FDA switches Nexium 24HR to OTC
NEW YORK — The Food and Drug Administration on Friday approved over-the-counter Nexium 24HR (esomeprazole 20mg), Pfizer announced.
“Switching medicines, whenever appropriate, from prescription to non-prescription status improves access, empowers consumers to care for their own health and is an important strategy for Pfizer,” stated Paul Sturman, president, Pfizer Consumer Healthcare. “The FDA approval of Nexium 24HR is a significant milestone in executing against our plan.”
In 2012, Pfizer acquired exclusive global rights from AstraZeneca to market non-prescription Nexium.
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Sandoz launches generic Prevpac
PRINCETON, N.J. — Sandoz announced the U.S. launch of lansoprazole capsules amoxicillin capsules, USP, and clarithromycin tablets, USP, the generic version of Prevpac.
The drug is used to eliminate the H. pylori infection in patients with duodenal ulcer disease. It’s comprised of amoxicillin and clarithromycin, which are antibiotic medicines, as well as lansoprazole, a proton pump inhibitor that helps decrease production of excess stomach acid, the company said.
“Sandoz is proud to provide a generic version of this important gastro-intestinal therapy,” said Peter Goldschmidt, president of Sandoz. “This launch further expands the Sandoz offering of affordable, high-quality medicines.”
Sandoz will market lansoprazole capsules, amoxicillin capsules, USP, and clarithromycin tablets in the same strengths that Prevpac did. Sales in the United states for branded lansoprazole capsules, amoxicillin capsules, USP, and clarithromycin tablets, USP, totaled approximately $69.7 million for the 12 months ending January 2014, according to IMS Health.
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DSN shines spotlight on the chronic pain patient
DSN recently launched a new microsite, DrugStoreNews.com/Pain-Management, to bring attention to a tragic side of the prescription drug abuse story — one that’s not often told. The millions of Americans who live in chronic pain who already find it difficult to access the medications they need may soon find it even more difficult — because proposed changes in regulatory policy are expected to place additional hurdles on their treatment pathway.
The Food and Drug Administration and the Drug Enforcement Administration have both recommended that combination prescription pain medications containing hydrocodone be reclassified as Schedule II controlled substances. The very real impact of that proposed regulation is the restriction it places on the access of those pain medications to legitimate patients.
These aren’t drug addicts. They don’t doctor shop. They’re not in it for the high. These are real people. They’re your neighbor, in fact, hailing from all walks of life. And the only thing worse than being stigmatized as a criminal pain-pill seeker is the difficulty they already face obtaining appropriate therapy for their chronic pain condition.
The microsite features stories of a man who walked 2,400 miles visiting pain clinics and hospitals along the way to discuss pain with others. Or the story of a former radio personality and present-day pain advocate, who volunteers as the national spokesperson and pain advocate co-chair for IPPU: Intractable Pain Patients United.
For too long, these advocates suffered in silence. They were invisible. And there are more invisible pain sufferers out there than there are people who are, in fact, addicted to pain killers. A lot more. According to the 2012 National Survey on Drug Use and Health, there are 2.1 million people who were addicted to pain pills in the prior year. According to the Institute of Medicine, more than 100 million patients experience chronic pain.
These 2.1 million pain-pill addicts are very visible, however. They’re escapades in obtaining their fix is prominent all over the nightly news to the tune of "something must be done." So DSN is doing something equally prominent — shifting the spotlight from stories of the criminals to stories of the sufferers with the same intensity as the nightly news, because something does need to be done. And in helping to bring attention to many of these stories, DSN not only can serve as an important platform for patient advocacy and policy issues, but also as a conduit for change.
Because the story of the 100 million needs to be told.
Hi, I suffer from chronic pain done by the hands of the very ppl that took an oath to cause no harm. I have been on pain medications for 8 yrs now, and if it were not for these medications, I would not be here now. There are so many that benefit from these medications. Now we are all targets, out of our hands. In Jan. this year I went to CVS to fill my monthly meds as I have done for the past 6 yrs, they totally denied me my medications, during a horrible winter storm with sub zero temps. They gave me no notice, that this was going to be their new rule in December. Why? People that abuse these drugs for high's will always find something to get them high. It really is not fair that us that suffer from horrendous pain, have to be afraid of losing the only thing that keeps them living a somewhat normal life. Recently in Indiana, they made a new law, the bitter pill law, my Doctor's office updated the computer systems and now are set up like pain Management, but CVS will not fill scripts from GP's this does not make sense to me at all. I use to go to Pain Management but my pain could not be fixed and my Dr's worked out a plan that I just saw my GP for my refills and my other issues. I am so afraid that one day all the big pharmacies will all follow Walgreens, and CVS. Something must be done to change these fears. I have no problem with the pharmacies knowing my diagnosis or any other reasons they may need as long as I continue to be able to live a little longer..