Content about Pharmaceuticals policy

February 1, 2011

Years 2009 and 2010 were up and down for the generic drug industry and its main trade group, the Generic Pharmaceutical Association. On one hand, there were the departures of president and CEO Kathleen Jaeger and member company Teva Pharmaceutical Industries.

January 31, 2011

Nearly half a million people participated in AstraZeneca's prescription savings programs.

WILMINGTON, Del. — Nearly half a million people participated in AstraZeneca's prescription savings programs.

The drug maker reported that it provided $947 million in savings last year to the more than 545,000 patients in the United States who participated. Participation in the AZ&Me prescription savings programs has increased steadily over the past three years, up 7% over 2009 and 19% over 2008, AstraZeneca said.

January 31, 2011

Anticipating regulatory approval, MAP Pharmaceuticals and Allergan will collaborate to promote a drug for treating acute migraine to physicians.

IRVINE, Calif. — Anticipating regulatory approval, MAP Pharmaceuticals and Allergan will collaborate to promote a drug for treating acute migraine to physicians.

The two companies announced the collaboration Monday for Levadex (dihydroergotamine), an inhaled drug. Phase-3 trials for the drug are finished, and MAP plans to submit an approval application for the drug to the Food and Drug Administration in the first half of this year.

January 31, 2011

Mylan has announced its intention to market a version of a painkiller made by Endo Pharmaceuticals and partner company Teikoku Seiyaku ahead of patent expiration.

CHADDS FORD, Pa. — Mylan has announced its intention to market a version of a painkiller made by Endo Pharmaceuticals and partner company Teikoku Seiyaku ahead of patent expiration.

Endo said Monday that Teikoku Seiyaku and U.S. subsidiary Teikoku Pharma USA had received a Paragraph IV certification from Mylan stating the latter’s intention to market a generic lidocaine topical patch. The drug is a generic version of Endo’s and Teikoku’s Lidoderm.

January 31, 2011

Transcept announced Monday that the Food and Drug Administration has classified the drug maker's insomnia treatment as a complete class-2 response, and assigned the drug a Prescription Drug User Fee Act action date for this summer.

POINT RICHMOND, Calif. — Transcept announced Monday that the Food and Drug Administration has classified the drug maker's insomnia treatment as a complete class-2 response, and assigned the drug a Prescription Drug User Fee Act action date for this summer.

Transcept resubmitted its new drug application for Intermezzo (zolpidem tartrate) on Jan. 18 after receiving a complete response letter from the FDA in October 2009. The drug maker said for the completion of the NDA review, the FDA set the PDUFA action date for July 14.

January 27, 2011

Amylin Pharmaceuticals continued to experience losses in sales and profits during fourth quarter 2010 and for the year as a whole, but losses were lower than in 2009, according to financial results released by the drug maker Wednesday.

SAN DIEGO — Amylin Pharmaceuticals continued to experience losses in sales and profits during fourth quarter 2010 and for the year as a whole, but losses were lower than in 2009, according to financial results released by the drug maker Wednesday.

January 27, 2011

The Food and Drug Administration declined to approve a regulatory approval application from British drug maker GlaxoSmithKline concerning a cancer drug, GSK said Wednesday.

LONDON — The Food and Drug Administration declined to approve a regulatory approval application from British drug maker GlaxoSmithKline concerning a cancer drug, GSK said Wednesday.

GSK said the FDA issued a complete response letter for its application seeking approval for Avodart (dutasteride) to reduce the risk of prostate cancer in men at increased risk of developing the disease. The drug already is approved to treat enlarged prostate.

January 26, 2011

Generic drug makers Teva Pharmaceutical Industries and APP Pharmaceuticals have launched their version of a chemotherapy drug, the two companies said Wednesday.

JERUSALEM — Generic drug makers Teva Pharmaceutical Industries and APP Pharmaceuticals have launched their version of a chemotherapy drug, the two companies said Wednesday.

Teva and APP launched gemcitabine hydrochloride injfection in 200-mg and 1-g single-dose vials. The drug is a version of Eli Lilly’s Gemzar, which had sales of about $785 million in the United States in 2010, according to IMS Health. The drug is used to treat cancers of the lungs, pancreas, breasts and ovaries.

January 25, 2011

Teva on Tuesday confirmed its receipt of an action letter from the Food and Drug Administration for its generic blood-thinning drug.

JERUSALEM — Teva on Tuesday confirmed its receipt of an action letter from the Food and Drug Administration for its generic blood-thinning drug.

January 24, 2011

The Food and Drug Administration has approved a treatment for gastroesphageal reflux disease made by a subsidiary of Mylan, the generic drug maker said Monday.

PITTSBURGH — The Food and Drug Administration has approved a treatment for gastroesphageal reflux disease made by a subsidiary of Mylan, the generic drug maker said Monday.

The FDA approved Matrix Labs’ pantoprazole sodium delayed-release tablets in the 20-mg and 40-mg strengths.

The drug is a version of Protonix DR, made by Wyeth, now part of Pfizer. Various versions of the drug had sales of around $1.7 billion during the 12-month period ended in September, according to IMS Health. The FDA also approved a version made by Dr. Reddy’s Labs on Friday.

January 24, 2011

As many as 71% of cough-cold sufferers in search of decongestant relief oppose a prescription requirement for pseudoephedrine, according to a survey commissioned by the Asthma and Allergy Foundation of America released Monday.

WASHINGTON — As many as 71% of cough-cold sufferers in search of decongestant relief oppose a prescription requirement for pseudoephedrine, according to a survey commissioned by the Asthma and Allergy Foundation of America released Monday.

January 21, 2011

Generic drug maker Watson Pharmaceuticals expects sales of $4.2 billion for 2011, the company said Friday.

NEW YORK — Generic drug maker Watson Pharmaceuticals expects sales of $4.2 billion for 2011, the company said Friday.

The company expected the forecasted sales for the year to include between $2.8 billion and $3 billion in global generics sales, compared with around $2.35 billion in 2010. Total sales for 2010 were around $3.5 billion, according to preliminary financial results released last week.

January 20, 2011

Finalizing an acquisition of biotech company Genzyme by French drug maker Sanofi-Aventis “will take some time,” media reports quoted Genzyme’s chief executive as saying.

BOSTON — Finalizing an acquisition of biotech company Genzyme by French drug maker Sanofi-Aventis “will take some time,” media reports quoted Genzyme’s chief executive as saying.

The Boston Globe quoted Genzyme CEO Henri Termeer as saying it would be a long process to understand the company’s full value, in particular because of an investigational multiple sclerosis drug, Campath (alemtuzumab), which could achieve blockbuster sales and thus raise the company’s value and acquisition price if it wins approval.

January 19, 2011

A permanent injunction was granted to the federal government Tuesday against a contract manufacturer and distributor of prescription and over-the-counter products, as well as two of its executives.

SILVER SPRING, Md. — A permanent injunction was granted to the federal government Tuesday against a contract manufacturer and distributor of prescription and over-the-counter products, as well as two of its executives.

January 19, 2011

In response to articles that appeared in several media outlets about its generic drug pipeline, drug maker Impax Labs is looking to set the record straight.

HAYWARD, Calif. — In response to articles that appeared in several media outlets about its generic drug pipeline, drug maker Impax Labs is looking to set the record straight.

The company said several financial websites had reported that Impax had found a way to make a generic version of Pfizer’s cholesterol-lowering drug Lipitor (atorvastatin calcium).

January 18, 2011

Drug database provider First DataBank has appointed former Gold Standard/Elsevier editor-in-chief Karl Matuszewski as VP clinical and editorial knowledge-base services, the company said Tuesday.

SOUTH SAN FRANCISCO, Calif. — Drug database provider First DataBank has appointed former Gold Standard/Elsevier editor-in-chief Karl Matuszewski as VP clinical and editorial knowledge-base services, the company said Tuesday.

In the new role, Matuszewski will guide editorial policy development for the creation and maintenance of First DataBank’s knowledge-base services and disease decision support products, including National Drug Data File Plus, OrderView Med Knowledge Base and related clinical modules.

January 17, 2011

Generic drug maker Teva Pharmaceutical Industries and subsidiary Barr Labs are prohibited from marketing a generic version of an Amgen drug for patients with chronic kidney disease until the drug’s patents expire, under a recent court decision.

THOUSAND OAKS, Calif. — Generic drug maker Teva Pharmaceutical Industries and subsidiary Barr Labs are prohibited from marketing a generic version of an Amgen drug for patients with chronic kidney disease until the drug’s patents expire, under a recent court decision.

January 17, 2011

A new drug application for Anglo-Swedish drug maker AstraZeneca's vandetanib has been extended.

LONDON — A new drug application for Anglo-Swedish drug maker AstraZeneca's vandetanib has been extended.

The drug maker recently announced that the Food and Drug Administration asked AstraZeneca to submit a Risk Evaluation and Mitigation Strategy, which accordingly extended the Prescription Drug User Fee Act from Jan. 7 to April 7.

AstraZeneca will continue to work closely with the FDA to support the review of vandetanib, a drug for treating patients with advanced medullary thyroid cancer.

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.

ST. LOUIS — 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.

K-V, which acquired the injected drug Gestiva (hydroxyprogesterone caproate) from Hologic in 2008, said Hologic originally had been told the FDA would take action Thursday.

K-V said it was confident the drug would receive approval and that the FDA would take action on or before the new PDUFA date.

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.

BOSTON — 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.

The CSDD called the study the first systematic look at REMS since the FDA introduced the program in 2008. The FDA requires drug companies to create a REMS when the agency decides it is necessary to ensure that a drug’s benefits outweigh its risks.

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.

ALEXANDRIA, Va. — 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.

DEERFIELD, Ill. — 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.

WOONSOCKET, R.I. — 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.

WHAT IT MEANS AND WHY IT'S IMPORTANT — 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.

(THE NEWS: CVS Caremark acquires Universal American. For the full story, click here)

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.

SILVER SPRING, Md. — 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.