Regulatory and Washington

01/04/2012 - 11:30am
Election analyst, professor Larry Sabato to address 2012 NACDS Annual Meeting

The National Association of Chain Drug Stores has announced that election analyst and University of Virginia professor Larry Sabato will address attendees at the 2012 NACDS Annual Meeting on April 21 to 24 in Palm Beach, Fla.

01/04/2012 - 11:26am
FDA approves Actavis ADHD drug

The Food and Drug Administration has approved a generic version of a drug for attention deficit hyperactivity disorder made by Actavis, the drug maker said Wednesday.

01/03/2012 - 3:01pm
FDA approves new REMS for fentanyl-based painkillers

The Food and Drug Administration is streamlining the enrollment process for risk evaluation and mitigation strategies for a class of painkillers, the agency said Tuesday.

01/03/2012 - 2:47pm
FDA panel to review potential new use for Xgeva

Drug maker Amgen will discuss the supplemental biologics license application of Xgeva before a Food and Drug Administration review panel next month.

01/03/2012 - 2:11pm
FDA, CDC affirm safety of Mead Johnson's Enfamil; tests for Cronobacter negative

Mead Johnson's infant formulas, including Enfamil Premium Newborn, are safe, according to results of testing by both the Food and Drug Administration and the Centers for Disease Control and Prevention.

01/03/2012 - 1:09pm
FDA panel to review resubmitted NDA for pixantrone

The Food and Drug Administration's Oncologic Drugs Advisory Committee will review a resubmitted new drug application for a cancer treatment made by Cell Therapeutics.

01/03/2012 - 12:53pm
FDA approves Prevnar 13 in older adults

The Food and Drug Administration has approved a Pfizer vaccine for Streptococcus pneumoniae in adults ages 50 years and older, the company said.

01/03/2012 - 12:39pm
FDA approves Mylan epilepsy drug

The Food and Drug Administration has approved a drug for epilepsy made by Mylan, the drug maker said.

01/03/2012 - 10:54am
FDA accepts application for Gilead HIV drug

The Food and Drug Administration has accepted a regulatory approval application from Gilead Sciences for a drug to treat HIV, the company said.

01/03/2012 - 10:46am
Mead Johnson retests Enfamil batch and affirms no contamination

Mead Johnson Nutrition over the holidays conducted a new round of testing on samples of a batch of Enfamil Premium Newborn powdered formula related to a Food and Drug Administration investigation.

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