October 30, 2014

AstraZeneca on Thursday announced that the Food and Drug Administration approved Xigduo XR (dapagliflozin and metformin hydrochloride extended-release), a once-daily drug for the treatment of adults with Type 2 diabetes. 

October 27, 2014

The National Association of Drug Diversion Investigators on Friday highlighted the latest results achieved by Alabama's real-time, stop-sale pseudoephedrine tracking system.

October 24, 2014

Pfizer on Thursday announced that the U.S. District Court for the District of Delaware upheld its basic patent and the L-malate salt patent covering Sutent (sunitinib malate) capsules.

October 22, 2014

Pfizer last week announced that the Food and Drug Administration approved a revised label for Embeda (morphine sulfate and naltrexone hydrochloride) extended-release capsules, for oral use, CII, to include abuse-deterrence studies. 

 

October 22, 2014

The Food and Drug Administration last week announced plans to survey pharmacists and patients about their experiences resulting from changes in generic drug pill appearance.

October 22, 2014

A JAMA study noted that about two-thirds of dietary supplements recalled by the Food and Drug Administration still contained banned ingredients at least six months after being recalled.

October 17, 2014

The Congressional Dietary Supplement Caucus hosted an educational briefing and luncheon for congressional staffers on Oct. 14, the day before the 20th anniversary of the passage of the Dietary Supplement Health and Education Act.

October 17, 2014

With open enrollment for the 2015 health insurance plan year set to begin on Nov. 15, National Association of Chain Drug Stores members were invited by Secretary of Health and Human Services Sylvia Burwell to participate in a pharmacy issues meeting on Friday.

October 16, 2014

The Food and Drug Administration has granted approval to Esbriet (pirfenidone), as well as Ofev (nintedanib), to treat idiopathic pulmonary fibrosis — a condition in which the lungs scar over time.

October 15, 2014

Could the regulatory and scientific logjam that’s keeping copycat biotech medicines off the market and out of the hands of patients and health providers in the United States finally be breaking?

October 15, 2014

The U.S. Supreme Court on Wednesday heard arguments from Teva Pharmaceutical Industries in defense of the patent protecting its $4 billion multiple sclerosis drug Copaxone, according to a Reuters report. 

October 15, 2014

As the Food and Drug Administration begins to explore ways to improve its user-fee program for generic drugs, the Generic Pharmaceutical Association and its members have weighed in with suggestions on how to shore up the law to ensure that it helps bring generics to market faster and provides benefits across the entire healthcare system.

October 15, 2014

What’s in a name? A lot, apparently, if the name applies to a biosimilar medicine.

October 14, 2014

U.S. Sen. Bernie Sanders, I-Vt., and U.S. Rep. Elijah Cummings, D-Md., earlier this month launched an investigation into soaring generic drug prices.

October 14, 2014

Adults in the United States suffered from approximately 14 million major medical conditions attributable to smoking, according to a study published in the journal JAMA Internal Medicine Monday.

October 14, 2014

Twenty African-American and Hispanic community and health care organizations earlier this month submitted a letter to the Food and Drug Administration raising concerns that its Proposed Rule on Generic Labeling could jeopardize patient safety and access to affordable medicines. 

October 10, 2014

The Consumer Electronics Association on Thursday released a new study of adult Americans with hearing loss, finding that only 1-in-25 of those surveyed now own personal sound amplification products, and nearly 40% are interested in over-the-counter products to help them hear better.

October 10, 2014

The Food and Drug Administration on Friday approved Akynzeo (netupitant and palonosetron) for the treatment of nausea and vomiting in patients who are undergoing cancer chemotherapy.

October 10, 2014

The Food and Drug Administration on Friday approved Gilead's Harvoni (ledipasvir and sofosbuvir) to treat chronic hepatitis C virus genotype 1 infection.

October 9, 2014

Congress and the sports nutrition industry independently called upon the Food and Drug Administration to act on removing an untested synthetic stimulant that was found in 12 products marketed as sports nutrition supplements.

October 9, 2014

The Food and Drug Administration earlier this month issued draft guidance with several recommendations for manufacturers of acetaminophen products. 

October 9, 2014

The recently amended NABP Model State Pharmacy Act and Model Rules of the National Association of Boards of Pharmacy are now available to assist the state boards of pharmacy in developing state laws or board rules in their efforts to protect the public health, NABP posted on its website Wednesday. 

October 9, 2014

Salix Pharmaceuticals on Thursday announced that the Food and Drug Administration granted final approval for the company's Uceris (budesonide) rectal foam for patients with mild-to-moderate distal ulcerative colitis. 

October 8, 2014

"What happens when student pharmacists discover that their professional path may prove equal parts public health and public policy?"