Content about Proton pump inhibitors

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.

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.

ALLEGAN, Mich. — Perrigo has received tentative approval from the U.S. Food and Drug Administration for its abbreviated new drug application to market over-the-counter omeprazole and sodium bicarbonate capsules in the 20-mg/1,100-mg strength, the store-brand equivalent to Merck's Zegerid OTC.

Zegerid OTC (omeprazole and sodium bicarbonate capsules 20 mg/1,100 mg), a proton-pump inhibitor indicated to relieve frequent heartburn, had sales of approximately $42 million through food, drug and mass merchandisers for the lastest 12 months.

NEW YORK — Procter & Gamble this week will begin shipping a wildberry-flavored Prilosec OTC.

The proton-pump inhibitor will not come in a chewable form, however, and will feature the message "Swallow — Do Not Chew" prominently on its packaging.

Procter & Gamble’s Prilosec OTC still is the best-selling antacid on the market, with more than $252.7 million in annual sales for the 52 weeks ended July 8 across food, drug and mass (excluding Walmart), followed by fellow proton-pump inhibitor Novartis’ Prevacid 24HR ($104.1 million).


Both of those antacid heavy hitters are losing dollar share to their generic-
equivalent competitors, however, leaving GlaxoSmithKline’s venerable Tums brand as the largest growth brand within antacids ($91.3 million in sales, up 2.5%).


ALLEGAN, Mich. — Perrigo on Friday announced that it has received final approval from the Food and Drug Administration for its abbreviated new drug application for lansoprazole capsules in the 15-mg strength. The capsules are a generic equivalent of Novartis' Prevacid 24HR capsules.

Sales for Prevacid OTC were approximately $220 million, Perrigo reported.

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SILVER SPRING, Md. — The Food and Drug Administration on Wednesday issued a public warning that the use of proton-pump inhibitors or H2 blockers may be associated with an increased risk of Clostridium difficile–associated diarrhea, or CDAD.

Patients should immediately contact their healthcare professional and seek care if they take PPIs and develop diarrhea that does not improve, the agency stated.

HAMILTON, Ontario — Proton-pump inhibitors may aggravate, not soothe, stomach discomfort created through chronic use of nonsteroidal anti-inflammatory drugs for such conditions as arthritis, according to research released Thursday.

In a study published in the medical journal Gastroenterology, principal investigator John Wallace reported the extent of the hard-to-detect damage caused to the small intestine only recently has been discovered through use of small video cameras swallowed like pills.


Good things come in three — like the three antacids that for the 52 weeks ended April 17 collectively generated more than $118 million in sales on top of the sales base they had established in the year-ago period.


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.

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.