Perrigo gets final FDA approval for generic Prilosec
ALLEGAN, Mich. Perrigo Monday evening announced that the Food and Drug Administration has granted final approval to Dexcel Pharma Technologies for its 20 mg omeprazole delayed-release tablets, which means Perrigo expects to begin shipping generic equivalents to Procter & Gamble’s Prilosec OTC during the first quarter.
“The approval from the FDA is the final regulatory step for this exclusive product launch, which we expect to be the largest product in Perrigo’s 120 year history,” stated Joe Papa, Perrigo chairman and chief executive officer.
Perrigo expects full-year annual sales to fall between $150 million and $200 million.
Prilosec OTC is indicated for the treatment of frequent heartburn and had estimated current annual sales of approximately $750 million in all outlets, Perrigo stated.
Prilosec, Nexium analysis shows no heart disease link
ROCKVILLE, Md. The Food and Drug Administration on Monday affirmed that long-term use of either of the proton-pump inhibitors Prilosec or Nexium was not linked to any increase in the risk of heart disease.
However, the FDA continues to explore a potential increased risk of hip fractures associated with the use of PPIs, FDA officials told reporters this afternoon during a press conference.
“FDA has completed a comprehensive, scientific review of known safety data for the drugs Prilosec and Nexium,” the agency stated. “FDA’s assessment of the information from the data gathered was further supported by an additional analysis of 14 comparative studies of Prilosec, four of which were placebo-controlled. Although these studies were not specifically conducted to assess the risk of heart problems, and patient follow-up was incomplete, they do not suggest an increased risk of heart problems with the use of Prilosec or its newer formulation Nexium.”
The concern over a potential increased risk of heart disease and the use of these PPIs was raised earlier this year when AstraZeneca, manufacturer of both of these PPIs, reported a difference in the frequency of heart attacks and other heart-related problems out of earlier analyses of two small, long-term studies. FDA commissioned a formal safety review of the two drugs in August.
“FDA continues to conclude that long-term use of these drugs is not likely to be associated with an increased risk of heart problems,” the agency stated. “FDA recommends that health care providers continue to prescribe, and patients continue to use, these products as described in the labeling for the two drugs.”
Zerosmoke launches in national retailers, military bases
JUPITER, Fla. Zerosmoke this month launched its drug-free smoking cessation device into several retailers, including Wal-mart, CVS, Rite-Aid and Duane Reade, and Zerosmoke will be available on more than 150 Army, Navy and Marine bases starting shortly after the New Year, the company stated recently.
The Zerosmoke method of quitting smoking is based upon the principle of auricular therapy, or the stimulation of acupressure/acupuncture points in the ear. The product features two small magnets that are placed opposite each other on a determined point of the left ear. This magnetic acupressure therapy slowly eradicates a person’s desire to smoke. The magnets are plated in 24k gold in order to ensure the highest conduction properties and to eliminate allergic reactions.
Zerosmoke is also launching an extensive consumer-advertising campaign, though the company did not quantify its consumer ad budget, that will include national radio and television spots just as many smokers pledge to quit smoking with the new year. “We’re doing in-store marketing with demonstrations for [retailers] like H-E-B,” Maury Winnick, Zerosmoke national sales manager, told Drug Store News. And because the device is drug-free, Zerosmoke is also test-marketing the product against smoking high-school students—students who shouldn’t be able to purchase either tobacco products or any smoking cessation products that contain nicotine. “We found a lot of these kids will pick up and use the product to get away from that [nicotine] addiction. … We’re just starting a marketing program right now to give [Zerosmoke samples] to kids who are smoking.”
And while Zerosmoke can be used as a stand-alone therapy, the company noted, it can also be used in conjunction with other over-the-counter or prescription-drug therapies. “It can be used by people as they are using pills, patches, gum, etc., as an adjunct to those therapies” commented Bryan Frank, Zerosmoke medical consultant. “There is no contra-indication to using [Zerosmoke] as a supplement … to one of the other common therapies.”