Content about Regulatory and Washington

May 24, 2011
Taro gets nod to market generic Zyrtec for kids

The Food and Drug Administration has approved a generic over-the-counter treatment for allergies made by Taro Pharmaceutical Industries.

May 23, 2011
Amneal to manufacture generic Furadantin

A generic drug maker has been granted approval from the Food and Drug Administration to manufacture its version of a urinary tract infection treatment.

May 23, 2011
FDA approves Incivek as hepatitis C treatment

The Food and Drug Administration has approved a treatment for hepatitis C made by Vertex Pharmaceuticals, the agency said Monday.

May 23, 2011
Mylan receives FDA approval for generic Depakote Sprinkle capsules

The Food and Drug Administration has approved a generic drug for epilepsy made by Mylan.

May 23, 2011
Sutent OKed as pancreatic NET treatment

The Food and Drug Administration has approved a Pfizer drug for treating pancreatic tumors.

May 20, 2011
CRN responds to Lazy Cakes controversy

The Council for Responsible Nutrition on Thursday issued a statement regarding the growing controversy surrounding Lazy Cakes — a brownie containing melatonin, an ingredient that helps establish more normal sleeping patterns — that has been cited in a New York Times article as having “flagrantly mimic[ked] the soothing effects of hash brownies.”

May 20, 2011
Edurant OKed as HIV treatment by FDA

The Food and Drug Administration has approved a new antiretroviral treatment for HIV made by Johnson & Johnson, the agency said Friday.

May 20, 2011
FDA committee recommends approval of Abbott's Trilipix, statin combination

A Food and Drug Administration advisory committee has voted to recommend that the FDA retain approval of an Abbott drug for high cholesterol in combination with a statin.

May 20, 2011
Louisiana seeks to expand pharmacy's ability to immunize patients

The Louisiana State Senate passed legislation that would expand the authority given to pharmacists to administer immunizations.

May 20, 2011
Sandoz looks to market generic Vyvanse

Sandoz is looking to market a generic version of a Shire drug for treating attention deficit hyperactivity disorder.

May 20, 2011
Water Quality and Health Council raising awareness of swimmer's ear with free pool test kits

Swimmer’s ear accounts for as many as 2.4 million doctor visits and nearly $500 million in healthcare costs annually, a Centers for Disease Control and Prevention report published Thursday in its "Morbidity and Mortality Weekly Report" found.

May 19, 2011
Avandia to be available only by mail order in November, FDA asserts

A controversial GlaxoSmithKline drug for treating Type 2 diabetes no longer will be available through retail pharmacies as of Nov. 18, the Food and Drug Administration announced Wednesday.

May 19, 2011
CDC warns public on zombies. No, really.

The Centers for Disease Control and Prevention posted an attention-grabbing page Wednesday titled: “Preparedness 101: Zombie Apocalypse.”

May 19, 2011
CHPA praises FDA committees' decision to mandate weight-based dosing of APAP for children

Two Food and Drug Administration advisory committees on Wednesday unanimously voted in favor of mandating weight-based dosing for children between the ages of 2 and 12 years who are being administered acetaminophen.

May 19, 2011
NRF launches advocacy campaign to preserve swipe-fee reform

The National Retail Federation on Wednesday launched a 60-day lobbying, grassroots and media campaign aimed at ensuring that a new federal law — which is designed to save retailers and their customers more than $1 billion a month by lowering the “swipe fees" banks charge to process debit card transactions — takes effect in late July as scheduled.

May 19, 2011
Reports: Unabomber alleged suspect in 1982 Tylenol poisonings

Theodore Kaczynski, also known as the Unabomber, allegedly is a suspect in the 1982 Tylenol poisonings in the Chicago area that killed seven people, according to published reports.

May 17, 2011
APhA Foundation taps Mindy Smith as executive director

The philanthropic arm of the American Pharmacists Association has appointed a new executive director.

May 17, 2011
Chain pharmacy lauds efforts for safe use of pediatric acetaminophen products

The National Association of Chain Drug Stores delivered on Tuesday testimony on the safe usage of pediatric acetaminophen products before a joint meeting of the Food and Drug Administration Nonprescription Drugs Advisory Committee and Pediatric Advisory Committee.

May 17, 2011
FDA advisory committee to discuss safety, efficacy of Trilipix

A Food and Drug Administration panel will discuss findings in a clinical trial that has raised concerns about the safety and efficacy of Abbott's cholesterol-lowering drug when it’s combined with similar drugs, according to an FDA announcement.

May 17, 2011
NCPA expresses support of Community Pharmacy Fairness Act of 2011

The National Community Pharmacists Association on Tuesday endorsed the Community Pharmacy Fairness Act of 2011 (H.R. 1839), legislation recently introduced in the House of Representatives by Rep. Anthony Weiner, D-N.Y.

May 17, 2011
Perrigo receives final approval for generic Zantac 150

Perrigo on Monday announced that it has received final approval from the Food and Drug Administration for its abbreviated new drug application for over-the-counter ranitidine 150 (regular and cool mint), a generic version of Zantac 150.

May 16, 2011
APhA encourages seniors to talk to pharmacists

The American Pharmacists Association is marking Older Americans Month by urging seniors to increase their knowledge about medications and wellness by talking to their pharmacists, the group said Monday.

May 16, 2011
FDA to debate pediatric APAP dosing during mid-week advisory committee meeting

The Food and Drug Administration is convening its Nonprescription Drugs Advisory Committee Tuesday and Wednesday to debate mandating weight-based dosing for pediatric medicines containing acetaminophen on the Drug Facts label, as well as the potential expansion of dosing instructions to incorporate children under the age of 2 years old, according to material posted online by the FDA on Friday.

May 16, 2011
FDA warns consumers of counterfeit ExtenZe

The Food and Drug Administration on Friday warned consumers about a counterfeit product represented as "ExtenZe," which is the name of an authentic dietary supplement for male sexual enhancement.

May 16, 2011
Generic, authorized generic of Amrix launched

Drug maker Mylan has launched a generic treatment for muscle spasms, the company said Friday.

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