Content about Food and Drug Administration

May 6, 2013
Florida legislature passes biosimilar substitution bill

Florida's state legislature approved a bill last week that will allow pharmacists to substitute biosimilars for brand name biotech drugs.

May 6, 2013
Industry urges FDA to clarify new dietary ingredient notification regulations

The five associations representing the dietary supplement industry on Monday requested that the Food and Drug Administration issue revised guidance on new dietary ingredient notifications, with a specific focus on the information to be included to identify the new dietary ingredient.

May 6, 2013
Pregnant women shouldn't use valproate drugs to prevent migraines, FDA warns

Pregnant women should not use migraine-prevention medications containing valproate sodium due to a higher risk of decreased IQ scores in children, the Food and Drug Administration warned.

May 2, 2013
Justice Department appeals district court ruling removing emergency contraceptive sales restrictions

The Justice Department reported it will appeal a recent judicial decision that would require removing any age restriction from the purchase of the Plan B emergency contraceptive, according to a report published in USA Today.

May 2, 2013
Personal Care Products Council reaffirms safety of lip products

A recently released reported that analyzed and measured the level of metals in 32 lip products does not provide any “new meaningful information” and the traces of metals found were not “unexpected given their natural presence in air, soil and water,” according to a statement issued Thursday by the Personal Care Products Council.

May 1, 2013
FDA approves Plan B One-Step front-end placement for females 15 and older

The Food and Drug Administration announced that it has approved an amended application submitted by Teva Women’s Health to market Plan B One-Step (active ingredient levonorgestrel) for use without a prescription by women 15 years and older.

April 30, 2013
Aurobindo receives FDA approval for hypertension, antibiotic drugs

The Food and Drug Administration has approved two generic drugs made by Aurobindo Pharma, the drug maker said.

April 30, 2013
Drug for rare, fatal genetic disorder receives FDA approval

The Food and Drug Administration has approved a new treatment for a genetic disorder that affects about 500 people in the United States and 3,000 worldwide, the agency said Tuesday.

April 30, 2013
FDA approves anticoagulant-reversal product

The Food and Drug Administration has approved a drug that reverses the effects of anticoagulant drugs in patients who have suffered acute major bleeding, the agency said.

April 30, 2013
FDA approves Genentech arthritis drug for rare disorder in children

The Food and Drug Administration has approved a drug made by Genentech for a rare form of arthritis in children, the company said Tuesday.

April 30, 2013
FDA delays approval of Gilead HIV drugs

The Food and Drug Administration declined to approve two drugs for HIV made by Gilead Sciences for which the company was seeking approval for use as part of treatment regimens.

April 29, 2013
Duchenne muscular dystrophy group launches app

An organization focused on a fatal genetic disorder that affects men has launched a mobile app that allows for the location of clinical trials and clinics.

April 29, 2013
FDA appoints Mary Beth Clarke as director of Office of Executive Programs

A Food and Drug Administration staffer who has led implementation of the Generic Drug User Fee Act has been named to a new director position at the agency, the FDA said Monday.

April 26, 2013
Actavis can launch generic OxyContin in January 2014 under settlement with Purdue

Generic drug maker Actavis is settling a patent-infringement suit with Purdue Pharma concerning the opioid painkiller OxyContin, Actavis said, saying it expected to make more than $100 million in the deal between 2014 and 2015.

April 26, 2013
Obama administration hopes to tackle prescription drug abuse

More than 1.3 million emergency room visits in 2010 were related to abuse of prescription drugs, and the problem has become widespread enough that the Centers for Disease Control and Prevention classifies it as an epidemic. In response, curbing abuse of prescription drugs has become a cornerstone of the Obama administration's drug policy.

April 26, 2013
PhRMA report lists 241 drugs under development for blood cancer

More than 200 drugs for blood cancers are under development, according to a new report by a drug industry trade group.

April 26, 2013
Rogue Internet pharmacies should be primary focus in efforts to secure supply chain

A House Subcommittee on Health hearing Thursday focused on efforts to strengthen the country's pharmaceutical supply chain, and particularly on draft legislation meant to accomplish that.

While often touted as the safest in the world, the U.S. drug supply chain remains vulnerable to counterfeit, adulterated and stolen medications. Given the potentially dangerous risks of using such medicines, it is imperative that they be kept out.

April 25, 2013
Actavis to launch generic ADHD drug in December 2014

Actavis can launch a generic version of an attention deficit hyperactivity disorder drug made by Shire next year under an agreement between the two companies announced Thursday.

April 25, 2013
Mylan marks 25th anniversary of EpiPen's approval by giving it away for free

Mylan Specialty announced Thursday the introduction of a "$0 Co-Pay Offer" on a product used to treat severe allergic reactions.

April 25, 2013
Strengthening of drug supply chain's effects on independent pharmacies raises concerns

The House Committee on Energy and Commerce Subcommittee on Health heard testimony on Thursday morning from representatives of the Food and Drug Administration and several industry trade groups following the introduction of draft legislation that sponsors said would strengthen the country's pharmaceutical supply chain.

April 24, 2013
FDA approves drug for opioid-induced constipation

The Food and Drug Administration has approved a new drug for constipation related to use of opioid painkillers made by Sucampo Pharmaceuticals and Takeda Pharmaceuticals, the drug makers said.

April 24, 2013
Hospira looks to U.S. as it marks European biosimilar milestone

Generic drug maker Hospira marked its fifth year marketing knock-off versions of biotech drugs in Europe Wednesday as it presented at the 2013 Biotechnology Industry Organization International Convention this week.

April 23, 2013
FDA approves second BD Rx generic injectable drug

The Food and Drug Administration has approved a second product in BD's new line of injectable drugs, the company said Tuesday.

April 23, 2013
FDA creates map for finding legal online pharmacies

The Food and Drug Administration has launched an interactive map that allows users to find licensed online pharmacies by searching through states' board of pharmacy databases.

April 23, 2013
Warner Chilcott receives FDA approval for Minastrin 24 FE

The Food and Drug Administration has approved a new contraceptive drug made by Warner Chilcott, the drug maker said.

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