Content about Regulatory and Washington

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.

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.

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.

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.

April 15, 2011
Takeda's Edarbi enters market

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

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.

April 14, 2011
FDA: Certain TNF blockers could be linked to rare cancer

The Food and Drug Administration has received reports of a rare and usually deadly cancer in patients using a class of biotech drugs to treat autoimmune and inflammatory diseases, the agency said Thursday.

April 14, 2011
First Dietary Supplement Caucus briefing hosted for the 112th Congress

The congressional Dietary Supplement Caucus held its first briefing for the 112th Congress April 6 to a capacity crowd of 60 House and Senate staffers, the caucus announced Thursday.

April 14, 2011
NACDS to House committee: Pharmacy can help prevent, curb Rx drug diversion

The National Association of Chain Drug Stores submitted on Thursday an official statement to the House of Representatives Energy and Commerce Subcommittee on Commerce, Manufacturing and Trade, highlighting pharmacy's commitment in partnering with law enforcement agencies and other stakeholders to help prevent and combat prescription drug diversion and misuse.

April 14, 2011
NCPA: Pharmacists can help combat Rx drug abuse

Local pharmacists work with patients and law enforcement to combat the abuse of controlled substances and other prescription drugs, but changes to federal policy are needed to allow pharmacists to play a greater role, the National Community Pharmacists Association suggested Thursday in comments submitted to Congress.

April 13, 2011
Diabetes stakeholders discuss how healthcare-reform law affects patients

Healthcare reform has remained a major subject of debate since President Barack Obama signed the Patient Protection and Affordable Care Act last March, but what the law means for diabetes care was the particular focus of a conference call with diabetes stakeholders Tuesday.

April 13, 2011
FDA accepts regulatory application for Bio-T-Gel

The Food and Drug Administration has accepted a regulatory approval application for a topical treatment for low testosterone made by Teva Pharmaceuticals and BioSante Pharmaceuticals, BioSante said Wednesday.

April 13, 2011
FDA advisory committee recommends approval for Pfizer's Sutent

A Food and Drug Administration expert panel has given a favorable vote to a drug made by Pfizer for tumors, Pfizer said Tuesday.

April 13, 2011
Georgia seeks to restrict PSE product sales to pharmacies

A bill passed by the Georgia House of Representatives Tuesday will restrict the sale of products containing pseudoephedrine to only pharmacies — a factor that will eliminate PSE products for sale at any gas stations, convenience stores and mass merchants/supermarkets without a pharmacy.

April 13, 2011
NACDS signs on for Partnership for Patients: Better Care, Lower Costs

The National Association of Chain Drug Stores said that it has signed on as a partner for a new public-private partnership, announced by the Department of Health and Human Services and Centers for Medicare & Medicaid Services, that seeks to improve patient health and lower healthcare costs through the use of community-based care transition programs.

April 13, 2011
NCPA backs bill to enhance pharmacy competition

The National Community Pharmacists Association on Wednesday announced support for the Quality Health Care Coalition Act of 2011 (H.R. 1409), which was introduced last week by House Judiciary Committee ranking member Rep. John Conyers Jr., D-Mich., and Rep. Ron Paul, R-Texas, in an effort to improve the quality of patient care by leveling the playing field between healthcare professionals and insurance companies in the healthcare industry.

April 12, 2011
Perrigo facility cleared by FDA

Perrigo on Tuesday announced that the Detroit office of the Food and Drug Administration has concluded its re-inspection of Perrigo's Allegan facility.

April 12, 2011
Sylatron OKed as add-on melanoma treatment

The Food and Drug Administration has approved a treatment made by Merck for treating skin cancer, Merck said Monday.

April 11, 2011
Impax faces generic Oxycontin patent challenge

Another generic drug maker is seeking to market its version of a popular opioid painkiller.

April 11, 2011
Invega approved as schizophrenia treatment for adolescents

The Food and Drug Administration has approved a drug made by Johnson & Johnson for treating schizophrenia in adolescents.

April 11, 2011
Sandoz gets FDA nod for Altavera

The Food and Drug Administration has approved an oral contraceptive made by Sandoz, the company said Friday.

April 8, 2011
HHS seeks to reduce health disparities

The Department of Health and Human Services on Friday launched two plans aimed at reducing health disparities.

April 8, 2011
Hi-Tech granted tentative approval for generic Levaquin

The Food and Drug Administration has granted tentative approval to a generic antibiotic made by Hi-Tech Pharmacal, the drug maker said Friday.

April 8, 2011
NCPA: Florida’s Medicaid Managed Care pilot program raises concerns

A Georgetown University Health Policy Institute study of Florida’s Medicaid Managed Care pilot program should raise doubts for states considering the use of for-profit managed care companies to reduce Medicaid costs, the National Community Pharmacists Association cautioned on Friday.

April 8, 2011
P&G recalls 10 shades of Clairol Natural Instincts

Procter & Gamble has announced a voluntary recall of 10 shades of its Clairol Natural Instincts in the United States, Canada and Puerto Rico because of a mismatched ColorFresh! Revitalizer sachet in the kits that may create an unwanted color result.

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