Content about Pharmaceutical sciences

November 25, 2013

Federal regulators are lifting some restrictions on a diabetes drug that were placed two years ago after studies linked the drug to increased cardiovascular risk.

November 22, 2013

Sandoz has launched an authorized generic version of a topical drug for treating actinic keratosis, the company said.

November 22, 2013

Teva Pharmaceutical Industries has launched its generic version of a drug for patients with cystic fibrosis, the Israeli drug maker said Thursday.

November 22, 2013

On Nov. 18, the Senate passed by voice vote the Drug Quality and Security Act, sending to president Barack Obama's desk legislation that implements federal tracking and tracing of drugs and strengthens federal regulations on pharmacy compounding.

The bipartisan bill, which has the support of such trade groups as the National Association of Chain Drug Stores, the National Community Pharmacists Association and the Generic Pharmaceutical Association, ties up a couple of problematic loose ends in the pharmaceutical supply chain, namely the so-called "downstream" supply chain, which refers to the path that drugs take from their manufacturers to providers and patients, as well as sterile compounding.

November 21, 2013

The Food and Drug Administration has declined to approve an experimental drug for schizophrenia and bipolar disorder developed by Forest Labs and Gedeon Richter, a Hungarian drug company, the two said Thursday.

November 21, 2013

The National Association of Chain Drug Stores has announced that in lead-up to a hearing of the Subcommittee on Health of the U.S. House of Representatives Committee on Energy and Commerce, it has submitted a statement emphasizing the important collaborative role that pharmacy plays in helping to ensure that prescription medications are used appropriately and that local communities are safe.

November 21, 2013

Health care has begun to emphasize quality in addition to cost as a means to provide what is known as value-driven health care.

November 21, 2013

Expanding the role of pharmacists can help reduce the burden of chronic illness on patients and potentially save Canada’s system an estimated $1.4 billion to $1.9 billion dollars over three years. That’s according to the recent Pharmaprix/Shoppers Drug Mart "Sustainable Solutions Report: A Focus on Managing Complex Chronic Diseases."

November 21, 2013

Pharmacists traditionally have been one of the most underutilized members of the healthcare team, possibly because they hadn’t been officially recognized as part of that team. That, however, is about to change.

November 20, 2013

Navarro Discount Pharmacy has been selected by OutcomesMTM as 1-of-4 pharmacies in the Southeast region recognized for its commitment to patient therapy management and the health of its patients.

November 20, 2013

Drug maker Perrigo has filed with the Food and Drug Administration for approval of a generic topical ointment for treating acne in adolescents and adults, the company said Wednesday.

November 20, 2013

More than six dozen pharmacists and pharmacy students from in and around the District of Columbia offered free health screenings on Capitol Hill Tuesday as a way to promote awareness of the role pharmacists play in the healthcare system.

November 20, 2013

Following actions by the Food and Drug Administration, USPLabs has agreed to recall and destroy the dietary supplement OxyElite Pro, as it has been linked to dozens of cases of acute liver failure and hepatitis, including one death and illnesses so severe that several patients required liver transplants, the agency noted Wednesday.

November 19, 2013

SILVER SPRING, Md. — At the request of the Food and Drug Administration, U.S. Marshals seized dietary supplements manufactured and held by Hi-Tech Pharmaceuticals, located in Norcross, Ga., after FDA investigators found the products contained 1, 3-Dimethylamylamine HCl (DMAA) or its chemical equivalent, the agency announced Monday.

“This company has a responsibility to ensure its products are safe for distribution and human consumption,” stated Melinda Plaisier, the FDA’s associate commissioner for regulatory affairs. “We have taken action to protect consumers and demonstrate our commitment to their safety by keeping these products from entering the distribution system.”

The retail value of the seized products is more than $2 million, the agency estimated.

A complaint filed in the U.S. District Court for the Northern District of Georgia alleged that the products were adulterated according to the Federal Food, Drug, and Cosmetic Act because they contain DMAA, an unapproved food additive that is deemed unsafe under the law.

The FDA is urging consumers not to buy or use supplements containing DMAA, which can elevate blood pressure and could lead to cardiovascular problems, including heart attack, shortness of breath and tightening of the chest. Given the known biological activity of DMAA, the ingredient may be particularly dangerous when used with caffeine. Consumers should check labels and avoid any dietary supplements containing DMAA, which is referred to on different product labels by 10 possible names. The FDA has warned consumers about the health risks of DMAA on its web site.

On Nov. 12, 2013, U.S. Marshals seized more than 1,500 cases of finished goods and more than 1,200 pounds of in-process/raw material goods from the Hi-Tech Pharmaceuticals facility.

During the FDA’s inspection of Hi-Tech Pharmaceuticals, which began in October, investigators identified 11 products that were labeled as containing DMAA or its chemical equivalent. These products included Black Widow, ECA Xtreme, Fastin, Fastin-XR, Lipodrene, Lipodrene Hardcore, Lipodrene XR, Lipodrene Xtreme, Lipotherm, Stimerex-ES, and Yellow Scorpion. The investigators also observed bulk DMAA raw ingredients at the facility. Prior to the seizure, on Nov. 1, 2013, the FDA issued an administrative detention, temporarily holding the products until they were seized.

Dietary supplements containing DMAA are illegal and the FDA is using all available tools at its disposal to remove these products from the market. In 2012, the FDA issued warning letters to companies notifying them that products containing DMAA need to be taken off the market or reformulated to remove this substance.

November 19, 2013

A pair of Congress leaders — Reps. Doug Collins, R-Ga., and Martha Roby, R-Ala. — on Tuesday advocated for community pharmacy with letters addressed to the leaders of the House Energy and Commerce Committee and Ways and Means Committee.

November 18, 2013

Drug maker Actavis hopes to become the first to market with a generic version of a topical testosterone replacement drug marketed by Eli Lilly, Actavis said.

November 18, 2013

Chain Store Guide on Friday released its latest analysis on the recently-completed Kerr Drug acquisition by Walgreens.

November 18, 2013

A bill that would implement federal tracking and tracing of drugs and strengthen federal regulations on pharmacy compounding has passed in the Senate and will go to President Barack Obama for his signature.

November 15, 2013

A Food and Drug Administration expert panel has voted to recommend approval for a drug to treat a circadian rhythm disorder that affects most people with total blindness.

November 15, 2013

The Food and Drug Administration has approved a new drug for fungal infections of the skin made by Valeant Pharmaceuticals International, the drug maker said Friday.

November 15, 2013

The Food and Drug Administration has approved an OTC personal lubricant that helps couples conceive more easily.

November 15, 2013

The Food and Drug Administration has given orphan drug designation to an experimental treatment for a rare form of epilepsy.

November 15, 2013

The value of drugs approved in the United States this year could reach almost $19 billion in sales five years after their launch, exceeding the value of drugs approved in 2012, according to a new report.

November 14, 2013

The Food and Drug Administration has requested label and packaging changes of certain over-the-counter topical antiseptic products, according to an FDA MedWatch alert.

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