January 13, 2011

K-V Pharmaceutical announced Wednesday that the Food and Drug Administration extended its Prescription Drug User Fee Act action date to April 13 for a drug under development for preventing preterm birth.

January 13, 2011

Various companies in the healthcare industry are uncertain about the benefits of the Food and Drug Administration’s risk evaluation and mitigation strategy program, and most think it needs a major overhaul, according to a study by the Tufts University Center for the Study of Drug Development.

January 12, 2011

The independent pharmacy lobby has issued a letter to the House Committee on Oversight and Government Reform chairman, Rep. Darrell Issa, R-Calif., with insight on how certain current or proposed federal regulations can burden pharmacies and their patients.

January 12, 2011

It seems that many mail-order pharmacy patients are unaware that they can receive their 90-day supply of prescription medications at community pharmacies.

January 11, 2011

While a majority of physicians are comfortable with generic medications, there is a small segment who still have negative perceptions about the effectiveness and quality of generic drugs, and that may lead to doctors prescribing unnecessarily expensive medications, according to a new study by researchers at Harvard University, Brigham and Women's Hospital and CVS Caremark.

January 7, 2011

The news that CVS Caremark has entered an agreement to acquire the Medicare Part D business of Universal American is important on several fronts: Not only will the deal more than double the size of CVS Caremark's Medicare Part D program, but the move also comes just as the first baby boomers turn 65.

January 7, 2011

International criminals are posing as Food and Drug Administration special agents and other law enforcement officers in order to extort money from consumers, the FDA warned Friday.

January 6, 2011

The Food and Drug Administration has accepted the approval application for a chemotherapy drug to treat lung cancer from AdventRx Pharmaceuticals, the drug maker said Thursday.

January 6, 2011

The Food and Drug Administration granted priority review to an approval application for a hepatitis C drug made by Merck, the drug maker said Thursday.

January 5, 2011

The Food and Drug Administration has extended by six months the market exclusivity of a lung disease drug for use in children.

January 5, 2011

Supplier News — The Food and Drug Administration has approved a generic drug for hypertension made by Mylan. Mylan announced the approval of nifedipine extended-release tablets in the 30-mg, 60-mg and 90-mg strengths. The drug is a generic version of Bayer’s Adalat CC. Nifedipine tablets had sales of around $82 million during the 12-month period ended June 2010, according to IMS Health.



 

January 5, 2011

Responding to what she termed an “unprecedented” shortage of prescription medicines for such serious conditions as cancer, Sen. Amy Klobuchar, D-Minn., is promising new legislation to deal with the problem.

January 4, 2011

Generic drug maker Par Pharmaceutical has begun shipping its version of a treatment for heart rhythm problems, the company said Monday.

January 3, 2011

CVS Caremark is more than doubling the size of its Medicare Part D program by acquiring the Medicare Part D business of Universal American for roughly $1.25 billion.

January 3, 2011

The Food and Drug Administration declined to approve a treatment for diabetic eye disease made by Alimera Sciences, the drug maker said Dec. 23.

January 3, 2011

The Food and Drug Administration approved three drugs made by Glenmark Generics last month and gave tentative approval to a fourth, the Indian generic drug maker said.

January 3, 2011

The Internal Revenue Service has released its guidance on the healthcare-reform law’s tax on drug makers, according to documents posted on the agency’s website.

December 29, 2010

Recent news that the FDA has rejected Teva's application for a new lower-dose version of multiple sclerosis drug Copaxone likely will hold off the emergence of a generic version of the drug.

December 22, 2010

The Pharmaceutical Research and Manufacturers of America has added four new members to its board.

December 22, 2010

Takeda and its subsidiary settled the patent suits it brought against generic drug makers that sought to develop their own versions of its diabetes treatment.

December 21, 2010

A judge recently blocked AstraZeneca from attempting to impede the development of generic versions of its popular cholesterol drug, according to published reports.

December 20, 2010

Drugs for bacterial infections and cancer, and one that could help shape regulations for biosimilars, are featured in the Food and Drug Administration’s annual "Generic Drug Roundup."

December 20, 2010

Drug makers King Pharmaceuticals and Acura Pharmaceuticals have submitted a regulatory approval application to the Food and Drug Administration for an opioid pain reliever.

December 17, 2010

Patent settlements between branded and generic drug companies, sometimes called “pay-for-delay” deals, aren’t going away any time soon.