Content about Sulfoxides

April 18, 2011

A letter educating healthcare providers regarding a drug-drug interaction between prescription anticlotting drug Plavix (clopidogrel) and a proton-pump inhibitor has resulted in a reduction in the number of patients combining the two therapies, according to a new study by Prime Therapeutics released Monday.

ST. PAUL, Minn. — A letter educating healthcare providers regarding a drug-drug interaction between prescription anticlotting drug Plavix (clopidogrel) and a proton-pump inhibitor has resulted in a reduction in the number of patients combining the two therapies, according to a new study by Prime Therapeutics released Monday.

April 5, 2011

Generic drug maker Impax Labs is hoping to become the first to market a version of a gastroesophageal reflux disease treatment made by Takeda Pharmaceutical.

HAYWARD, Calif. — Generic drug maker Impax Labs is hoping to become the first to market a version of a gastroesophageal reflux disease treatment made by Takeda Pharmaceutical.

Impax said Tuesday that it had filed an approval application with the Food and Drug Administration for dexlansoprazole delayed-release capsules in the 30-mg and 60-mg strengths. The drug is a version of Takeda’s Dexilant.

April 5, 2011

Studies have indicated that proton-pump inhibitors, used for treating gastroesophageal reflux disease, reduce the efficacy of a popular blood-thinning drug, but Takeda Pharmaceuticals North America announced on Tuesday the results of a new study indicating that its own PPIs may have less of an effect.

NEW ORLEANS — Studies have indicated that proton-pump inhibitors, used for treating gastroesophageal reflux disease, reduce the efficacy of a popular blood-thinning drug, but Takeda Pharmaceuticals North America announced on Tuesday the results of a new study indicating that its own PPIs may have less of an effect.

April 4, 2011

PL Developments on Monday announced that it has acquired the exclusive rights to sell and distribute store-brand over-the-counter versions of omeprazole sodium bicarbonate capsules, the generic version of Merck’s Zegerid OTC.

WESTBURY, N.Y. — PL Developments on Monday announced that it has acquired the exclusive rights to sell and distribute store-brand over-the-counter versions of omeprazole sodium bicarbonate capsules, the generic version of Merck’s Zegerid OTC.

Par Pharmaceutical currently has approval for the prescription product and has filed for the OTC version. Upon FDA approval and upon favorable resolution of intellectual property litigation, PL Developments will begin marketing the new store-brand proton-pump inhibitor, the company stated.

March 30, 2011

Canadian drug maker Valeant Pharmaceuticals has proposed to buy Cephalon for $5.7 billion, Valeant said Tuesday.

MISSISSAUGA, Ontario — Canadian drug maker Valeant Pharmaceuticals has proposed to buy Cephalon for $5.7 billion, Valeant said Tuesday.

The buyout offer, equal to $73 per share, includes a 29% premium over Cephalon’s stock price. Valeant noted it had made previous offers, but was “disappointed by Cephalon’s unwillingness to engage in discussions in a timely manner.”

March 25, 2011

A pill developed by AstraZeneca and Pozen that combines a nonsteroidal anti-inflammatory drug with a proton-pump inhibitor was well-tolerated in patients with osteoarthritis, according to a new study.

NATIONAL HARBOR, Md. — A pill developed by AstraZeneca and Pozen that combines a nonsteroidal anti-inflammatory drug with a proton-pump inhibitor was well-tolerated in patients with osteoarthritis, according to a new study.

AstraZeneca announced results of PN400-304, a 12-month study of Vimovo (naproxen and esomeprazole magnesium) delayed-release tablets in patients with osteoarthritis who need daily treatment with NSAIDs but are at risk of NSAID-related gastric ulcers. Vimovo is designed to reduce pain while reducing gastric ulcer risk.

March 2, 2011

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.

SILVER SPRING, Md. — 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.

The reports quoted the FDA as saying that in a quarter of cases of proton-pump inhibitors depleting magnesium from the body, use of magnesium supplements did not bring levels back to normal, and use of the drugs had to be stopped.

February 10, 2011

Actavis has received approval from the Food and Drug Administration to market a generic version of a popular gastroesophageal reflux disease treatment.

MORRISTOWN, N.J. — Actavis has received approval from the Food and Drug Administration to market a generic version of a popular gastroesophageal reflux disease treatment.

The generic drug maker said it would market pantoprazole sodium delayed-release tablets in the 20-mg and 40-mg strengths. The drug is the generic equivalent of Pfizer's Protonix, which had U.S. sales of approximately $1.6 billion for the 12 months ended Dec. 31, 2010, according to IMS Health.

Actavis said it would distribute the drug soon.

February 2, 2011

The Food and Drug Administration declined to approve a drug made by Eisai for treating gastroesophageal reflux disease, Eisai said Tuesday.

WOODCLIFF LAKE, N.J. — The Food and Drug Administration declined to approve a drug made by Eisai for treating gastroesophageal reflux disease, Eisai said Tuesday.

The drug maker announced its receipt of a complete response letter from the agency for its application for rabeprazole sodium extended-release capsules, a proton-pump inhibitor for GERD. The FDA delivers a complete response letter when it has finished reviewing a regulatory approval application, but issues remain that preclude final approval of the 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 21, 2011

Indian drug maker Dr. Reddy’s Labs has launched a generic treatment for gastroesophageal reflux disease.

HYDERABAD, India — Indian drug maker Dr. Reddy’s Labs has launched a generic treatment for gastroesophageal reflux disease.

The company announced Thursday the launch of pantoprazole sodium delayed-release tablets in the 20-mg and 40-mg strengths. The drug is a version of Protonix, made by Wyeth, now part of Pfizer.

Pantoprazole sodium delayed-release tablets had sales of around $1.8 billion during the 12-month period ended in September 2010, according to IMS Health.

December 22, 2010

The National Advertising Division of the Council of Better Business Bureaus on Tuesday ruled that Procter & Gamble provided reasonable support for claims that Prilosec OTC provides “superior acid control” over a competing product, Prevacid 24HR. However, the NAD recommended P&G discontinue a comparative claim made in a context that doesn’t reference acid control, the review board added.

NEW YORK — The National Advertising Division of the Council of Better Business Bureaus on Tuesday ruled that Procter & Gamble provided reasonable support for claims that Prilosec OTC provides “superior acid control” over a competing product, Prevacid 24HR. However, the NAD recommended P&G discontinue a comparative claim made in a context that doesn’t reference acid control, the review board added.

P&G’s Prilosec OTC claims were challenged by Novartis Consumer Health, maker of Prevacid 24HR. Claims at issue included:

November 15, 2010

Drug maker Takeda Pharmaceuticals is launching a campaign to raise awareness of gastroesophageal reflux disease,...

NEW YORK — Drug maker Takeda Pharmaceuticals is launching a campaign to raise awareness of gastroesophageal reflux disease, the company said Tuesday.

 

Takeda created the website GetToKnowGERD.com to coincide with GERD Awareness Week, which takes place from Nov. 21 to 27. The company also is using the occasion to promote the GERD drug Dexilant (dexlansoprazole).

 

 

October 25, 2010

Procter & Gamble on Tuesday announced the signing of two NFL offensive linemen — New...

CINCINNATI Procter & Gamble on Tuesday announced the signing of two NFL offensive linemen — New York Giants’ David Diehl and Minnesota Vikings’ Anthony Herrera — as spokesmen of the frequent-heartburn remedy Prilosec OTC. The two NFL players will be part of the Prilosec OTC Living Proof campaign to share their heartburn protection stories over the course of the 2010-2011 NFL season.

 

October 24, 2010

The Food and Drug Administration has approved risk evaluation and mitigation strategies for two sleep...

FRAZER, Pa. The Food and Drug Administration has approved risk evaluation and mitigation strategies for two sleep disorder drugs made by Cephalon, the drug maker said.

 

Cephalon announced that the FDA approved the REMS for Nuvigil (armodafinil) and Provigil (modafinil), both used to improve wakefulness in patients with sleep apnea, narcolepsy or shift work disorder.

 

 

October 18, 2010

Dr. Reddy's disclosed on Tuesday it will market a generic peptic ulcer treatment....

HYDERABAD, India Dr. Reddy's disclosed on Tuesday it will market a generic peptic ulcer treatment.

Dr. Reddy's lansoprazole delayed-release capsules will be available in 15-mg and 30-mg strengths, the drug maker said. The capsules are the generic version of Takeda's Prevacid delayed-release capsules.

The FDA approved Dr. Reddy’s abbreviated new drug application for the drug on Oct. 15.

October 17, 2010

The Food and Drug Administration granted approval for Teva's abbreviated new drug application to market...

JERUSALEM The Food and Drug Administration granted approval for Teva's abbreviated new drug application to market a generic version of a drug designed to treat peptic ulcers.

The generic drug maker said that its drug, lansoprazole, is a generic version of Takeda’s Prevacid SoluTab. Annual sales of the branded product were approximately $453 million in the United States, according to IMS sales data.

Sandoz, the generics division of Swiss drug maker Novartis, also announced the launch of its own version of Prevacid SoluTab.

August 12, 2010

The Food and Drug Administration on Aug. 9 posted a video outlining the revised prescription...

SILVER SPRING, Md. The Food and Drug Administration on Aug. 9 posted a video outlining the revised prescription and over-the-counter labels for proton-pump inhibitors that include new safety information about a possible increased risk of fractures of the hip, wrist and spine with the use of these medications.

 

The video is a part of the FDA’s Drug Info Rounds, “a program by pharmacists for pharmacists,” and presented by the Division of Drug Information pharmacists division of FDA.

 

 

July 18, 2010

A U.S. District Court has ruled in favor of two companies who alleged patent infringement...

June 14, 2010

Intellipharmaceutics has filed an abbreviated new drug application for a generic drug designed to treat...

June 6, 2010

When Schering-Plough Consumer Healthcare began distributing its Zegerid OTC in April, the last piece of...

May 24, 2010

Prolonged use of a common class of drugs for treating digestive problems may increase the...

SILVER SPRING, Md. Prolonged use of a common class of drugs for treating digestive problems may increase the risk of bone fractures, the Food and Drug Administration said Tuesday.

The FDA issued a warning to consumers and healthcare professionals based on a review of several epidemiological studies that long-term use of prescription and OTC proton-pump inhibitors or use of the drugs in high doses could increase the risk of fractures of the hip, wrist and spine. Information about the possible risks will be included on revised product labels for PPIs, the FDA said.

May 2, 2010

The Food and Drug Administration has approved a drug by AstraZeneca and Pozen for treating...

March 29, 2010

The Federal Trade Commission’s crusade against patent settlements between branded and generic drug makers moved...

March 29, 2010

The Food and Drug Administration declined to approve a Cephalon drug as a treatment for...