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