Content about Pharmaceuticals policy

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.

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

Drug maker Ikaria said Wednesday that the FDA had extended pediatric exclusivity period for the drug Inomax (nitric oxide) from January 2013 to July 2013.

Ikaria said the extension was based on results of a clinical study of the drug in preterm infants with bronchopulmonary dysplasia, a serious condition that results from lung injury.

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.

EDINA, Minn. — 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. The senator said she also is pressing the Food and Drug Administration and the pharmaceutical industry to address a growing shortage of prescription medications, especially drugs for treating cancer.

January 4, 2011

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

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

Par announced the shipment of propafenone SR capsules, a treatment for atrial fibrillation in patients without structural heart disease.

The drug is a generic version of GlaxoSmithKline’s Rhythmol SR, which has annual sales of around $121 million, according to IMS Health.

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.

WOONSOCKET, R.I. — 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.

Universal American’s Part D business currently serves about 1.9 million Medicare PDP members, while CVS Caremark serves roughly 1.2 million Medicare PDP members. This reflects current levels of membership and does not include 2011 auto assignment or the results of the annual enrollment period, which ended Dec. 31, 2010.

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.

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

In its complete response letter, the FDA requested additional safety and efficacy data for the drug, Iluvien (fluocinolone acetonide intravitreal insert), a treatment for diabetic macular edema, a problem that commonly affects people with diabetes.

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.

MUMBAI, India — 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.

WASHINGTON — 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.

The tax applies to branded drug companies with total sales of at least $5 million to government health programs, including Medicare, Medicaid, Tricare and programs administered by the defense and veterans affairs departments.

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.

NEW YORK — One door closes; another door, well, closes. And that appears to be good news for Teva. Recent news that the Food and Drug Administration has rejected the drug maker's application for a new indication for multiple sclerosis drug Copaxone likely will mean the agency will not be so quick to approve a generic version of the drug without requiring a generic company to perform full clinical trials.

December 22, 2010

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

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

Joining PhRMA are Ian Read, Pfizer's president and CEO; Jerzy Gruhn, Novo Nordisk president; Mark Iwicki, Sunovion Pharmaceuticals president and COO; and Staffan Schuberg, Lundbeck president.

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.

DEERFIELD, Ill., and OSAKA, Japan — 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.

NEW YORK — 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."

SILVER SPRING, Md. — 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."

The roundup is an annual highlighting of what the agency considers the most significant generic drug approvals.

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.

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

The two drug makers announced Tuesday the submission for Acurox (oxycodone hydrochloride), an immediate-release tablet for relief of moderate to severe pain.

The tablets use Acura’s aversion technology, designed to deter abuse of the drug by dissolving or crushing the pills.

December 17, 2010

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

WHAT IT MEANS AND WHY IT'S IMPORTANT — Patent settlements between branded and generic drug companies, sometimes called “pay-for-delay” deals, aren’t going away any time soon.

(THE NEWS: Report: Banning 'pay for delay' settlements likely won't happen. For the full story, click here)

December 17, 2010

The Food and Drug Administration has turned down AstraZeneca’s regulatory approval application for a drug to treat heart disease, the drug maker said.

WILMINGTON, Del. — The Food and Drug Administration has turned down AstraZeneca’s regulatory approval application for a drug to treat heart disease, the drug maker said.

The agency sent AstraZeneca a complete response letter requesting additional analyses of data from a clinical study of Brilinta (ticagrelor), but did not request additional studies. The drug is designed to treat acute coronary syndromes.

A complete response letter means that the FDA has completed its review of a drug application, but issues remain that preclude final approval.

December 15, 2010

Tens of millions of Americans have bought medications online without a prescription, according to a new study.

WASHINGTON — Tens of millions of Americans have bought medications online without a prescription, according to a new study.

According to research funded by the Alliance for Save Online Pharmacies and released by The Partnership at DrugFree.org, illegal online pharmacies have sold drugs to 36 million Americans.

December 14, 2010

Legislation to ban patent litigation settlements between branded and generic drug companies appears unlikely to find success, according to published reports.

NEW YORK — Legislation to ban patent litigation settlements between branded and generic drug companies appears unlikely to find success, according to published reports.

The Hill, a newspaper that covers Congress, reported on Sunday that language in the Senate appropriations bill that would ban so-called “pay for delay” settlements between drug makers did not appear likely to pass. The newspaper reported that the Senate appeared likely to support a resolution supported by the House that did not contain the language.

December 13, 2010

The Food and Drug Administration on Friday warned consumers not to use Man Up Now capsules, which are marketed as a dietary supplement for sexual enhancement, because they contain a variation of an active drug ingredient found in Viagra that can dangerously lower blood pressure.

SILVER SPRING, Md. — The Food and Drug Administration on Friday warned consumers not to use Man Up Now capsules, which are marketed as a dietary supplement for sexual enhancement, because they contain a variation of an active drug ingredient found in Viagra that can dangerously lower blood pressure.

December 13, 2010

Drug maker Shire has filed a patent infringement suit against Watson Pharmaceuticals and Impax Labs in response to their attempt to win approval from the Food and Drug Administration for a generic version of a Shire drug.

DUBLIN — Drug maker Shire has filed a patent infringement suit against Watson Pharmaceuticals and Impax Labs in response to their attempt to win approval from the Food and Drug Administration for a generic version of a Shire drug.

Shire announced that it had filed the suit in the U.S. District Court for the Northern District of California following the two generic drug makers’ filing of an approval application for guanfacine hydrochloride, a version of Shire’s Intuniv, used to treat hypertension.

December 13, 2010

More retailers have joined UnitedHealthcare's prescription savings program that caters to Medicare Part D members.

MINNETONKA, Minn. — More retailers have signed on for UnitedHealthcare's prescription savings program that caters to Medicare Part D members.

Target, H-E-B, Hy-Vee, Publix Super Markets, Food Lion, Bloom, Harveys and Sweetbay Supermarket have joined the insurance company's Pharmacy Saver program, which allows members to purchase some scripts for $2 for 30-day and some 90-day supplies, and applies to hundreds of prescription drugs, including 8-of-the-10 most commonly used by UnitedHealthcare Medicare plan members.

December 10, 2010

The National Association of Chain Drug Stores on Friday released a ready-made pamphlet and sign for its retail members to use in communicating upcoming flexible spending account changes as they relate to over-the-counter medicines.

ALEXANDRIA, Va. — The National Association of Chain Drug Stores on Friday released a ready-made pamphlet and sign for its retail members to use in communicating upcoming flexible spending account changes as they relate to over-the-counter medicines.

December 10, 2010

Most beneficiaries of the Medicare Part D program are unaware of new measures to close the so-called “donut hole” coverage gap, according to a recent poll.

WASHINGTON — Most beneficiaries of the Medicare Part D program are unaware of new measures to close the so-called “doughnut hole” coverage gap, according to a recent poll.

December 9, 2010

Amneal Pharmaceuticals has named a drug industry attorney as SVP and general counsel, the generic drug maker said Thursday.

BRIDGEWATER, N.J. — Amneal Pharmaceuticals has named a drug industry attorney as SVP and general counsel, the generic drug maker said Thursday.

Amneal announced the appointment of Robert Loewenstein, who previously served as head of law firm Budd Larner, P.C.’s corporate generic pharmaceuticals practice.

December 7, 2010


BENTONVILLE, Ark. — It’s the kind of low-price power play that gives smaller-scale independent pharmacy owners — and chain drug store operators too, for that matter — the willies. In what promises to be another potent and potentially market-altering exercise in massive scale and competitive clout, Walmart has linked up with insurance heavyweight Humana to launch what it says will be the lowest-cost prescription drug plan for seniors who rely on Medicare Part D prescription drug coverage.