Content about Regulatory and Washington

April 21, 2011
Watson confirms Welchol patent challenge

Watson Pharmaceuticals is hoping to become the first company to market a generic treatment for cholesterol.

PARSIPPANY, N.J. — Watson Pharmaceuticals is hoping to become the first company to market a generic treatment for cholesterol.

The drug maker said Wednesday that it had filed with the Food and Drug Administration for approval of a generic version of Welchol (colesevelam hydrochloride) tablets in the 625-mg strength, made by Daiichi Sankyo, thus challenging the patents covering the drug.

April 20, 2011
Government agencies draft plan to curb opioid abuse

The Obama administration is looking to curb the growing national epidemic of prescription painkiller abuse, according to a plan unveiled Tuesday.

WASHINGTON — The Obama administration is looking to curb the growing national epidemic of prescription painkiller abuse, according to a plan unveiled Tuesday.

Elements of the plan include expansion of state-based prescription drug monitoring programs, recommendation of convenient and environmentally responsible drug-disposal methods, education and reduction of doctor shopping.

April 20, 2011
J&J: McNeil production to slow down

Johnson & Johnson on Tuesday announced that distribution of McNeil Consumer Healthcare consumer products will slow in the coming months as the company shifts production of its over-the-counter medicines to other manufacturing plants and implements additional third-party quality controls within those plants.

NEW BRUNSWICK, N.J. — Johnson & Johnson on Tuesday announced that distribution of McNeil Consumer Healthcare consumer products will slow in the coming months as the company shifts production of its over-the-counter medicines to other manufacturing plants and implements additional third-party quality controls within those plants.

April 20, 2011
John Coster joins NCPA, heads up new advocacy center

The National Community Pharmacists Association on Wednesday named longtime industry veteran John Coster as SVP government affairs and head of the association’s newly created NCPA Advocacy Center.

ALEXANDRIA, Va. — The National Community Pharmacists Association on Wednesday named longtime industry veteran John Coster as SVP government affairs and head of the association’s newly created NCPA Advocacy Center.

The NCPA Advocacy Center will unite the association’s government affairs, grassroots, pharmacy benefit manager transparency, professional affairs and public affairs programs to enhance NCPA advocacy efforts and ensure that they have the maximum impact possible.

April 20, 2011
Mylan launches generic Famvir

Mylan has launched a generic drug for treating herpes, the company said Wednesday.

PITTSBURGH — Mylan has launched a generic drug for treating herpes, the company said Wednesday.

Mylan announced the launch of famciclovir tablets in the 125-mg, 250-mg and 500-mg strengths. The drug is a generic version of Novartis’ Famvir.

Branded and generic versions of the drug had sales of $196 million in 2010, according to IMS Health.

April 20, 2011
NACDS expands state government affairs team

The National Association of Chain Drug Stores announced on Wednesday that Joel Kurzman has joined its state government affairs team as a director.

ALEXANDRIA, Va. — The National Association of Chain Drug Stores announced on Wednesday that Joel Kurzman has joined its state government affairs team as a director.

April 20, 2011
Rituxan OKed as treatment for two inflammatory diseases

The Food and Drug Administration has approved a drug made by Genentech for the treatment of two rare inflammatory disorders, the agency said.

SILVER SPRING, Md. — The Food and Drug Administration has approved a drug made by Genentech for the treatment of two rare inflammatory disorders, the agency said.

April 19, 2011
BIO's Rosado joins FMI

The Food Marketing Institute said Tuesday that it has appointed Robert Rosado as director of government relations.

ARLINGTON, Va. — The Food Marketing Institute said Tuesday that it has appointed Robert Rosado as director of government relations.

According to FMI, Rosado will focus on legislation that impacts supermarkets in the areas of food safety, health care, food deserts and the 2012 Farm Bill.

“Rob has a broad range of expertise in food and agriculture that will be very helpful to FMI and its members. His background also includes working with federal agencies on many issues related to the food retail industry,” FMI president and CEO Leslie Sarasin said.

April 19, 2011
CRN, ASN honor two researchers for work in supplement industry

The Council for Responsible Nutrition and the American Society for Nutrition on Monday recognized two researchers for their work in the supplement industry.

WASHINGTON — The Council for Responsible Nutrition and the American Society for Nutrition on Monday recognized two researchers for their work in the supplement industry.

Xiang-Dong Wang and Mario Ferruzzi were awarded the Mary Swartz Rose Senior Investigator Award and the Mary Swartz Rose Young Investigator Award, respectively, at ASN’s Scientific Sessions and Annual Meeting.

April 19, 2011
Forest purchases rights to azimilide

Drug maker Forest Labs has acquired worldwide rights to a drug developed by Procter & Gamble Pharmaceuticals for treating arrhythmia.

NEW YORK — Drug maker Forest Labs has acquired worldwide rights to a drug developed by Procter & Gamble Pharmaceuticals for treating arrhythmia.

Forest said Tuesday that it had purchased the rights to azimilide from Blue Ash Therapeutics and had been assigned a license agreement between Blue Ash and Warner Chilcott. Forest will assume responsibility for all future development and commercialization, including costs. Financial terms of the deal were not disclosed.

April 19, 2011
GPhA applauds new IMS Institute report

The main trade group for the generic drug industry is heralding a new cost analysis by the IMS Institute for Healthcare Informatics showing that generic drugs can reduce co-payments by up to 80%.

WASHINGTON — The main trade group for the generic drug industry is heralding a new cost analysis by the IMS Institute for Healthcare Informatics showing that generic drugs can reduce co-payments by up to 80%.

According to the analysis, contained in the report “The Use of Medicines in the United States: Review of 2010,” the average co-payment for a generic drug was $6.06 per prescripton last year, compared with $23.65 to $34.77 for preferred and nonpreferred brand drugs.

April 19, 2011
NACDS launches mobile app for Annual Meeting

The National Association of Chain Drug Stores announced on Tuesday the launch of its 2011 Annual Meeting mobile Web-based application, which is designed to enhance attendees' efficiency and experience at the NACDS Annual Meeting from April 30 to May 3 in Scottsdale, Ariz.

ALEXANDRIA, Va. — The National Association of Chain Drug Stores announced on Tuesday the launch of its 2011 Annual Meeting mobile Web-based application, which is designed to enhance attendees' efficiency and experience at the NACDS Annual Meeting from April 30 to May 3 in Scottsdale, Ariz.

In addition, the NACDS mobile website, m.NACDS.org, has been updated with information about the Annual Meeting and all 2011 NACDS events.

April 19, 2011
Sigma-Tau OKed to manufacture primary ingredient in Oncaspar

The Food and Drug Administration has given approval to Sigma-Tau Pharmaceuticals to manufacture the main ingredient of a treatment for leukemia, the drug maker said.

GAITHERSBURG, Md. — The Food and Drug Administration has given approval to Sigma-Tau Pharmaceuticals to manufacture the main ingredient of a treatment for leukemia, the drug maker said.

Sigma-Tau was approved to manufacture L-asparaginase, the primary ingredient in the drug Oncaspar (pegaspargase). Sigma-Tau began seeking approval when the previous manufacturer ceased production. The drug is used to treat acute lymphoblastic leukemia, also known as ALL.

April 18, 2011
Deloitte: Consumers turn to various resources for recall information

Consumers that seek timely and detailed information about product recalls look to multiple resources, according to a new Deloitte survey.

NEW YORK — Consumers that seek timely and detailed information about product recalls look to multiple resources, according to a new Deloitte survey.

April 18, 2011
FDA approves Actemra as arthritis treatment for children

The Food and Drug Administration has approved a drug made by Genentech for treating a rare and severe form of arthritis that affects children, Genentech said.

SOUTH SAN FRANCISCO, Calif. — The Food and Drug Administration has approved a drug made by Genentech for treating a rare and severe form of arthritis that affects children, Genentech said.

The biotech company, the U.S. division of Swiss drug maker Roche, announced the FDA approval of Actemra (tocilizumab) for active systemic juvenile idiopathic arthritis. SJIA has the worst long-term prognosis of all varieties of childhood arthritis.

April 18, 2011
Lilly receives complete response letter for liprotamase

The Food and Drug Administration declined to approve a drug made by Eli Lilly for treating a disease of the pancreas that often occurs in patients with cystic fibrosis, Lilly said.

INDIANAPOLIS — The Food and Drug Administration declined to approve a drug made by Eli Lilly for treating a disease of the pancreas that often occurs in patients with cystic fibrosis, Lilly said.

April 18, 2011
NCPA, Purdue kick off 'Protect Your Pharmacy Week'

The National Community Pharmacists Association and Purdue Pharma announced the start of “Protect Your Pharmacy Week” — a reflection of the Protect Your Pharmacy Now! initiative that began in 2008 to encourage pharmacists to protect their stores, staff and patients against pharmacy crimes, including prescription drug robbery and thefts.

ALEXANDRIA, Va. — The National Community Pharmacists Association and Purdue Pharma announced the start of “Protect Your Pharmacy Week” — a reflection of the Protect Your Pharmacy Now! initiative that began in 2008 to encourage pharmacists to protect their stores, staff and patients against pharmacy crimes, including prescription drug robbery and thefts.

April 18, 2011
Redken recalls spray mousse foam cans

Redken has announced that it is recalling spray mousse foam cans sold at beauty supply stores and hair salons because of potential rupture.

NEW YORK — Redken has announced that it is recalling spray mousse foam cans sold at beauty supply stores and hair salons because of potential rupture.

Over time the aerosol containers' inside lining can corrode, creating the potential risk of rupturing and releasing the contents. Nearly 1 million cans have been recalled, according to the manufacturer.

April 18, 2011
Report: Kansas makes switch to NPLEx system to track pseudoephedrine sales

Kansas on Monday officially made the move from a paper tracking system for pseudoephedrine sales to the electronic tracking capabilities afforded through the National Precursor Log Exchange, according to an Associated Press report published Monday.

TOPEKA, Kansas — Kansas on Monday officially made the move from a paper tracking system for pseudoephedrine sales to the electronic tracking capabilities afforded through the National Precursor Log Exchange, according to an Associated Press report published Monday. Kansas first announced its intent to switch over to NPLEx in March 2010.

April 18, 2011
Taro receives FDA approval for generic Aldara

The Food and Drug Administration has approved a topical treatment for skin conditions made by Israeli generic drug maker Taro Pharmaceutical Industries.

HAWTHORNE, N.Y. — The Food and Drug Administration has approved a topical treatment for skin conditions made by Israeli generic drug maker Taro Pharmaceutical Industries.

Taro announced Monday the approval of imiquimod cream in the 5% strength. The drug is used to treat actinic keratosis and external genital warts, and is a generic version of Graceway Pharmaceuticals’ Aldara.

Imiquimod cream has annual sales of around $340 million in the United States, according to Taro.

April 15, 2011
Abbott Diagnostics seeks FDA approval for vitamin D assay

Abbott Diagnostics on Friday announced its filing of a submission for clearance by the Food and Drug Administration for a fully automated vitamin D assay performed on its Architect testing system for use by healthcare professionals.

ABBOTT PARK, Ill. — Abbott Diagnostics on Friday announced its filing of a submission for clearance by the Food and Drug Administration for a fully automated vitamin D assay performed on its Architect testing system for use by healthcare professionals.

"Increasing interest in vitamin D is fueling a surge in orders for tests as more healthcare professionals and consumers become aware of the rising prevalence of vitamin D deficiencies in otherwise healthy people and the potential health risks," stated Sudarshan Hebbar, senior medical director of Abbott Diagnostics.

April 15, 2011
CDC experts spotlighted in 'Killer Outbreaks'

The Centers for Disease Control and Prevention is participating in a new docudrama that debuts on Animal Planet beginning Friday at 9 p.m., the agency announced earlier this week.

ATLANTA — The Centers for Disease Control and Prevention is participating in a new docudrama that debuts on Animal Planet beginning Friday at 9 p.m., the agency announced earlier this week.

Animal Planet has ordered six episodes of the new series “Killer Outbreaks.” Each episode features potentially deadly viruses and includes commentary from CDC experts and victims of the outbreaks. "Killer Outbreaks" began production in March 2010, and in total, producers interviewed 43 subject matter experts from across the agency.

April 15, 2011
PhRMA honors scientists that helped discover Januvia

The main trade group representing branded drug makers gave an award to two Merck scientists who helped discover an oral medication for Type 2 diabetes.

JERSEY CITY, N.J. — The main trade group representing branded drug makers gave an award to two Merck scientists who helped discover an oral medication for Type 2 diabetes.

April 15, 2011
Takeda's Edarbi enters market

Takeda Pharmaceutical has launched a new treatment for high blood pressure, the company said Friday.

DEERFIELD, Ill. — Takeda Pharmaceutical has launched a new treatment for high blood pressure, the company said Friday.

Takeda announced the launch of Edarbi (azilsartan medoxomil), which the Food and Drug Administration approved on Feb. 25 as a once-daily pill for hypertension.

April 14, 2011
Dr. Reddy's announces market launch of generic OTC Allegra

The Food and Drug Administration has approved Dr. Reddy's version of an allergy medication that recently received Rx-to-OTC switch approval, the generic drug maker said.

HYDERABAD, India — The Food and Drug Administration has approved Dr. Reddy's version of an allergy medication that recently received Rx-to-OTC switch approval, the generic drug maker said.

Dr. Reddy's fexofenadine HCl tablets are bioequivalent versions of Sanofi-Aventis’ Allegra, which received Rx-to-OTC switch approval from the FDA in January.

The fexofenadine HCl Rx market had branded and generic sales of approximately $452 million for the 12 months ended last December, according to IMS Health.