Content about Food and Drug Administration

March 20, 2013
Doctors, public health experts want more FDA regulation of energy drinks

A group of doctors and public health professors are hoping the Food and Drug Administration will place stronger regulations on energy drinks to protect children and adolescents from what they call the harmful effects of high caffeine consumption.

March 20, 2013
Sandoz launches generic contraceptives

The Food and Drug Administration has approved and launched two generic contraceptives made by Sandoz, the drug maker said.

March 19, 2013
FDA picks acting director for Office of Generic Drugs

The Food and Drug Administration has picked Kathleen Uhl to serve as acting director of the Office of Generic Drugs, the agency said.

March 19, 2013
GAO pushes FDA for final NDI guidance to improve enforcement efforts

The U.S. Government Accountability Office on Monday advised the Food and Drug Administration to establish a time frame on New Dietary Ingredient guidance, as well as guidance clarifying whether a liquid product may be labeled and marketed as a dietary supplement or as a conventional food with added ingredients.

March 19, 2013
Supreme Court to hear generic drug liability case

The question of whether a generic drug company can be held liable for harmful side effects from its medicines goes before the Supreme Court Tuesday in a case involving a New Hampshire woman who sustained several injuries after taking a generic pain drug.

March 18, 2013
FDA approves Mylan bronchospasm drug

The Food and Drug Administration has approved a generic treatment for bronchospasm made by Mylan, the drug maker said Monday.

March 15, 2013
FDA approves new packet version of AbbVie testosterone gel

The Food and Drug Administration has approved a new pocket-sized packet option for a testosterone-replacement therapy made by AbbVie, the drug maker said Friday.

March 15, 2013
PharmaSmart kiosks validated in two independent studies, new clinical integration announced

PharmaSmart International’s comprehensive blood pressure program has recently been validated in two new, independent scientific studies, the company announced today. The company also announced a partnership with Rx-30 Pharmacy System that offers an automated clinical integration of validated PharmaSmart biometrics within the patient record.

March 14, 2013
FDA approves Par generic obsessive compulsive disorder drug

The Food and Drug Administration has approved a drug for obsessive compulsive disorder made by Par Pharmaceutical Cos., the drug maker said Thursday.

March 14, 2013
FDA to review experimental opioid drug

The Food and Drug Administration will decide in late August whether to approve an experimental opioid painkiller made by QRxPharma, the drug maker said Thursday.

March 14, 2013
Increasing use of generics would save money amid sequester, GPhA tells members of Congress

Amid a tide of automatic spending cuts resulting from the failure of Congress and the White House to agree on a budget, the generic drug lobby has offered some suggestions to generate savings.

March 14, 2013
Reports: FDA generic drug chief resigns

The director of the Food and Drug Administration's Office of Generic Drugs is stepping down, according to published reports.

March 14, 2013
SoloHealth named to Georgia’s list of Top 10 Innovative Technology Companies

SoloHealth on Thursday announced it has been selected as one of the Technology Association of Georgia’s Top 10 Innovative Technology Companies. SoloHealth was recognized for its FDA-approved health and wellness kiosk, the SoloHealth Station.

March 12, 2013
Actavis seeks approval for Alzheimer's patch

Actavis is challenging Novartis' patent on a patch used to treat Alzheimer's disease, Actavis said.

March 12, 2013
State, territorial attorneys general call for anti-tampering measures in opioids

The attorneys general of 46 states and two territories are calling on the Food and Drug Administration to make prescription painkillers harder to abuse.

March 8, 2013
Benzocaine warning helps Hyland's sales

Last year the Food and Drug Administration warned parents against using the ingredient benzocaine in children to relieve oral pain.

March 8, 2013
ESI report notes fall in spending on traditional drugs

While the country's spending on specialty drugs increased by 18.4% in 2012, spending on traditional drugs fell for the first time in 20 years, according to a report by Express Scripts.

March 8, 2013
Report: Biosimilars could save $20 billion per year

While the Food and Drug Administration released draft guidance on regulations for biosimilars in February 2012, the final regulations have yet to appear. But already, everyone from analysts to trade groups to drug makers is preparing for a time when knock-off versions of biotech drugs will become available.

March 5, 2013
Actavis seeks approval for testosterone-replacement gel

Drug maker Actavis is challenging the patent for a drug used to treat testosterone deficiency or absence in men, the company said.

March 5, 2013
Amneal ships opioid-dependence drug

Amneal Pharmaceuticals has started shipping a drug used to treat opioid dependence, the company said Tuesday.

March 5, 2013
Dr. Reddy's launches generic cancer drug

Generic drug maker Dr. Reddy's Labs has launched a drug used to treat certain cancers, the company said Tuesday.

March 5, 2013
GPhA defends patent settlements as Supreme Court date nears

The stakes are high in a case involving generic drug maker Actavis and the Federal Trade Commission that will soon go before the Supreme Court, the head of a generic drug industry lobbying group said in a conference call with reporters Tuesday.

March 4, 2013
FDA accepts application for NSAID painkiller

The Food and Drug Administration has accepted a regulatory application for a new painkiller from Iroko Pharmaceuticals, the drug maker said.

March 4, 2013
Reports: FDA investigating more than two-dozen compounding pharmacies

The Food and Drug Administration will inspect about 30 compounding pharmacies that it has deemed "high risk," according to published reports.

March 4, 2013
WSJ: CDC sets stage for a four-strain flu shot for the next flu season

The Centers for Disease Control and Prevention set the stage for the first quadrivalent influenza vaccine to be introduced in the 2013-2014 flu season, according to a report in The Wall Street Journal.

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