Content about Regulatory and Washington

March 4, 2011
Oral contraceptive Emoquette wins FDA approval

A subsidiary of Endo Pharmaceuticals has won approval from the Food and Drug Administration for an oral contraceptive.

March 4, 2011
Vaccine push hits retail

With pharmacists across the country now able to administer vaccinations, the Department of Health and Human Services’ plan came at just the right time.

March 3, 2011
1099 provision of PPACA overturned in House vote

The House of Representatives on Thursday passed the bipartisan Small Business Paperwork Mandate Elimination Act of 2011, which repeals the tax-reporting requirement for small businesses included in the healthcare law.

March 3, 2011
Amneal receives FDA approval for generic Indocin

The Food and Drug Administration has approved a generic drug for pain and inflammatory diseases made by Amneal Pharmaceuticals, Amneal said Thursday.

March 3, 2011
Endo launches Fortesta

Endo Pharmaceuticals has launched a recently approved testosterone gel for men.

March 3, 2011
Merck receives CRL for MS treatment

The Food and Drug Administration declined to approve a Merck KGaA drug designed to treat relapsing-remitting multiple sclerosis.

March 3, 2011
NACDS responds to reimportation legislation

In a letter penned Thursday by the National Association of Chain Drug Stores to Sen. Olympia Snowe, R-Maine, the association stated that while it shares the goal of reducing prescription drug costs, authorizing the reimportation of prescription medications — as sought in S.319, the Pharmaceutical Market Access and Drug Safety Act of 2011 — raises concerns about patient health and safety.

March 3, 2011
NACDS, NCPA express support of new MTM bill

The National Association of Chain Drug Stores and the National Community Pharmacists Association have expressed their support for H.R. 891, the Medication Therapy Management Benefits Act of 2011.

March 3, 2011
Rising gas prices not only factor driving supply chain costs

The National Retail Federation warned federal transportation officials that transportation costs would increase by up to 20% in some cases if a proposal to limit the number of hours truck drivers spend behind the wheel each day goes into effect.

March 2, 2011
Drug makers file suit against Mylan over generic Vivelle-Dot

A group of drug makers have sued Mylan over its attempt to gain Food and Drug Administration approval for a generic menopause drug, Mylan said Tuesday.

March 2, 2011
FDA targets unapproved cough-cold, allergy drugs with Unapproved Drugs Initiative

The Food and Drug Administration has taken action against makers of prescription drugs for cough-cold and allergies that don’t have regulatory approval, the agency said Wednesday.

March 2, 2011
Perrigo announces re-inspection of Allegan, Mich., plant

Following the warning letter it received last April, Perrigo announced that the Food and Drug Administration has arrived at the company's Allegan, Mich.-based facility for re-inspection.

March 2, 2011
Report: FDA warns of long-term PPI use

The Food and Drug Administration is warning that long-term use of a class of drugs for gastroesophageal reflux disease may decrease levels of magnesium in the body and increase the risk of such side effects as seizures and heart rhythm problems, according to published reports.

March 1, 2011
Cold sore treatment Xerese enters market

Meda has launched a new cold sore treatment made by commercialization partner Medivir, Medivir said Tuesday.

March 1, 2011
Forest gets nod for COPD drug

The Food and Drug Administration has approved a treatment for chronic obstructive pulmonary disease made by Forest Labs, the agency said Tuesday.

March 1, 2011
Trial date set for generic Copaxone litigation

Teva on Tuesday said that a trial date has been set for its ongoing patent infringement litigation against several drug makers.

February 28, 2011
GSK granted FDA approval for Promacta

The Food and Drug Administration has approved a GlaxoSmithKline drug for a rare blood disorder, GSK said Friday.

February 28, 2011
Intuniv OKed as add-on therapy to treat ADHD

The Food and Drug Administration has approved a new use for a Shire drug to treat attention deficit hyperactivity disorder, Shire said Monday.

February 28, 2011
Matrix Labs' gabapentin capsules get FDA OK

The Food and Drug Administration has approved a treatment for shingles made by a subsidiary of generic drug maker Mylan.

February 28, 2011
NACDS, NCPA believe Tricare beneficiaries should have right to choose

Two lobbying groups representing the nation's pharmacies are emphasizing how community pharmacies can help lower prescription drug costs, as well as the importance of maintaining the right of military families and veterans to choose where they fill their prescriptions through the Tricare program.

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.

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