Content about Sulfoxides

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.

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.

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.

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.

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.

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:

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.

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.

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.

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.