Content about Regulatory and Washington

January 4, 2012

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.

January 3, 2012

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

January 3, 2012

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

January 3, 2012

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.

January 3, 2012

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

January 3, 2012

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

January 3, 2012

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.

January 3, 2012

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.

January 3, 2012

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.

December 23, 2011

Rather than take off for Christmas, the editors of Drug Store News took a look at the year ahead and the stories, issues and trends that will make headlines in retail pharmacy in 2012.

December 23, 2011

The Food and Drug Administration's Endocrinologic and Metabolic Drugs Advisory Committee is set to review an investigational treatment for obesity.

December 23, 2011

The Food and Drug Administration on Thursday urged consumers to carefully read the labels of liquid acetaminophen marketed for infants to avoid giving the wrong dose to their infants.

December 23, 2011

So far two retailers — Supervalu and Walmart — have pulled lots of Emfamil Premium Newborn powdered formula before any recall has been issued after learning of an infant's death this past weekend, according to published reports.

December 22, 2011

Larry Hausner, the CEO of the American Diabetes Association, will serve as the 2012 chairman of the National Health Council's board of directors, NHC said.

December 22, 2011

Amneal Pharmaceuticals has launched its generic version of a drug designed to treat seizures in adults and children with epilepsy.

December 22, 2011

McNeil Consumer Healthcare on Wednesday issued a voluntarily recall of certain lots of Motrin IB coated tablets from retailers.

December 21, 2011

The Food and Drug Administration has approved a new drug for high blood pressure made by Takeda, the drug maker said.

December 21, 2011

The branded subsidiary of Impax Labs has submitted a new drug application for its investigational idiopathic Parkinson's disease treatment to the Food and Drug Administration.

December 21, 2011

According to the National Community Pharmacists Association, changes governing long-term care facilities that recently were proposed by the Centers for Medicare and Medicaid Services could create turmoil for independent community pharmacies providing LTC services, the association stated in a release Wednesday.

December 21, 2011

The Food and Drug Administration has approved an HIV drug for children and adolescents, the agency said Wednesday.

December 21, 2011

Ranbaxy Labs said Wednesday that it had resolved long-standing issues concerning two of its manufacturing plants in India with the U.S. government.

December 21, 2011

Drug maker Santarus has submitted a new drug application with the Food and Drug Administration for a treatment for ulcerative colitis, the company said.

December 20, 2011

Pfizer is seeking approval from the Food and Drug Administration for its investigational treatment of moderately to severely active rheumatoid arthritis.

December 20, 2011

The Pharmacy Technician Certification Board on Tuesday announced a push to inform patients with practical solutions on how to best utilize remaining 2011 flexible spending account funds.

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