Content about Regulatory and Washington

February 28, 2011
NRF to Federal Reserve: Swipe card fee cap doesn't go far enough

The National Retail Federation last week responded to the Federal Reserve's proposal to cap debit card swipe fees at 12 cents per transaction.

February 28, 2011
Once again, Shire seeks FDA approval for Firazyr

British drug maker Shire again is trying to win approval for a hereditary angioedema drug that the Food and Drug Administration had previously declined to approve.

February 28, 2011
Takeda's Edarbi approved as hypertension treatment

The Food and Drug Administration has approved a new treatment for hypertension, also known as high blood pressure, the agency said Friday.

February 25, 2011
Life…supplemented kicks off 'Why You Want to Be Well' initiative

Life…supplemented on Thursday announced its fundraising initiative, “Why You Want to Be Well,” for Vitamin Angels for March, and will use Facebook to raise up to $5,000.

February 25, 2011
Protalix receives CRL for Gaucher disease treatment

The Food and Drug Administration has declined to approve a biologic treatment for a rare genetic disorder by Israeli drug maker Protalix Biotherapeutics, Protalix said Friday.

February 25, 2011
Watson seeks regulatory approval for generic Adderall XR

Watson Labs is hoping to be the first to market a generic version of a popular drug for attention deficit hyperactivity disorder.

February 24, 2011
Novo Nordisk develops treatment for rarest bleeding disorder, seeks FDA approval

Novo Nordisk has filed for approval of a treatment for a rare genetic bleeding disorder, the Danish drug maker said Wednesday.

February 24, 2011
Takeda seeks FDA approval for hypertension treatment

Drug maker Takeda has filed for regulatory approval of a drug to treat hypertension, the company said Wednesday.

February 24, 2011
Welch promoted to VP scientific and regulatory affairs at NPA

The Natural Products Association on Wednesday announced the promotion of Cara Welch to VP scientific and regulatory affairs.

February 23, 2011
Amid counterfeit product warning, Biotab recalls two lots of Extenze

Biotab Nutraceuticals on Tuesday initiated a voluntary recall of two lots of Extenze nutritional supplement tablets.

February 23, 2011
N.J. governor: Changing Medicaid Rx will help save $41 million

A group representing the nation's pharmacy benefit managers is responding to a proposal made by New Jersey governor Chris Christie that seeks to modernize the state's Medicaid program.

February 23, 2011
Onglyza gets label update

The makers behind a popular Type 2 diabetes treatment have included data from two clinical studies in an update to the drug's prescribing information.

February 23, 2011
Report: North Dakota pharmacy ownership bill defeated

A House bill that would have paved the path for chain and big-box pharmacy retailers to set up shop in North Dakota was rejected on Tuesday, according to a local news report.

February 22, 2011
GPhA announces executive committee, board of directors

The Generic Pharmaceutical Association has elected its 2011 executive committee and board of directors, the generic drug industry trade group announced. As part of a reorganization last year, the board has been reduced to 12 members.

February 22, 2011
Hi-Tech Pharmacal receives market exclusivity for generic Neurontin

Generic drug maker Hi-Tech Pharmacal has received Food and Drug Administration approval for its version of a drug used to treat neurological disorders, the company said Tuesday.

February 22, 2011
Perrigo files regulatory application for Taclonex generic

Generic drug maker Perrigo has filed for approval of a drug to treat psoriasis with the Food and Drug Administration.

February 22, 2011
Report: Arkansas considers switching PSE to Rx only

Arkansas on Friday became the fourth state this year to entertain making the popular decongestant pseudoephedrine available only by prescription.

February 18, 2011
CHPA, Congress propose dose of clarity for kids

HUNTINGTON, N.Y. — Concerns over kids’ medicines and proper dosing is still a prominent issue. Children between the ages of 2 years and 12 years are inaccurately dosed up to 73% of the time, according to a report published by the American Medical Association. This increases emergency room visits in two-thirds of the cases.

February 18, 2011
FDA OKs Corifact

The Food and Drug Administration has approved a treatment for a rare bleeding disorder.

February 18, 2011
FDA wants terbutaline to carry boxed warning label

An asthma drug widely available as a generic should not be used for preventing or treating preterm labor in pregnant women, the Food and Drug Administration warned.

February 18, 2011
First half of cold season ends with H1N1 hangover

All the hype around H1N1 
that was so prevalent in 2009 is gone, leaving only the tough comparisons a year later.

February 18, 2011
Impax granted FDA approval for generic Adoxa

A generic drug maker received regulatory approval from the Food and Drug Administration for its generic version of a bacterial infection treatment.

February 18, 2011
Industry advocates tout
 increase in generics use

Generic drug usage already has been on the rise year after year, with no sign of slowing down. As Jody Fisher, VP marketing for healthcare analytics at market research firm SDI, has told Drug Store News, generics accounted for more than 70% of products dispensed at retail pharmacies and are set to increase further this year.


February 18, 2011
NACDS, NCPA call pharmacy 'backbone of Medicaid's drug benefit'

The National Association of Chain Drug Stores and the National Community Pharmacists Association on Friday sent a joint letter to every governor and state Medicaid director on the importance of pharmacies in Medicaid and the industry’s interest in working with state governments to cut costs.

February 18, 2011
Pa. supermarkets beat archaic liquor laws, expand beer, wine

HARRISBURG, Pa. — The Pennsylvania Supreme Court in December ruled in favor of Wegmans and supermarkets across the state over whether or not the grocers could sell beer on their premises — the ruling expands what many consider to be the most restrictive alcohol distribution laws in the country. 


In Pennsylvania, beer can be purchased only from a restaurant/bar or beer distributor. Beer distributors can sell only by the case or keg, while restaurants and bars cannot sell more than 16 12-oz. beers per purchase. 


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