Content about Maryland

November 27, 2012

Indian generic drug maker Wockhardt received three new drug approvals from the Food and Drug Administration, agency records show.

SILVER SPRING, Md. — Indian generic drug maker Wockhardt received three new drug approvals from the Food and Drug Administration, agency records show.

November 21, 2012

FDA approves first flu vaccine manufactured by Novartis using cell culture technology

The Food and Drug Administration on Wednesday announced the approval of Novartis' Flucelvax, the first seasonal influenza vaccine licensed in the United States produced using cultured animal cells, instead of fertilized chicken eggs.

SILVER SPRING, Md. — The Food and Drug Administration on Wednesday announced the approval of Novartis' Flucelvax, the first seasonal influenza vaccine licensed in the United States produced using cultured animal cells, instead of fertilized chicken eggs. Flucelvax is approved to prevent seasonal influenza in people ages 18 years and older.

November 21, 2012

Minnesota company barred from going to market for violations of drug and dietary supplement regs

Pharmacist’s Ultimate Health of St. Paul, Minn., and its president, Stephen J. Poindexter, have been barred from distributing any "unapproved new drugs" that the company had distributed under the guise that they were dietary supplements.

SILVER SPRING, Md. — Pharmacist’s Ultimate Health of St. Paul, Minn., and its president, Stephen J. Poindexter, have been barred from distributing any "unapproved new drugs" that the company had distributed under the guise that they were dietary supplements.

The consent decree of permanent injunction that had been sought by the Food and Drug Administration was signed by U.S. District Judge David Doty of the U.S. District Court for the District of Minnesota on Nov. 6.

November 20, 2012

Giant-Landover donates 1,000 turkeys to local food bank

Giant-Landover donated 1,000 turkeys to a nearby food bank last week to help families in need enjoy Thanksgiving, the Ahold-owned chain said.

LANDOVER, Md. — Giant-Landover donated 1,000 turkeys to a nearby food bank last week to help families in need enjoy Thanksgiving, the Ahold-owned chain said.

The chain, officially known as Giant Food and based in Landover, Md., sent President Anthony Hucker and VP Finance Brian Shelton to the Capital Area Food Bank to present 1,000 turkeys on Friday. Shelton is also a board member of the food bank.

November 19, 2012

Pfizer, Cystic Fibrosis Foundation Therapeutics partner in drug-discovery initiative

The drug-discovery division of the Cystic Fibrosis Foundation is teaming up with drug maker Pfizer to find new treatments for patients with the most common genetic mutation of the disease.

BETHESDA, Md. — The drug-discovery division of the Cystic Fibrosis Foundation is teaming up with drug maker Pfizer to find new treatments for patients with the most common genetic mutation of the disease.

November 19, 2012

Report: Teen smoking falls significantly across 41 states

Current cigarette smoking among 12- to 17-year-olds fell significantly from 2002 to 2010 in 41 states, according to a report by the Substance Abuse and Mental Health Services Administration issued last week.

ROCKVILLE, Md. — Current cigarette smoking among 12- to 17-year-olds fell significantly from 2002 to 2010 in 41 states, according to a report by the Substance Abuse and Mental Health Services Administration issued last week. The report also found that during the same period, adolescent perception of risk from cigarette smoking has remained unchanged in most states.

November 19, 2012

Study: Asthmatics have a tougher time trying to quit smoking

A new University of Cincinnati study released last week examined how anxiety sensitivity can thwart the efforts of smokers with asthma to quit smoking.

CINCINNATI — A new University of Cincinnati study released last week examined how anxiety sensitivity can thwart the efforts of smokers with asthma to quit smoking. This new direction of research from Alison McLeish, a UC assistant professor of psychology, was presented Nov.17 at the 46th annual convention of the Association of Behavioral and Cognitive Therapies in National Harbor, Md.

November 15, 2012

FDA panel advises against Merck's Oxytrol patch Rx-to-OTC switch application

The Food and Drug Administration's Nonprescription Drugs Advisory Committee on Friday voted against Merck's application to switch its Oxytrol patch from prescription-only to over the counter, citing concerns over use of therapy for an overactive bladder in women without a doctor's intervention.

SILVER SPRING, Md. — The Food and Drug Administration's Nonprescription Drugs Advisory Committee on Friday voted against Merck's application to switch its Oxytrol patch from prescription-only to over the counter, citing concerns over use of therapy for an overactive bladder in women without a doctor's intervention.

The committee voted five in favor and six opposed, also citing concerns that men might inappropriately choose to use the product as well.

November 7, 2012

FDA issues warning letter to company making illegal claims in support of light therapy device

The Food and Drug Administration on Monday issued a warning letter to The Avalon Effect, a company based in Franklin, Tenn., for its marketing of a light therapy product that claims to cure or treat symptoms of fungal meningitis, methicillin-resistant Staphylococcus aureus, concussions, Lyme disease and other diseases.

SILVER SPRING, Md. — The Food and Drug Administration on Monday issued a warning letter to The Avalon Effect, a company based in Franklin, Tenn., for its marketing of a light therapy product that claims to cure or treat symptoms of fungal meningitis, methicillin-resistant Staphylococcus aureus, concussions, Lyme disease and other diseases.

November 6, 2012

FDA approves Pfizer rheumatoid arthritis drug

The Food and Drug Administration has approved a drug for rheumatoid arthritis ahead of the day the agency was scheduled to decide whether or not to approve it, the agency said Tuesday.

SILVER SPRING, Md. — The Food and Drug Administration has approved a drug for rheumatoid arthritis ahead of the day the agency was scheduled to decide whether or not to approve it, the agency said Tuesday.

November 6, 2012

Nutramax fends off faulty class action suit

Nutramax Laboratories recently announced the defeat of a class action lawsuit brought against the company in a California court. In April, Nutramax was named in a class action regarding its CosaminDS Joint Health Supplement. Plaintiffs claimed the glucosamine/chondroitin supplement did not work in relieving joint pain as advertised.

EDGEWOOD, Md. — Nutramax Laboratories recently announced the defeat of a class action lawsuit brought against the company in a California court. In April, Nutramax was named in a class action regarding its CosaminDS Joint Health Supplement. Plaintiffs claimed the glucosamine/chondroitin supplement did not work in relieving joint pain as advertised.

November 2, 2012

Retailers, suppliers recover, provide relief in Sandy's aftermath

The Northeast is still recovering from one of the worst disasters it has ever faced. Many residents remain without electrical power, while others have lost their entire homes, businesses, workplaces and in a growing number of cases, their lives.

NEW YORK — The Northeast is still recovering from one of the worst disasters it has ever faced. Many residents remain without electrical power, while others have lost their entire homes, businesses, workplaces and in a growing number of cases, their lives.

November 1, 2012

Wegmans able to get all stores open in wake of Hurricane Sandy

Wegmans Food Markets on Tuesday reported that they were able to open all 81 of the company’s stores in the six states where they do business, all of which were affected to some degree by Hurricane Sandy.

ROCHESTER, N.Y. — Wegmans Food Markets on Tuesday reported that they were able to open all 81 of the company’s stores in the six states where they do business, all of which were affected to some degree by Hurricane Sandy. Wegmans’ stores are located in New York, New Jersey, Pennsylvania, Virginia, Maryland and Massachusetts.

October 26, 2012

FDA approves Teva's Synribo for blood and bone marrow cancer

The Food and Drug Administration has approved what it called the second new drug in two months for a form of leukemia, the agency said Friday.

SILVER SPRING, Md. — The Food and Drug Administration has approved what it called the second new drug in two months for a form of leukemia, the agency said Friday.

The FDA announced the approval of Teva Pharmaceutical Industries' Synribo (omacetaxine mepesuccinate) for chronic myelogenous leukemia, or CML, a disease that the National Institutes of Health expects will be diagnosed in more than 5,400 people this year. The drug is intended for patients whose disease has progressed after treatment with at least two drugs of a class used to treat the disease.

October 26, 2012

FDA cracks down on violators of dietary supplement regulations

The Food and Drug Administration on Thursday announced a pair of penal actions against companies operating outside of dietary supplement regulations.

SILVER SPRING, Md. — The Food and Drug Administration on Thursday announced a pair of penal actions against companies operating outside of dietary supplement regulations.

A federal judge granted the FDA a permanent injunction against Truman Berst, doing business as Alternative Health & Herbs Remedies of Albany, Ore., for selling products represented as herbs and supplements with claims for treating diseases.

October 26, 2012

FDA: Contamination found at Mass. compounding pharmacy linked to meningitis deaths

The Food and Drug Administration said it found a number of problems with cleanliness at a compounding pharmacy linked to a meningitis outbreak that has so far sickened hundreds of people and killed two dozen in a report released Friday.

SILVER SPRING, Md. — The Food and Drug Administration said it found a number of problems with cleanliness at a compounding pharmacy linked to a meningitis outbreak that has so far sickened hundreds of people and killed two dozen in a report released Friday.

October 25, 2012

FDA declines approval of United Therapeutics PAH drug

The Food and Drug Administration has declined to approve a drug developed by United Therapeutics Corp. for treating a potentially lethal high blood pressure condition.

SILVER SPRING, Md. — The Food and Drug Administration has declined to approve a drug developed by United Therapeutics Corp. for treating a potentially lethal high blood pressure condition.

The drug maker said it received a complete response letter from the agency for its application for a tablet formulation of the drug treprostinil. The company already markets the drug in injectable and inhaled formulations for pulmonary arterial hypertension, or PAH, a condition that causes high blood pressure in the arteries of the lungs.

October 22, 2012

FDA approves Eisai's Fycompa for epilepsy

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

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

The FDA announced the approval of Eisai's Fycompa (perampanel) tablets to treat partial-onset seizures in patients ages 12 years and older. Partial seizures are the most common type seen in people with epilepsy, according to the FDA.

October 19, 2012

FDA gives tentative approval to Cipla combo pill for HIV

The Food and Drug Administration has given tentative approval to a new drug for HIV made by an Indian company.

SILVER SPRING, Md. — The Food and Drug Administration has given tentative approval to a new drug for HIV made by an Indian company.

FDA records show that the agency gave tentative approval tablets and oral suspension that combine lamivudine, nevirapine and zidovudine in the 30-mg/50-mg/60-mg strength.

October 18, 2012

FDA approves first drug for eye condition

The Food and Drug Administration has approved what it called the first drug to treat an eye condition that can interfere with the part of the retina responsible for reading vision.

SILVER SPRING, Md. — The Food and Drug Administration has approved what it called the first drug to treat an eye condition that can interfere with the part of the retina responsible for reading vision.

The agency announced the approval of Jetrea (ocriplasmin), made by Iselin, N.J.-based ThromboGenics. The drug is used to treat symptomatic vitreomacular adhesion.

October 16, 2012

Walgreens introduces WellTransitions, a coordinated care model that works in tandem with hospitals

Walgreens pharmacists are on the frontlines of a new transition of care program, WellTransitions, which brings hospitals and health systems together with Walgreens in a coordinated care model designed to reduce readmission rates and overall healthcare costs while improving patient health outcomes and medication adherence, Walgreens announced.

DEERFIELD, Ill. — Walgreens pharmacists are on the frontlines of a new transition of care program, WellTransitions, which brings hospitals and health systems together with Walgreens in a coordinated care model designed to reduce readmission rates and overall healthcare costs while improving patient health outcomes and medication adherence, Walgreens announced Tuesday. The WellTransitions program is being rolled out as thousands of hospitals nationwide face possible penalties from Medicare for patient readmission rates that are too high, under a new law that took effect Oct.

October 12, 2012

FDA petitions appellate court to revisit tobacco decision restricting government graphic-image mandate

The Food and Drug Administration took the Family Smoking Prevention and Tobacco Control Act of 2009 one step closer to being considered by the Supreme Court earlier this week.

SILVER SPRING, Md. — The Food and Drug Administration took the Family Smoking Prevention and Tobacco Control Act of 2009 one step closer to being considered by the Supreme Court earlier this week. The FDA recently petitioned the D.C. Circuit Court of Appeals to revisit the court's August decision that ruled in favor of the tobacco industry and precluded the FDA from mandating that graphic images depicting the consequences of smoking be placed on all cigarette packaging.

October 11, 2012

Medicine-On-Time launches site to promote medication adherence system

A company that manufactures simplified packaging designed to increase medication adherence has launched a new website to promote the product.

HUNT VALLEY, Md. — A company that manufactures simplified packaging designed to increase medication adherence has launched a new website to promote the product.

Medicine-On-Time announced the launch of a new website that connects patients to pharmacies that offer the packaging. The launch includes 250 pharmacies around the country, a number that the company expects to grow. The packaging system is geared toward patients taking multiple drugs and uses personalized pill cups labeled with the day, date and time to take them.

October 8, 2012

U.S. frozen foods market experiencing flat to declining sales

The U.S. frozen foods market has hit a rough patch, according to a new study from Packaged Facts.

ROCKVILLE, Md. — The U.S. frozen foods market has hit a rough patch, according to a new study from Packaged Facts.

October 5, 2012

FDA, Interpol collaborate on crackdown of illegal Web pharmacies

In partnership with international regulatory and law enforcement agencies, the Food and Drug Administration on Thursday announced it had taken action against more than 4,100 Internet pharmacies that illegally sell unapproved drugs to consumers.

SILVER SPRING, Md. — In partnership with international regulatory and law enforcement agencies, the Food and Drug Administration on Thursday announced it had taken action against more than 4,100 Internet pharmacies that illegally sell unapproved drugs to consumers. Actions taken include civil and criminal charges, seizure of illegal products and removal of offending websites.