Content about Maryland

November 13, 2013

AstraZeneca specialty drugs division MedImmune will work with author Elizabeth Pantley to publish a new guide designed to educate parents on flu prevention.

GAITHERSBURG, Md. — AstraZeneca specialty drugs division MedImmune will work with author Elizabeth Pantley to publish a new guide designed to educate parents on flu prevention.

MedImmune said Wednesday a partnership with Pantley, author of the No-Cry Solution parenting book series, to publish "A Parent's Guide to Flu Season." The guide is designed to educate parents on the importance of flu prevention and help them navigate through flu myths and misconceptions.

November 12, 2013

Supermarket chain Giant Food of Landover, Md., has started a new way for non-profit organizations to use its gift cards to raise money.

LANDOVER, Md. — Supermarket chain Giant Food of Landover, Md., has started a new way for non-profit organizations to use its gift cards to raise money.

Giant-Landover announced the launch of "Ca$h for Causes," whereby non-profits can purchase at least $500 worth of Giant gift cards at a 5% discount and then sell them at face value.

November 12, 2013

Laboratory sciences company Waters Corp. has recognized the University of Maryland School of Pharmacy's Department of Pharmaceutical Sciences' mass spectrometry facility as the first to receive its Waters Centers of Innovation honors, the company announced at a ceremony Tuesday.

MILFORD, Mass. — Laboratory sciences company Waters Corp. has recognized the University of Maryland School of Pharmacy's Department of Pharmaceutical Sciences' mass spectrometry facility as the first to receive its Waters Centers of Innovation honors, the company announced at a ceremony Tuesday.

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

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 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 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 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.

November 1, 2013

The Food and Drug Administration has approved a new drug for leukemia made by Genentech, the agency said Friday.

SILVER SPRING, Md. — The Food and Drug Administration has approved a new drug for leukemia made by Genentech, the agency said Friday.

The FDA announced the approval of Gazyva (obinutuzumab) for treating patients with previously untreated chronic lymphocytic leukemia, in combination with the chemotherapy drug chlorambucil. The drug works by helping certain cells in the immune system attack cancer cells.

November 1, 2013

Ahold USA has appointed a former executive for Asian retailer Dairy Farm International as president of its Giant Food of Landover, Md., division, Ahold said Friday.

CARLISLE, Pa. – Ahold USA has appointed a former executive for Asian retailer Dairy Farm International as president of its Giant Food of Landover, Md., division, Ahold said Friday.

October 31, 2013

The Food and Drug Administration is using long-term strategies to address drug shortages when they appear and requiring manufacturers to notify the agency if a shortage is at risk of happening, under a new plan announced Thursday.

SILVER SPRING, Md. — The Food and Drug Administration is using long-term strategies to address drug shortages when they appear and requiring manufacturers to notify the agency if a shortage is at risk of happening, under a new plan announced Thursday.

October 31, 2013

Earlier this year, the Food and Drug Administration approved a new drug for treating cystic fibrosis for patients who have a specific genetic mutation, but that also treats the underlying cause of the disease rather than the disease itself.

SILVER SPRINGS, Md. — Earlier this year, the Food and Drug Administration approved a new drug for treating cystic fibrosis for patients who have a specific genetic mutation, but that also treats the underlying cause of the disease rather than the disease itself.

October 28, 2013

The Food and Drug Administration has launched an online learning course aimed at healthcare professionals to educate them about potentially untruthful or misleading drug ads and promotional materials.

SILVER SPRING, Md. — The Food and Drug Administration has launched an online learning course aimed at healthcare professionals to educate them about potentially untruthful or misleading drug ads and promotional materials.

October 25, 2013

The Food and Drug Administration has approved a new opioid painkiller made by Zogenix, the agency said Friday.

SILVER SPRING, Md. — The Food and Drug Administration has approved a new opioid painkiller made by Zogenix, the agency said Friday.

The FDA announced the approval of Zohydro ER (hydrocodone) extended-release capsules for the management of pain severe enough to require daily, around-the-clock, long-term treatment. The agency said the drug was the first extended-release hydrocodone product not combined with another drug, such as acetaminophen, to be approved by the agency.

October 25, 2013

The Food and Drug Administration plans to recommend stronger regulations for a commonly used opioid painkiller.

SILVER SPRING, Md. — The Food and Drug Administration plans to recommend stronger regulations for a commonly used opioid painkiller.

October 25, 2013

According to a Herald-Mail Media report published Thursday, Walgreens is set to acquire five Home Care pharmacies operated by hospital system Meritus Health within the next six weeks.

HAGERSTOWN, Md. — According to a Herald-Mail Media report published Thursday, Walgreens is set to acquire five Home Care pharmacies operated by hospital system Meritus Health within the next six weeks. 

October 23, 2013

The Food and Drug Administration plans to complete its phase out of inhalers that contain ozone-depleting chlorofluorocarbons by the end of the year, the agency said Wednesday.

SILVER SPRING, Md. — The Food and Drug Administration plans to complete its phase out of inhalers that contain ozone-depleting chlorofluorocarbons by the end of the year, the agency said Wednesday.

October 23, 2013

The University of Maryland's School of Pharmacy has named its atrium in honor of a graduate who now leads an institutional pharmacy services company.

BALTIMORE — The University of Maryland's School of Pharmacy has named its atrium in honor of a graduate who now leads an institutional pharmacy services company.

October 22, 2013

The Food and Drug Administration has approved a generic contraceptive drug made by Famy Care, agency records show.

SILVER SPRING, Md. — The Food and Drug Administration has approved a generic contraceptive drug made by Famy Care, agency records show.

The agency approved Famy's levonorgestrel and ethinyl estradiol tablets in the 0.02-mg/0.1-mg strengths.

The drug is a generic version of Aviane-28, made by Teva Women's Health, a division of Israeli drug maker Teva Pharmaceutical Industries that previously went under the name Duramed.

 

October 22, 2013

The Food and Drug Administration has approved a new generic drug for treating bacterial and protozoan infections, according to the agency.

SILVER SPRING, Md. — The Food and Drug Administration has approved a new generic drug for treating bacterial and protozoan infections, according to the agency.

The FDA approved a generic version of Mission Pharmacal's Tindamax (tinidazole) made by Unique Pharmaceuticals. The drug is a tablet in the 250-mg and 500-mg strengths.

Tindamax is used to treat bacterial vaginosis, trichomoniasis and giardiasis. The drug has annual sales of about $16.2 million, according to IMS Health.

 

October 22, 2013

The Food and Drug Administration, in a complaint filed by the U.S. Department of Justice, on Monday sought a permanent injunction against the dietary supplement manufacturer James G. Cole; its president, James Cole; and its general manager, Julie Graves, following the company’s repeated distribution of unapproved drugs and adulterated dietary supplements in violation of the Federal Food, Drug and Cosmetic Act.

SILVER SPRING, Md. — The Food and Drug Administration, in a complaint filed by the U.S. Department of Justice, on Monday sought a permanent injunction against the dietary supplement manufacturer James G. Cole; its president, James Cole; and its general manager, Julie Graves, following the company’s repeated distribution of unapproved drugs and adulterated dietary supplements in violation of the Federal Food, Drug and Cosmetic Act.

October 22, 2013

Researchers have begun the first definitive, large-scale clinical trial to investigate if a vitamin D supplement helps prevent or delay Type 2 diabetes in adults who have prediabetes and are at high risk for developing Type 2.

BETHESDA, Md. — Researchers have begun the first definitive, large-scale clinical trial to investigate if a vitamin D supplement helps prevent or delay Type 2 diabetes in adults who have prediabetes and are at high risk for developing Type 2. Funded by the National Institutes of Health, the study is taking place at about 20 study sites across the United States, the agency announced Monday.