Content about Gastroesophageal reflux disease

April 1, 2013
Infants receive GERD medication more often than necessary, study finds

Symptoms associated with gastroesophageal reflux disease are frequently overtreated in infants, according to a new study by researchers in Michigan and Missouri.

ANN ARBOR, Mich. — Symptoms associated with gastroesophageal reflux disease are frequently overtreated in infants, according to a new study by researchers in Michigan and Missouri.

The study, published online Monday in the journal Pediatrics, found that doctors often diagnose such common symptoms in infants as crying and spitting up as disease, and frequent diagnoses of GERD can lead to overuse of medications to treat it, said the researchers at the University of Michigan and the University of Missouri.

March 27, 2013
FDA approves Aciphex Sprinkle capsules

The Food and Drug Administration has approved a treatment made by Eisai for gastroesophageal reflux disease in children ages 1 year to 11 years, the drug maker said.

WOODCLIFF LAKE, N.J. — The Food and Drug Administration has approved a treatment made by Eisai for gastroesophageal reflux disease in children ages 1 year to 11 years, the drug maker said.

Eisai announced the approval of Aciphex Sprinkle (rabeprazole sodium) delayed-release capsules.

January 28, 2013
Amneal, South Korea-based Hanmi enter GERD drug deal

U.S. generic drug maker Amneal Pharmaceuticals has entered a deal with South Korean drug maker Hanmi Pharmaceutical to acquire exclusive distribution rights for a Hanmi drug used for treating gastroesophageal reflux disease, Amneal said Monday.

BRIDGEWATER, N.J. — U.S. generic drug maker Amneal Pharmaceuticals has entered a deal with South Korean drug maker Hanmi Pharmaceutical to acquire exclusive distribution rights for a Hanmi drug used for treating gastroesophageal reflux disease, Amneal said Monday.

December 11, 2012
FDA grants additional market exclusivity to Eisai GERD drug

The Food and Drug Administration is allowing a drug made by Eisai for treating gastroesophageal reflux disease to retain its market exclusivity for six months past the original expiration date, the company said.

WOODCLIFF LAKE, N.J. — The Food and Drug Administration is allowing a drug made by Eisai for treating gastroesophageal reflux disease to retain its market exclusivity for six months past the original expiration date, the company said Tuesday.

Eisai said the FDA had granted six more months of exclusivity for the use of Aciphex (rabreprazole sodium) in children, meaning it will lose market exclusivity on Nov. 8, 2013.

December 4, 2012
FDA accepts application for GERD drug in children

The Food and Drug Administration will review an acid-reflux drug made by Eisai for use in children, the drug maker said.

WOODCLIFF LAKE, N.J. — The Food and Drug Administration will review an acid-reflux drug made by Eisai for use in children, the drug maker said.

Eisai said the FDA accepted its application for AcipHex delayed-release sprinkle capsules in the 5-mg and 10-mg strengths for healing of gastroesophageal reflux disease, and maintenance of healing of GERD and improvement of symptoms in children ages 1 year to 11 years.

The FDA expects to have the application reviewed by March 27, 2013. The drug is currently approved in the 20-mg strength for adolescents and adults.

April 23, 2012
Par buys rights to generic drug for GERD

Par Pharmaceutical has bought rights to a generic drug for gastroesophageal reflux disease from Handa Pharmaceuticals, Par said.

WOODCLIFF LAKE, N.J. — Par Pharmaceutical has bought rights to a generic drug for gastroesophageal reflux disease from Handa Pharmaceuticals, Par said.

Handa, based in Fremont, Calif., sold rights to the regulatory approval application it filed with the Food and Drug Administration for dexlansoprazole capsules, a generic version of Takeda's Dexilant, in the 60-mg strength.

May 26, 2011
AccentHealth announces nine new condition-specific TV networks

A health education television network has added nine condition-specific networks.

NEW YORK — A health education television network has added nine condition-specific networks.

AccentHealth said in addition to its current lineup of four networks, the company will focus its attention on diabetes, heart health, men's health, mental health, senior women's health, rheumatology, allergies, asthma and gastroesophageal reflux disease. These networks will reach and educate more than 13 million patients in doctors' waiting rooms each month through its digitally delivered content, the company said.

April 5, 2011
Takeda: Dexilant, Prevacid have less inhibiting effects on Plavix's efficacy than counterparts

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.

March 23, 2011
Study: GERD sufferers don't discuss symptoms with doctors

Most patients that suffer from gastroesophageal reflux disease or persistent heartburn symptoms rarely speak with a healthcare provider about their condition, according to a new study conducted on behalf of the American Gastroenterological Association, in partnership with drug maker Takeda.

BETHESDA, Md. — Most patients that suffer from gastroesophageal reflux disease or persistent heartburn symptoms rarely speak with a healthcare provider about their condition, according to a new study conducted on behalf of the American Gastroenterological Association, in partnership with drug maker Takeda.

March 2, 2011
Report: FDA warns of long-term PPI use

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 2, 2011
Eisai receives complete response letter for GERD treatment

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 21, 2011
Dr. Reddy's receives FDA approval for generic GERD treatment

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.

November 15, 2010
Takeda launches GetToKnowGERD.com

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).

 

 

July 5, 2010
Lupin gets nod for GERD drug

The Food and Drug Administration has approved a gastroesophageal reflux disease drug made by Lupin...

June 14, 2010
Intellipharmaceutics files new drug application for generic Protonix

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