May 13, 2013

The Food and Drug Administration's temporary stay pending its appeal of a district court decision ordering all levonorgestrel-based emergency contraceptives be available without a prescription and without any age restrictions was extended through May 28 by the U.S. Court of Appeals for the Second Circuit.

May 10, 2013

The Food and Drug Administration has approved a biotech drug made by Novartis for treating a form of arthritis that affects children, the Swiss drug maker said Friday.

May 10, 2013

Senior U.S. District Judge Edward Korman on Friday denied a Food and Drug Administration motion for a stay pending an appeal of Korman's earlier decision that all levonorgestrel-based emergency contraceptives be available without a prescription and without any age restrictions.

May 10, 2013

The Specialty Pharmacy Certification Board will begin certifying specialty pharmacists who pass a comprehensive exam in October. The exam is designed to cover the entire specialty pharmacy process, including intake, clinical management, fulfillment and outcomes.

The National Association of Specialty Pharmacy, which oversees the SPCB, is bringing to bear some real advocacy and structure to the highly fragmented specialty pharmacy marketplace. The DSN Group, including its specialty pharmacy publication of the same name Specialty Pharmacy, applauds these efforts.

May 9, 2013

The Drug Enforcement Administration collected more than 371 tons of unused medications last month as part of its sixth annual drug take-back program, the agency said.

May 9, 2013

Declining use overall of healthcare services drove down spending on medicines in the United States by 3.5% per capita last year, according to a new study.

May 9, 2013

Bipartisan legislation that would let pharmacists devote more time to Medicare beneficiaries and less to adjudicating claims with pharmacy benefit management firms was introduced in the U.S. Senate and won the backing of the National Community Pharmacists Association earlier this week.

May 9, 2013

The November 2011 expiration of Pfizer's patent on the cholesterol drug Lipitor and Ranbaxy Labs' release of the generic version received significant play in the media, particularly due to the theretofore status of Lipitor (atorvastatin calcium) as the drug with the highest sales in the country, $7.7 billion in the United States, according to healthcare analytics firm IMS Health.

May 9, 2013

Wrigley announced the company is temporarily stopping the sale and marketing of its new Alert Energy caffeinated gum "out of respect" for the Food and Drug Administration as they agency investigates the safety of added caffeine in foods.

May 9, 2013

One of the difficulties that federal regulators ran into during the nationwide scandal surrounding the New England Compounding Center — the Massachusetts-based pharmacy blamed for a nationwide fungal meningitis epidemic that has sickened hundreds and killed dozens — was the issue of when such pharmacies cross the line from compounding to manufacturing.

May 8, 2013

Drug maker Bristol-Myers Squibb foresees significant effects on its business from the Patient Protection and Affordable Care Act, company executives told attendees of its recent shareholder meeting.

May 8, 2013

Drug maker Merck is seeking regulatory approval for an experimental tablet placed under the tongue that could be used to treat ragweed allergies.

May 8, 2013

There is as much as $10 billion in branded pharmaceutical sales that could make the switch from prescription-only to over-the counter in the next five years, suggested Joseph Papa, Perrigo chairman, CEO and president, to analysts on Tuesday.

May 7, 2013

A Walgreens survey found that 37% of Medicare Part D beneficiaries have daily concerns about their prescription drug costs, and 1-in-5 say they’ve had to make sacrifices, such as delaying filling a prescription or skipping doses, to help manage medication costs.

May 7, 2013

The global market for biosimilars will be worth nearly $2.5 billion this year, according to a new study.

May 6, 2013

Pfizer is attempting to stem the rise of counterfeit medicines by selling one of its most popular drugs — and one of the most popular targets for counterfeiters — online.

May 6, 2013

The Food and Drug Administration has approved a drug for HIV in infants and toddlers.

May 6, 2013

The Food and Drug Administration has approved a new drug made by Merck for treating high cholesterol, the drug maker said.

May 6, 2013

An experimental drug regimen under development by AbbVie could change the way hepatitis C is treated, according to a special designation it received from the Food and Drug Administration.

May 6, 2013

The Food and Drug Administration may soon find itself in another Plan-B-generated quandary — the complications around granting a three-year marketing exclusivity for a medicine that is both prescription-only and over-the-counter, according to an FDA Law Blog posted Sunday by Hyman, Phelps & McNamara.

May 6, 2013

Florida's state legislature approved a bill last week that will allow pharmacists to substitute biosimilars for brand name biotech drugs.

May 6, 2013

The five associations representing the dietary supplement industry on Monday requested that the Food and Drug Administration issue revised guidance on new dietary ingredient notifications, with a specific focus on the information to be included to identify the new dietary ingredient.

May 6, 2013

Retail pharmacies, drug makers and law enforcement have a variety of methods used to fight organized crime, and the New Jersey Office of the Attorney General has drawn up a list of best practices that pharmacies can use to keep stores, drugs, staff and customers safe.

May 6, 2013

Pregnant women should not use migraine-prevention medications containing valproate sodium due to a higher risk of decreased IQ scores in children, the Food and Drug Administration warned.