Content about Food and Drug Administration

May 22, 2012
FDA grants regulatory guidance for nail fungus treatment

Drug maker Apricus Biosciences will receive regulatory guidance from the Food and Drug Administration in July that will contain feedback concerning the drug maker's plans to seek approval for a nail fungus treatment.

May 22, 2012
Novo Nordisk's Levemir approved for children ages 2 to 5 years

The Food and Drug Administration has approved a treatment for Type 1 diabetes in children ages 2 to 5 years.

May 21, 2012
Reports: 'Track and trace' may be part of PDUFA reauthorization

Federal and industry officials have been negotiating a federal track-and-trace system as part of a reauthorization of the Prescription Drug User Fee Act, according to published reports.

May 18, 2012
FDA approves generic Parkinson's disease drug made by Actavis

The Food and Drug Administration has approved a treatment for Parkinson's disease made by Actavis, the drug maker said Friday.

May 18, 2012
Perrigo launches store-brand Prevacid 24HR

Perrigo on Friday announced that it has received final approval from the Food and Drug Administration for its abbreviated new drug application for lansoprazole capsules in the 15-mg strength.

May 18, 2012
Watson challenges Lo Loestrin Fe patent

Generic drug maker Watson Pharmaceuticals is challenging the patent protection of a contraceptive drug made by Warner Chilcott, Watson said Friday.

May 17, 2012
FDA approves generic versions of Plavix

The Food and Drug Administration has approved generic versions of one of the country's top-selling drugs made by eight different companies, the agency said Thursday.

May 16, 2012
FDA advisory committee recommends OTC availability of HIV test

OraSure Technologies on Tuesday announced that the Food and Drug Administration's Blood Products Advisory Committee recommended that the OraQuick In-Home HIV test be made available without a prescription.

May 16, 2012
FDA identifies three online products masquerading as dietary supplements

The Food and Drug Administration on Wednesday identified three online products touting "natural" intimacy enhancement that consumers should avoid because they each contain undeclared pharmaceutical ingredients.

May 16, 2012
National Consumers League to FDA: NuVal can mislead consumers

A consumer group is urging the Food and Drug Administration to review a proprietary point-of-purchase nutrition rating system that it said is "inconsistent with FDA guidance statements and enforcement correspondence, federal nutrition programs and recommendations from the Institute of Medicine."

May 16, 2012
ReportersNotebook — Chain Pharmacy, 5/21/12

Watson has announced its intention to acquire Actavis, the company said. Following news reports that the U.S.-based generic drug maker would acquire Switzerland-based Actavis, Watson announced that it would buy the latter for $5.6 billion.

May 16, 2012
Results from phase-3 trial of Pfizer cancer drug disappoint

An experimental kidney cancer drug made by Pfizer didn't extend the time in which patients survived without their disease worsening when compared with a competing drug, according to results of a late-stage clinical trial released Wednesday.

May 15, 2012
Reports: Legislation proposed for biosimilars, overseas drug manufacturers

Legislation proposed in the House of Representatives would speed up Food and Drug Administration approval of knock-off versions of vaccines and other biologics while requiring the agency to conduct more inspections of drug factories overseas, according to published reports.

May 14, 2012
FDA delays new rules for sunscreen makers

Manufacturers of sunscreen now will have six additional months to meet the new labeling and testing requirements as imposed by the Food and Drug Administration, according to an announcement from the Federal Register.

May 14, 2012
FDA panel recommends approval for experimental Gilead HIV drug

A Food and Drug Administration expert panel has recommended approval of a drug made by Gilead Sciences for treating HIV, the drug maker said Friday.

May 11, 2012
'Third class of drugs' could quickly become industry fighting words

There is an important distinction to be made here, one that could place pharmacy operators and over-the-counter manufacturers on opposite sides of the aisle.

May 11, 2012
Amgen offers testimony at FDA biosimilars hearing

Biotech drug maker Amgen has joined the list of companies offering testimony at a Food and Drug Administration hearing on biosimilars Friday.

May 11, 2012
FDA advisory committee recommends PrEP approval for Truvada

An expert panel at the Food and Drug Administration has recommended that the agency approve a drug made by Gilead Sciences for lowering the risk of infection by the virus that causes AIDS.

May 11, 2012
Survey: Consumers would support an OTC test for HIV

As many as 74% of consumers would support a rapid, oral swab HIV test available over the counter, according to a survey released Friday by Who's Positive, a national HIV awareness organization.

May 10, 2012
FDA panel recommends approval for Pfizer RA drug

A Food and Drug Administration expert panel has recommended approval for a drug made by Pfizer for treating rheumatoid arthritis.

May 10, 2012
Watson seeks approval for generic ulcerative colitis drug

Generic drug maker Watson Pharmaceuticals is hoping to be the first to market a generic version of a drug used to treat ulcerative colitis, the company said.

May 9, 2012
Reports: FDA may be close to approving drug for HIV prevention

The Food and Drug Administration may be close to approving a drug for preventing HIV infection, according to published reports.

May 9, 2012
Sandoz to testify at FDA biosimilars hearing

The Food and Drug Administration should apply consistent regulatory standards across all biologics, Sandoz plans to state Friday in testimony at an FDA public hearing on draft guidances related to the development of biosimilars.

May 7, 2012
NACDS expresses to FDA cautious optimism on the 'new paradigm' for third class of drugs

The National Association of Chain Drug Stores submitted on Monday comments to the Food and Drug Administration regarding its position on the “new paradigm” for a third class of drugs.

May 4, 2012
Armada summit's growth in attendance symbolizes growth of specialty channel

A 30% rise in attendance at the Armada Specialty Pharmacy Summit is nothing to brush off — it's as clear an indication as any that specialty pharmacy is growing and probably poised for more growth in the near future, thanks in particular to the aging population and consequential rise in the number of people living with difficult-to-treat medical conditions.

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