Content about Lactones

March 7, 2014

It's finally happening. Pfizer has placed the ball at the line of scrimmage. And based on the X's and O's to come out of its Lipitor OTC actual-use study, Pfizer will be making its run with its eye on the ultimate prize — a successful Rx-to-OTC switch of a statin.

Only this time, the Food and Drug Administration may not be as quick to sack Pfizer's switch attempt. With the advances and pervasion of health technology in the self-care space by way of smartphones and tablets; with the evolution of the pharmacist as a healthcare professional able to practice at the top of their license; and with the adoption of diagnostic tests like a cholesterol panel that can be physically administered in the pharmacy, consumers may finally get it right when self-selecting a statin.

Because it's the consumer actual-use studies that have scuttled just about every statin switch attempt in the past. In the last switch of Mevacor, FDA advisory panelists determined the statin was safe enough for the self-care space. And it was effective. It's just that the consumers who would be right for an OTC statin didn't appropriately self-select. And if they can't appropriately self-select, what's the point, really?

It's finally happening. Pfizer has placed the ball at the line of scrimmage. And based on the X's and O's to come out of its Lipitor OTC actual-use study, Pfizer will be making its run with its eye on the ultimate prize — a successful Rx-to-OTC switch of a statin. 

January 9, 2014

Mylan has launched a generic drug for preventing rejection of transplanted organs, the company said Thursday.

PITTSBURGH — Mylan has launched a generic drug for preventing rejection of transplanted organs, the company said Thursday.

The generic drug maker announced the launch of mycophenolic acid delayed-release tablets in the 180-mg and 360-mg strengths. The drug is a generic version of Novartis' Myfortic. As the first company to file a completed regulatory approval application for the generic, Mylan is entitled to 180 days in which to compete exclusively against Novartis' product before the Food and Drug Administration can approve additional generic versions.

July 1, 2013

The Food and Drug Administration has declined to approve a sleeping pill made by Merck & Co., citing issues with dosage.

WHITEHOUSE STATION, N.J. — The Food and Drug Administration has declined to approve a sleeping pill made by Merck & Co., citing issues with dosage.

The drug maker said Monday that it received a complete response letter from the FDA concerning the drug suvorexant, for which it is seeking regulatory approval. A complete response letter means that the agency has finished reviewing its approval application, but questions remain that preclude final approval.

April 18, 2013

A federal court ruling has allowed Actavis to relaunch a generic contraceptive drug, the company said.

PARSIPPANY, N.J. — A federal court ruling has allowed Actavis to relaunch a generic contraceptive drug, the company said.

December 28, 2012

Teva Pharmaceuticals has received approval of their new drug application for topotecan hydrochloride injection, a treatment for small cell lung cancer, according to Food and Drug Administration records.

SILVER SPRINGS, Md. — Teva Pharmaceuticals has received approval of their new drug application for topotecan hydrochloride injection, a treatment for small cell lung cancer, according to Food and Drug Administration records.

July 9, 2012

GlaxoSmithKline on Monday issued an email blast to registrants of its MyAlli.com site that Alli will be making its way back to store shelves later this month.

PITTSBURGH — GlaxoSmithKline on Monday issued an email blast to registrants of its MyAlli.com site that Alli will be making its way back to store shelves later this month.

August 29, 2011

A drug made by Pfizer and Bristol-Myers Squibb undergoing late-stage clinical trials was more effective than the generic drug warfarin in patients with atrial fibrillation, according to study results released Sunday.

NEW YORK — A drug made by Pfizer and Bristol-Myers Squibb undergoing late-stage clinical trials was more effective than the generic drug warfarin in patients with atrial fibrillation, according to study results released Sunday.

The phase-3 "ARISTOTLE" trial of Eliquis (apixaban) showed that the drug reduced the risk of stroke and systemic embolism by 21%, major bleeding by 31% and death by 11% in AF patients. The study, published in the New England Journal of Medicine, was conducted at 1,034 centers in 39 countries and enrolled 18,201 patients.

June 16, 2011

The Food and Drug Administration has approved a new drug for preventing organ rejection in kidney transplant patients, the agency said Wednesday.

SILVER SPRING, Md. — The Food and Drug Administration has approved a new drug for preventing organ rejection in kidney transplant patients, the agency said Wednesday.

The FDA approved Bristol-Myers Squibb’s Nulojix (belatacept), for preventing acute rejection in adult patients. The drug is approved for use with other immune system-suppressing drugs, specifically Novartis’ Simulect (basiliximab), Genentech’s CellCept (mycophenolate mofetil) and corticosteroids.

February 7, 2011

GlaxoSmithKline has received a license extension in Europe for its popular weight-loss pill Alli.

LONDON — GlaxoSmithKline has received a license extension in Europe for its popular weight-loss pill Alli.

The drug maker said it plans to sell new chewable tablets this spring, available at pharmacies throughout the United Kingdom.

Alli has been available in the United Kingdom since early 2009.

August 26, 2010

The Food and Drug Administration has approved a generic treatment for hypertension and liver cirrhosis...

HAUPPAUGE, N.Y. The Food and Drug Administration has approved a generic treatment for hypertension and liver cirrhosis made by Amneal Pharmaceuticals, Amneal said Thursday.

 

The FDA approved Amneal’s spironolactone hydrochloride tablets in the 25 mg, 50 mg and 100 mg strengths. The drug is a generic version of Pfizer’s Aldactone. Various versions of the drug had sales of $91 million in 2009, according to IMS Health.

 

 

July 21, 2010

The National Advertising Division of the Council of Better Business Bureaus has recommended that Millennium...

May 31, 2010

GlaxoSmithKline Consumer Healthcare last week announced it will update the Alli product label to alert...

May 25, 2010

The Food and Drug Administration on Wednesday notified healthcare professionals and patients that it has...

February 24, 2010

Fera Pharmaceuticals has begun shipping the full line of a topical drug for treating eye...

January 25, 2010

Fera Pharmaceuticals has launched a treatment for bacterial infections of the eye, the generic drug...

January 17, 2010

The Food and Drug Administration on Monday issued a warning to consumers about a counterfeit...

August 23, 2009

This agency pulls no punches. The merest blip of a post-marketing serious adverse event report,...

NEW YORK This agency pulls no punches. The merest blip of a post-marketing serious adverse event report, and the agency is acting sooner than later. Because when you get right down to it, out of all the prescriptions for Xenical (approved for sale April 1999), out of all the people who have tried Alli when the ingredient orlistat was switched over the counter (in February 2007), there have been as many adverse events reported in the United States around orlistat and liver injury as there have been Boston Red Sox championships in the past 70 years: two.