Content about Maryland

February 22, 2013
FDA approves Genentech breast cancer drug

The Food and Drug Administration has approved a new treatment for late-stage breast cancer, the agency said.

SILVER SPRING, Md. — The Food and Drug Administration has approved a new treatment for late-stage breast cancer, the agency said Friday.

The FDA announced the approval of Genentech's Kadcyla (ado-trastuzumab emtansine) for HER2-positive breast cancer that has spread to other parts of the body. HER2 is a protein involved in the growth of normal cells but found in increased amounts in some kinds of cancer cells, which contributes to cancer cell growth and survival. Genentech is the U.S. subsidiary of Swiss drug maker Roche.

February 20, 2013
Giant Food announces Child Hunger Grants, 2012 contributions

Giant Food, joined by Feeding America food bank leaders, held a press conference to highlight the company's 2012 giving and announce Child Hunger Grants. Giant’s monetary and in-kind contributions exceeded $12 million.

LANDOVER, Md. — Giant Food, joined by Feeding America food bank leaders, held a press conference today to highlight the company's 2012 giving and announce Child Hunger Grants. Giant’s monetary and in-kind contributions exceeded $12 million, which was an increase from $8.3 million in 2011.

February 19, 2013
FDA, FTC crack down on distributors making unapproved cold, flu relief claims

The Food and Drug Administration and the Federal Trade Commission issued a number of warning letters to distributors of "unapproved medicines," noting that because each of the products identified claimed to prevent or treat the cold or flu, they need to be registered and approved by the FDA.

SILVER SPRING, Md. — The Food and Drug Administration and the Federal Trade Commission last week issued a number of warning letters to distributors of "unapproved medicines," noting that because each of the products identified claimed to prevent or treat the cold or flu, they need to be registered and approved by the FDA. And because none of the ingredients listed are in fact monographed OTC cough, cold or flu symptom relievers, those products would additionally need to be filed as "new drugs."

February 15, 2013
FDA seizes tainted product from Florida's Globe All Wellness

U.S. marshals, acting on behalf of the Food and Drug Administration, on Thursday seized tainted products from Globe All Wellness in Hollywood, Fla.

SILVER SPRING, Md. — U.S. marshals, acting on behalf of the Food and Drug Administration, on Thursday seized tainted products from Globe All Wellness in Hollywood, Fla. The products may be unsafe because they contain an undisclosed active pharmaceutical ingredient.

February 14, 2013
Ermis Labs names Hamacher Resource Group marketing and strategic agency of record

Ermis Labs, manufacturer of high-performing skin care items, earlier this month announced Hamacher Resource Group will serve as the company's marketing and strategic agency of record for the retail class of trade.

CROWNSVILLE, Md. — Ermis Labs, manufacturer of high-performing skin care items, earlier this month announced Hamacher Resource Group will serve as the company's marketing and strategic agency of record for the retail class of trade. 

February 14, 2013
United Therapeutics resubmits application for pulmonary arterial hypertension drug

The Food and Drug Administration has accepted the resubmission of a regulatory approval application from United Therapeutics for a drug to treat pulmonary arterial hypertension, the drug maker said.

SILVER SPRING, Md. — The Food and Drug Administration has accepted the resubmission of a regulatory approval application from United Therapeutics for a drug to treat pulmonary arterial hypertension, the drug maker said Thursday.

The FDA originally declined to approve the drug, treprostinil diolamine extended-release tablets, in a letter submitted to the company in October 2012.

The agency plans to decide whether or not to approve the drug in March of this year, United Therapeutics said.

February 11, 2013
Titan Medical Enterprises shut down after violating drug, supplement good manufacturing practices

A federal judge has ordered a California company and its owner to stop manufacturing and distributing drugs and dietary supplements in domestic commerce until their manufacturing operations comply with the Federal Food, Drug, and Cosmetic Act, the Food and Drug Administration reported.

SILVER SPRING, Md. — A federal judge has ordered a California company and its owner to stop manufacturing and distributing drugs and dietary supplements in domestic commerce until their manufacturing operations comply with the Federal Food, Drug, and Cosmetic Act, the Food and Drug Administration reported Friday. 

February 8, 2013
FDA approves generic diabetes drug

The Food and Drug Administration has approved a generic diabetes drug made by Macleods Pharma, according to agency records.

SILVER SPRING, Md. - The Food and Drug Administration has approved a generic diabetes drug made by Macleods Pharma, according to agency records.

The FDA approved Macleods' pioglitazone hydrochloride tablets in the 15 mg, 30 mg and 45 mg strengths.

The drug is a generic version of Takeda's Actos, branded and generic versions of which had sales of about $2.7 billion during the 12-month period that ended in August 2012, according to IMS Health.

February 8, 2013
FDA approves multiple myeloma drug

The Food and Drug Administration has approved a new drug made by Celgene for treating the cancer multiple myeloma, the agency said Friday.

SILVER SPRING, Md. — The Food and Drug Administration has approved a new drug made by Celgene for treating the cancer multiple myeloma, the agency said Friday.

The FDA announced the approval of Pomalyst (pomalidomide) for patients whose disease has progressed after treatment with other cancer drugs.

February 8, 2013
FDA gives tentative approval to Dr. Reddy's hypertension drug

The Food and Drug Administration has given tentative approval to a generic drug for treating hypertension, according to agency records.

 SILVER SPRING, Md. - The Food and Drug Administration has given tentative approval to a generic drug for treating hypertension, according to agency records.

The FDA granted tentative approval to Dr. Reddy's Labs' valsartan tablets in the 40 mg, 80 mg, 160 mg and 320 mg strengths.

The drug is a generic version of Novartis' Diovan. Various versions of the drug had sales of $1.6 billion during the 12-month period that ended in June, according to IMS Health.

February 4, 2013
FDA approves generic cancer drug

The Food and Drug Administration has approved a generic version of a cancer drug in a move that the agency said would help relieve shortages.

SILVER SPRING, Md. — The Food and Drug Administration has approved a generic version of a cancer drug in a move that the agency said would help relieve shortages.

The FDA announced the approval of Sun Pharma Global's doxorubicin hydrochloride liposome injection, a generic version of Johnson & Johnson's Doxil. The drug is currently on the agency's list of drugs experiencing shortages.

February 1, 2013
FDA approves new drug for potentially deadly ammonia conditions

The Food and Drug Administration has approved a new drug for treating some disorders that harm the body's ability to remove ammonia from the blood, the agency said Friday.

SILVER SPRING, Md. — The Food and Drug Administration has approved a new drug for treating some disorders that harm the body's ability to remove ammonia from the blood, the agency said Friday.

January 31, 2013
Wegmans' food drive raises more than $2 million in 2012

During the fall 2012 checkout scanning campaign at 45 Wegmans stores in New Jersey, Virginia, Maryland, eastern Pennsylvania, and the Greater Rochester region of New York, hunger relief donations totaled $1.4 million, Wegmans reported.

ROCHESTER, N.Y. — During the fall 2012 checkout scanning campaign at 45 Wegmans stores in New Jersey, Virginia, Maryland, eastern Pennsylvania, and the Greater Rochester region of New York, hunger relief donations totaled $1.4 million, Wegmans reported Wednesday. 

“We’re thankful for our customers and employees who step up to give in such a generous way,” stated Linda Lovejoy, Wegmans' community relations manager. “Their donations at checkout help reduce hunger that exists right in our own neighborhoods and communities.”

January 30, 2013
FDA approves Genzyme drug for rare cholesterol disorder

The Food and Drug Administration has approved a new drug for treating a rare cholesterol disorder, the agency said.

SILVER SPRING, Md. — The Food and Drug Administration has approved a new drug for treating a rare cholesterol disorder, the agency said.

The FDA announced the approval of Kynamro (mipomersen sodium), made by Genzyme for the treatment of homozygous familial hypercholesterolemia, or HoFH. Kynamro has been approved as an orphan drug, a designation the FDA gives to drugs that treat diseases affecting fewer than 200,000 people.

January 28, 2013
FDA approves three new drugs for Type 2 diabetes

The Food and Drug Administration has approved three new drugs for Type 2 diabetes made by Takeda, the agency said.

SILVER SPRING, Md. — The Food and Drug Administration has approved three new drugs for Type 2 diabetes made by Takeda, the agency said Friday.

The FDA announced the approval of Nesina (alogliptin), Kazano (alogliptin and metformin) and Oseni (alogliptin and pioglitazone) tablets.

Alogliptin is a new active ingredient, while metformin and pioglitazone are drugs already on the market.

January 25, 2013
FDA approves Gleevec for most common pediatric cancer

The Food and Drug Administration has approved a Novartis drug for treating leukemia in children.

SILVER SPRING, Md. — The Food and Drug Administration has approved a Novartis drug for treating leukemia in children.

The FDA said Friday that it approved Gleevec (imatinib) for treating children newly diagnosed with Philadelphia chromosome-positive acute lymphoblastic leukemia, also known as Ph+ ALL.

January 25, 2013
New indication approved for Genentech drug

The Food and Drug Administration has approved a new use for a cancer drug made by Roche unit Genentech, the agency said.

SILVER SPRING, Md. — The Food and Drug Administration has approved a new use for a cancer drug made by Roche unit Genentech, the agency said.

The FDA announced the approval of Avastin (bevacizumab) combined with fluoropyrimidine-irinotecan or fluoropyrimidine-oxaliplatin chemotherapy for treating colorectal cancer that has spread to other parts of the body, also known as metastatic colorectal cancer, or mCRC.

The drug is also approved for treating lung cancer, kidney cancer and brain cancer.

January 23, 2013
FDA approves Novartis drug for rare blood disorder

The Food and Drug Administration has approved a new drug for removing excess iron from the blood in patients with a rare genetic disorder, the agency said.

SILVER SPRING, Md. — The Food and Drug Administration has approved a new drug for removing excess iron from the blood in patients with a rare genetic disorder, the agency said.

The FDA announced the approval of Novartis' Exjade (deferasirox) for patients ages 10 years and older with chronic iron overload resulting from nontransfution-dependent thalassemia, or NTDT. A companion diagnostic, FerriScan, made by Australia-based Resonance Health, also was approved.

January 22, 2013
Va. woman wins Giant-Landover sweepstakes

A customer of Giant Food of Landover, Md., received $7,800 in Giant gift cards after winning an online sweepstakes, the Ahold banner said.

LANDOVER, Md. — A customer of Giant Food of Landover, Md., received $7,800 in Giant gift cards after winning an online sweepstakes, the Ahold banner said Tuesday.

Giant, also known as Giant-Landover to distinguish it from fellow Ahold banner Giant Food Stores of Carlisle, Pa., awarded the cards to customer Sarah Calamore and her family as part of its "Coupon to end All Coupons" sweepstakes, which encouraged customers to "like" the retailer's Facebook page.

January 21, 2013
Giant-Landover donates lunches, water to Inauguration Day law enforcement, participants

A supermarket chain in the Washington area is marking Inauguration Day by donating lunches to the police officers assigned to guard it.

LANDOVER, Md. — A supermarket chain in the Washington area is marking Inauguration Day by donating lunches to the police officers assigned to guard it.

Ahold banner Giant Food of Landover, Md. — also known as Giant-Landover to distinguish it from fellow Ahold banner Giant Food Stores of Carlisle, Pa. — said it would donate boxed lunches and water to the 5,000 officers of the Washington Metropolitan Police Department, U.S. Park Police and National Park Service.

January 21, 2013
Zipnosis now offering online diagnosis, treatment in 11 states

Zipnosis, which provides patient access to mainstream medicine via online diagnosis and the treatment of common health needs, has announced that its services are now available in 11 states across the country.

MINNEAPOLIS and ST. PAUL, Minn. — Zipnosis, which provides patient access to mainstream medicine via online diagnosis and the treatment of common health needs, has announced that its services are now available in 11 states across the country.

Patients who live in Alaska, Colorado, Connecticut, Kentucky, Maryland, Massachusetts, Minnesota, New York, Rhode Island, Washington and Wisconsin can now visit Zipnosis.com and receive a diagnosis and treatment from 8 a.m. to 8 p.m.

January 17, 2013
FDA approves Flublok, a trivalent influenza vaccine not made with eggs

The Food and Drug Administration on Wednesday approved Protein Sciences' Flublok, the first trivalent influenza vaccine made using an insect virus (baculovirus) expression system and recombinant DNA technology.

SILVER SPRING, Md. — The Food and Drug Administration on Wednesday approved Protein Sciences' Flublok, the first trivalent influenza vaccine made using an insect virus (baculovirus) expression system and recombinant DNA technology. 

January 17, 2013
FDA approves sterile blood-plasma product

The Food and Drug Administraiton has approved a drug for replacing clotting proteins in the blood for conditions in which patients have too little of them.

SILVER SPRING, Md. — The Food and Drug Administraiton has approved a treatment for replacing clotting proteins in the blood for conditions in which patients have too little of them.

The FDA announced the approval of Octapharma's Octaplas, a sterile, frozen solution of pooled human plasma from multiple donors that has been treated with a solvent detergent process.

January 17, 2013
Gourmet-within-a-store: Giant-Carlisle to debut in-store Di Bruno Bros. cheese shop

Ahold banner Giant Food Stores is opening a cheese and specialty food store in central Pennsylvania, the supermarket chain said.

CARLISLE, Pa. — Ahold banner Giant Food Stores is opening a cheese and specialty food store in central Pennsylvania, the supermarket chain said.

Giant — also known as Giant-Carlisle to distinguish it from fellow Ahold chain Giant Foods of Landover, Md. — said it had a deal with Philadelphia-based Di Bruno Bros. to open the store inside the Giant Super Food Store in Camp Hill, Pa. The new store-within-a-store will open on Jan. 24.

January 16, 2013
FDA sets generic drug user fee rates for 2013

The Food and Drug Administration has set user fee rates for generic drug companies, the agency said.

SILVER SPRING, Md. — The Food and Drug Administration has set user fee rates for generic drug companies, the agency said Wednesday.

The FDA announced that it had published a notice in the Federal Register for companies that make finished dosage forms, meaning drugs in their final form, and active pharmaceutical ingredients, meaning the main ingredients of the drugs.