Content about Regulatory and Washington

June 10, 2011
Forest announces availability of Daliresp

A drug for chronic obstructive pulmonary disease made by Forest Labs will be available by the middle of this month, Forest said Thursday.

NEW YORK — A drug for chronic obstructive pulmonary disease made by Forest Labs will be available by the middle of this month, Forest said Thursday.

Daliresp (roflumilast) recently received approval from the Food and Drug Administration as a treatment to reduce the risk of exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations.

Forest said Daliresp, a daily oral tablet, is the first and only approved drug in its class, known as selective phosphodiesterase-4 inhibitors.

June 9, 2011
FDA approves labeling change for Eli Lilly insulin product

Patients with Type 1 diabetes using an insulin product made by Eli Lilly can store it in their pumps for longer periods of time, while children using it have additional options, thanks to a labeling change approved Wednesday by the Food and Drug Administration.

INDIANAPOLIS — Patients with Type 1 diabetes using an insulin product made by Eli Lilly can store it in their pumps for longer periods of time, while children using it have additional options, thanks to a labeling change approved Wednesday by the Food and Drug Administration.

June 9, 2011
FDA recommends limiting use of simvastatin in 80-mg strength

The Food and Drug Administration is seeking to limit the use of high doses of a drug for high cholesterol due to the risk of a muscle injury known as myopathy.

SILVER SPRING, Md. — The Food and Drug Administration is seeking to limit the use of high doses of a drug for high cholesterol due to the risk of a muscle injury known as myopathy.

June 9, 2011
HairMax LaserComb Lux 9 OKed to treat female pattern hair loss

Lexington has received clearance from the Food and Drug Administration for marketing the HairMax LaserComb Lux 9 to treat female pattern hair loss, the manufacturer has announced.

NEW YORK — Lexington has received clearance from the Food and Drug Administration for marketing the HairMax LaserComb Lux 9 to treat female pattern hair loss, the manufacturer has announced.

June 9, 2011
NAD to New Nordic US: Discontinue Mulberry Zuccarin dietary supplement ad claims

The National Advertising Division of the Council of Better Business Bureaus earlier this week recommended that New Nordic US modify or discontinue a wide range of advertising claims for the company’s Mulberry Zuccarin dietary supplement product, including claims made in testimonials.

NEW YORK — The National Advertising Division of the Council of Better Business Bureaus earlier this week recommended that New Nordic US modify or discontinue a wide range of advertising claims for the company’s Mulberry Zuccarin dietary supplement product, including claims made in testimonials.

June 8, 2011
Edison's EPI-743 granted orphan drug designation

The Food and Drug Administration has granted orphan drug designation to an investigational treatment made by Edison Pharmaceuticals for rare diseases, Edison said Wednesday.

MOUNTAIN VIEW, Calif. — The Food and Drug Administration has granted orphan drug designation to an investigational treatment made by Edison Pharmaceuticals for rare diseases, Edison said Wednesday.

June 8, 2011
New legislative amendment seeks to kill swipe-fee reforms

Sens. Jon Tester, D-Mont., and Bob Corker, R-Tenn., have offered an amendment to legislation that is designed to delay swipe-fee reforms.

WASHINGTON — Sens. Jon Tester, D-Mont., and Bob Corker, R-Tenn., have offered an amendment to legislation that is designed to delay swipe-fee reforms.

June 8, 2011
Sandoz launches Syeda

The Food and Drug Administration has approved a generic oral contraceptive made by Sandoz, the company said Wednesday.

PRINCETON, N.J. — The Food and Drug Administration has approved a generic oral contraceptive made by Sandoz, the company said Wednesday.

Sandoz, the generics arm of Swiss drug maker Novartis, announced the launch of Syeda (drospirenone and ethinyl estradiol) tablets in the 3-mg/0.03-mg strength.

The drug is a generic version of Bayer HealthCare Pharmaceuticals’ Yasmin. Yasmin and generic versions of the drug had sales of about $365 million during the 12-month period ended in April, according to IMS Health.

June 8, 2011
Swipe-fee reform amendment squashed by Senate

The retail industry won a big victory in Washington, D.C., as the Senate defeated an amendment that proposed to delay swipe-fee reform for another 12 months.

WASHINGTON — The retail industry won a big victory in Washington, D.C., as the Senate defeated an amendment that proposed to delay swipe-fee reform for another 12 months.

June 7, 2011
Actavis granted final approval for generic Ambien CR

The Food and Drug Administration has given final approval to a generic drug for insomnia made by Actavis, the drug maker said Monday.

MORRISTOWN, N.J. — The Food and Drug Administration has given final approval to a generic drug for insomnia made by Actavis, the drug maker said Monday.

The FDA approved the company’s zolpidem tartrate extended-release tablets in the 12.5-mg strength. The drug, which is a Schedule IV controlled substance, is a generic version of Sanofi’s Ambien CR. Actavis was the first company to launch a generic version of the drug in the 6.25-mg strength in October 2010.

June 7, 2011
Dr. Reddy's gets OK for three drugs

Dr. Reddy's Labs has received regulatory approval from the Food and Drug Administration for generic versions of treatments for Alzheimer's disease, depression and breast cancer.

HYDERABAD, India — Dr. Reddy's Labs has received regulatory approval from the Food and Drug Administration for generic versions of treatments for Alzheimer's disease, depression and breast cancer.

The drug maker said that the FDA approved donepezil hydrochloride tablets, a generic version of Pfizer and Eisai's Arciept, in the 5-mg and 10-mg strengths for the treatment of Alzheimer's disease. Both strengths will be available in 30-, 90- and 500-count bottles.

June 7, 2011
FDA seizes probiotic products from UAS Labs

The Food and Drug Administration reported Tuesday that U.S. marshals seized probiotic products from UAS Labs that were being marketed as drugs.

SILVER SPRING, Md. — The Food and Drug Administration reported Tuesday that U.S. marshals seized probiotic products from UAS Labs that were being marketed as drugs.

June 7, 2011
Global Wellness recalls lots of Via Extreme supplement due to presence of undeclared drug

Global Wellness on Tuesday initiated a voluntary nationwide recall of its Via Extreme ultimate sexual enhancer dietary supplement for men.

HOLLYWOOD, Fla. — Global Wellness on Tuesday initiated a voluntary nationwide recall of its Via Extreme ultimate sexual enhancer dietary supplement for men.

The product — a bottle containing six blue-colored capsules per package — was distributed throughout the United States, Puerto Rico and Canada to Internet and retail consumers, the company reported.

Global Wellness is recalling only lots 809013 and 806030; the recall does not affect sales and distribution of Slim Extreme Gold and Gelslim, the company stated.

June 7, 2011
Lannett gets PDUFA date for morphine sulfate oral solution

Generic drug maker Lannett said that the Food and Drug Administration has assigned a Prescription Drug User Fee Act action date for one of Lannett's drugs.

PHILADELPHIA — Generic drug maker Lannett said that the Food and Drug Administration has assigned a Prescription Drug User Fee Act action date for one of Lannett's drugs.

The FDA said it revised its PDUFA goal date of June 23 for Lannett's new drug application for morphine sulfate oral solution.

"With a revised PDUFA date in 17 days, we are preparing for the relaunch of our morphine sulfate oral solution product, if approved,” Lannett president and CEO Arthur Bedrosian said.

June 7, 2011
Mylan subsidiary gets OK for generic Aricept

Another generic drug maker has been given the green light to market its version of an Alzheimer's disease treatment.

PITTSBURGH — Another generic drug maker has been given the green light to market its version of an Alzheimer's disease treatment.

Mylan said that its subsidiary, Matrix Labs, has received final approval from the Food and Drug Administration to manufacture and market donepezil hydrochloride tablets in 5-mg and 10-mg strengths. The drug, a generic version of Pfizer and Eisai's Aricept, is used to treat dementia associated with Alzheimer's disease. Mylan said it will launch the product immediately.

June 7, 2011
Topaz seeks FDA approval for head lice treatment

The Food and Drug Administration has accepted a regulatory approval application for a head lice treatment made by Topaz Pharmaceuticals, Topaz said Tuesday.

HORSHAM, Pa. — The Food and Drug Administration has accepted a regulatory approval application for a head lice treatment made by Topaz Pharmaceuticals, Topaz said Tuesday.

Topaz is seeking approval for ivermectin topical cream, for treating head lice in children and adults.

June 7, 2011
Watson gets FDA nod for generic Lybrel

The Food and Drug Administration has approved a generic contraceptive made by Watson Pharmaceuticals, the company said Tuesday.

PARSIPPANY, N.J. — The Food and Drug Administration has approved a generic contraceptive made by Watson Pharmaceuticals, the company said Tuesday.

Watson announced the approval of levonorgestrel and ethinyl estradiol tablets in the 0.09-mg/0.02-mg strength.

The drug is a generic version of Pfizer’s Lybrel, which had sales of slightly less than $12 million during the 12-month period that ended in April, according to IMS Health.

June 6, 2011
12 generic versions of Femara in market, FDA reports

The Food and Drug Administration has approved a dozen new generic versions of a drug used to treat breast cancer, the agency said Monday.

SILVER SPRING, Md. — The Food and Drug Administration has approved a dozen new generic versions of a drug used to treat breast cancer, the agency said Monday.

The FDA said that on Friday it approved versions of Novartis’ drug Femara (letrozole) made by Teva Pharmaceuticals USA, Dr. Reddy’s Labs, Sun Pharmaceutical Industries, Impax Labs, Endo Pharmaceuticals, Roxane Labs, Accord Healthcare, Synthon Pharmaceuticals, Natco Pharma, Indicus Pharma, Fresenius Kabi Oncology and Kudco Ireland.

June 6, 2011
FDA finds manufacturing issues at Impax's Hayward, Calif., plant

The Food and Drug Administration has found manufacturing issues at a plant owned by generic drug maker Impax Labs, the drug maker said Monday.

HAYWARD, Calif. — The Food and Drug Administration has found manufacturing issues at a plant owned by generic drug maker Impax Labs, the drug maker said Monday.

June 6, 2011
FDA issues statement on E. coli outbreak in Europe

The Food and Drug Administration on Friday addressed the current outbreak of E. coli O104 in Europe.

SILVER SPRING, Md. — The Food and Drug Administration on Friday addressed the current outbreak of E. coli O104 in Europe.

The U.S. regulatory agency said that it has been in "routine contact" with the Centers of Disease Control and Prevention and the European Union to monitor the current outbreak of E. coli O104 and to track any illnesses in the United States that may be related to the outbreak.

June 6, 2011
White House roundtable discussion: Health information technology can help curb Rx abuse

The White House on Friday held a roundtable discussion with approximately two dozen leaders across the public safety, healthcare and technology sectors to address how health information technology can help limit prescription drug abuse, the National Community Pharmacists Association noted in a release on Monday.

ALEXANDRIA, Va. — The White House on Friday held a roundtable discussion with approximately two dozen leaders across the public safety, healthcare and technology sectors to address how health information technology can help limit prescription drug abuse, the National Community Pharmacists Association noted in a release on Monday.

The main focus was how data from prescription drug monitoring programs can better facilitate prescribing, be incorporated into pharmacies and be leveraged in emergency rooms, the association stated.

June 3, 2011
FDA: Wyldewood Cellars' elderberry juice products tout unapproved disease claims

The Food and Drug Administration has seized elderberry juice products that have been distributed by Wyldewood Cellars.

SILVER SPRING, Md. — The Food and Drug Administration has seized elderberry juice products that have been distributed by Wyldewood Cellars.

The FDA said that the products were seized from the Peck, Kan.-based company because they were unapproved, misbranded drugs that violated the agency's Federal Food, Drug and Cosmetic Act by stating that elderberry juice concentrate cures, treats or prevents various disease conditions, including AIDS, diabetes and flu.

The complaint was filed on May 27 in the U.S. District Court of Kansas.

June 3, 2011
Impax confirms patent challenge for generic Detrol

Pfizer has filed suit against generic drug maker Impax Labs in connection with the latter’s attempt to market a generic drug for bladder problems.

HAYWARD, Calif. — Pfizer has filed suit against generic drug maker Impax Labs in connection with the latter’s attempt to market a generic drug for bladder problems.

Impax said Friday that Pfizer filed a patent infringement suit in the U.S. District Court of the District of New Jersey in connection with Impax’s attempt to market a generic version of Detrol (tolterodine tartrate) immediate-release tablets in the 1-mg and 2-mg strengths. The drug is used to treat overactive bladder and urinary incontinence.

June 3, 2011
New flu vaccine will mirror this past season's

The Centers for Disease Control and Prevention said that the Food and Drug Administration has recommended that the flu vaccine for the 2011-2012 season protect against the same strains as it did this year.

WASHINGTON — The Centers for Disease Control and Prevention said that the Food and Drug Administration has recommended that the flu vaccine for the 2011-2012 season protect against the same strains as it did this year.

The FDA's Vaccines and Related Biological Products Advisory Committee recommended that the vaccine will protect those immunized against H1N1, H3N2 and a type of influenza-B virus, the same formulation as this past season's vaccine.

June 3, 2011
Pfizer looks to block Watson from launching generic Viagra

Generic drug maker Watson Labs is hoping to market a generic version of a Pfizer drug for erectile dysfunction.

PARSIPPANY, N.J. — Generic drug maker Watson Labs is hoping to market a generic version of a Pfizer drug for erectile dysfunction.

Watson announced Thursday that it had filed a regulatory approval application with the Food and Drug Administration to market a generic version of Viagra (sildenafil citrate) tablets in 25-mg, 50-mg and 100-mg strengths.