumers and healthcare professionals seems like a no-brainer: "Insulin pens are not for sharing."

SILVER SPRING, Md. — The Food and Drug Administration's latest message to consumers and healthcare professionals seems like a no-brainer: "Insulin pens are not for sharing."

But the agency said it knew of two undisclosed hospitals that it said had reused the cartridge components of insulin pens in administering insulin to more than 2,000 patients, though the hospitals reportedly changed the pens themselves.

January 12, 2012

The U.S. division of Delhaize Group is looking to strengthen its position in the market by retiring one of its supermarket banners and closing several underperforming stores.

SALISBURY, N.C. — The U.S. division of Delhaize Group is looking to strengthen its position in the market by retiring one of its supermarket banners and closing several underperforming stores.

Delhaize America announced that it will retire its Bloom banner, which operates stores in Virginia and Maryland. Additionally, Delhaize America will close 126 underperforming stores, including 113 stores under the Food Lion banner, seven stores under the Bloom banner and six under the Bottom Dollar Food banner.

January 4, 2012

Nutramax Labs on Tuesday announced the continuation of its partnership with Major League Baseball's Hall of Fame pitcher Jim Palmer in promoting Cosamin joint health supplements in national and regional marketing campaigns and events.

EDGEWOOD, Md. — Nutramax Labs on Tuesday announced the continuation of its partnership with Major League Baseball's Hall of Fame pitcher Jim Palmer in promoting Cosamin joint health supplements in national and regional marketing campaigns and events.

“We are pleased to enter into our 12th year of partnership with Jim Palmer,” stated Troy Henderson, VP corporate operations and professional services. "Palmer is an excellent [spokesman] for Cosamin joint health supplements because Cosamin is not just for athletes, but for anyone who is active.”

January 3, 2012

The Food and Drug Administration is streamlining the enrollment process for risk evaluation and mitigation strategies for a class of painkillers, the agency said Tuesday.

SILVER SPRING, Md. — The Food and Drug Administration is streamlining the enrollment process for risk evaluation and mitigation strategies for a class of painkillers, the agency said Tuesday.

December 23, 2011

The Food and Drug Administration on Thursday urged consumers to carefully read the labels of liquid acetaminophen marketed for infants to avoid giving the wrong dose to their infants.

SILVER SPRING, Md. — The Food and Drug Administration on Thursday urged consumers to carefully read the labels of liquid acetaminophen marketed for infants to avoid giving the wrong dose to their infants. Giving more than the recommended dose of acetaminophen can cause serious side effects and possibly death, the agency warned.

December 21, 2011

The Food and Drug Administration has approved an HIV drug for children and adolescents, the agency said Wednesday.

SILVER SPRING, Md. — The Food and Drug Administration has approved an HIV drug for children and adolescents, the agency said Wednesday.

The FDA announced the approval of Merck's Isentress (raltegravir) for HIV-1 infection in patients ages 2 to 18 years. The chewable form of the drug will be available for children ages 2 to 11 years.

"Many young children and adolescents are living with HIV, and this approval provides an important additional option for their treatment," FDA Office of Antimicrobial Products director Edward Cox said.

 

December 21, 2011

Ranbaxy Labs said Wednesday that it had resolved long-standing issues concerning two of its manufacturing plants in India with the U.S. government.

GURGAON, India — Ranbaxy Labs said Wednesday that it had resolved long-standing issues concerning two of its manufacturing plants in India with the U.S. government.

December 19, 2011

The Food and Drug Administration has approved a drug for treating high blood pressure made by Mylan, FDA records showed.

SILVER SPRING, Md. — The Food and Drug Administration has approved a drug for treating high blood pressure made by Mylan, FDA records showed.

The FDA approved Mylan's metoprolol succinate tablets in the 25-mg, 50-mg, 100-mg and 200-mg strengths.

The drug is a generic version of AstraZeneca's Toprol-XL.

December 8, 2011

A recent study of obese and nonobese children found that low vitamin D levels are significantly more prevalent in obese children and are associated with risk factors for Type 2 diabetes.

CHEVY CHASE, Md. — A recent study of obese and nonobese children found that low vitamin D levels are significantly more prevalent in obese children and are associated with risk factors for Type 2 diabetes. This study was accepted for publication in the Endocrine Society’s Journal of Clinical Endocrinology & Metabolism.

December 7, 2011

Prescribers, patients and specialty care centers no longer will be required to enroll in safety monitoring programs for two drugs used to treat low platelet counts, following changes to their risk evaluation and mitigation strategies.

SILVER SPRING, Md. — Prescribers, patients and specialty care centers no longer will be required to enroll in safety monitoring programs for two drugs used to treat low platelet counts, following changes to their risk evaluation and mitigation strategies.

December 7, 2011

At the request of the Food and Drug Administration, U.S. marshals on Tuesday seized raw materials imported by Infinity Marketing Group containing ephedrine alkaloids, a large family of pharmacological compounds called sympathomimetics that have been banned by the FDA for use in dietary supplements since 2004.

SILVER SPRING, Md. — At the request of the Food and Drug Administration, U.S. marshals on Tuesday seized raw materials imported by Infinity Marketing Group containing ephedrine alkaloids, a large family of pharmacological compounds called sympathomimetics that have been banned by the FDA for use in dietary supplements since 2004.

The seizure took place in Rancho Dominguez, Calif. Through this action, FDA removed more than $70,000 worth of dietary supplement ingredients from the market.

December 7, 2011

Food and Drug Administration commissioner Margaret Hamburg on Wednesday issued a public statement that the agency was prepared to approve Plan B as a nonprescription medication, but reversed that decision following a directive from the Department of Health and Human Services Wednesday morning.

SILVER SPRING, Md. — Food and Drug Administration commissioner Margaret Hamburg on Wednesday issued a public statement that the agency was prepared to approve Plan B as a nonprescription medication, but reversed that decision following a directive from the Department of Health and Human Services Wednesday morning.

December 6, 2011

The Food and Drug Administration and the Federal Trade Commission on Tuesday issued seven warning letters to companies marketing over-the counter human chorionic gonadotropin products that are labeled as "homeopathic" for weight loss.

SILVER SPRING, Md. — The Food and Drug Administration and the Federal Trade Commission on Tuesday issued seven warning letters to companies marketing over-the counter human chorionic gonadotropin products that are labeled as "homeopathic" for weight loss. The letters warn the companies that they are violating federal law by selling drugs that have not been approved and by making unsupported claims for the substances. There are no FDA-approved HCG drug products for weight loss.

December 1, 2011

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 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

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 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

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

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

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

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

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.