This wa cut off the end of the article.
Abuse deterrent formulations are an important tool to help address misuse of medication. In addition, both prescriber and patient education is vital to safe and effective opioid use. FDA encourages all opioid prescribers to take advantage of valuable training, available as of March 1, 2013, to help ensure they have adequate and up-to-date training in opioid therapy. FDA urges all prescribers to ensure patients using opioids are appropriately informed of the risks and benefits of these drugs and fully understand directions for their use. The opioid drug labeling also provides prescriber information related to patient education.
What does this tell you concerning the current attorney general BS ?
That BIG Pharma is behind petitions to not allow competing drugs.
And what did the FDA do.........they said forget about it.
And that is the same thing that is going to take place with this attorney general BS.
This picture is now coming into focus.
Good Luck Longs !
FDA Statement: Original Opana ER Relisting Determination
The U.S. Food and Drug Administration (FDA) today responded to a petition and decided that the original formulation of Opana ER (oxymorphone hydrochloride) Extended-Release Tablets was not withdrawn from the market for reasons of safety or effectiveness. As a result, generic versions of the original formulation can continue to be approved and marketed.
The petition was submitted by Endo Pharmaceuticals Inc., the sponsor of original Opana ER and a reformulated version, also called Opana ER, which was designed with the goal of being more difficult to abuse and misuse. After an extensive, science-based review, FDA concluded based on the available data and information that the original formulation of Opana ER was not withdrawn from the market for reasons of safety or effectiveness. As a result, FDA has denied the manufacturer’s petition.
FDA conclusions include:
While there is an increased ability of the reformulated version of Opana ER to resist crushing relative to the original formulation, study data show that the reformulated version’s extended-release features can be compromised when subjected to other forms of manipulation, such as cutting, grinding, or chewing, followed by swallowing.
Reformulated Opana ER can be readily prepared for injection, despite Endo’s claim that these tablets have “resistance to aqueous extraction (i.e., poor syringeability).” It also appears that reformulated Opana ER can be prepared for snorting using commonly available tools and methods.
The postmarketing investigations are inconclusive, and even if one were to treat available data as a reliable indicator of abuse rates, one of these investigations also suggests the troubling possibility that a higher percentage of reformulated Opana ER abuse is via injection than was the case with the original formulation.
FDA continues to encourage the development of abuse-deterrent formulations of opioids to help reduce
This Is Endo Pharmaceuticals (ENDP) A $7.44 BILLION Market Company with $3 BILLION In Sales
Endo Health Solutions Inc. provides specialty healthcare solutions in the United States and internationally. The companys Endo Pharmaceuticals segment offers branded prescription products, including Lidoderm, Opana ER, Percocet, Voltaren Gel, Frova, Supprelin LA, Vantas, Valstar, and Fortesta Gel for pain, urology, endocrinology, and oncology. Its Qualitest segment provides non-branded generic products in the pain management, urology, central nervous system disorders, immunosuppression, oncology, womens health, and hypertension markets. The companys AMS segment offers various technology solutions comprising AMS 700 MS series, AMS 800 artificial urinary sphincter, GreenLight XPS laser system, Elevate transvaginal pelvic floor repair system, and Monarc subfascial hammock products in the areas of mens and womens health, and BPH therapy. Its HealthTronics segment provides urological services, such as lithotripsy, prostate treatment, anatomical pathology, and electronic medical record services to urologists, hospitals, surgery centers, and clinics; and manufactures, sells, and maintains medical devices for tissue and tumor ablation. The companys products under development primarily include Aveed, an injectable testosterone preparation to treat male hypogonadism; BEMA Buprenorphine, a transmucosal form of buprenorphine in Phase III trials for treating moderate to severe chronic pain; ODM-201, an androgen receptor antagonist in Phase II clinical testing to treat castrate resistant prostate cancer; and EN3342, a polyurethane implant in Phase I/II trials for the maintenance treatment of schizophrenia in adults. It serves pharmacy chains directly; and hospitals, governmental agencies, pharmacies, and physicians through wholesale drug distributors. The company was formerly known as Endo Pharmaceuticals Holdings Inc. and changed its name to Endo Health
August, Bradley S. Galer, MD joined Endo as Vice President, Scientific Affairs. Dr. Galer will provide technical leadership and direction to the departments of Clinical Research, Medical Affairs, and Clinical Development & Education. As the company's senior medical officer, he will be the primary interface between Endo and opinion leaders in pain medicine and will be the primary liaison with the FDA on clinical issues. He will ensure medical/technical support to marketing, will have ultimate responsibility for the evaluation of the safety of Endo's products and will provide medical/technical advice to management. Prior to him joining the company, Dr. Galer was actively involved in the approval of Lidoderm, as both a principal investigator and consultant.
Dr. Galer received his M.D. from Albert Einstein College of Medicine in New York. He served his internship at Kaiser Foundation Hospital, his residency in Albert Einstein's Neurology Program, and Pain Fellowships at both Memorial Sloane-Kettering Cancer Center and University of California San Francisco. He obtained his B.A. in Biology-Psychology at Wesleyan University, Middletown, CT.
Dr. Galer comes to Endo from the Department of Pain Medicine and Palliative Care at Beth Israel Medical Center, New York where he was Director of Clinical Studies and Co-Director, Nerve Pain Disorders Clinic.
Dr. Galer is a founding member of, and was chairman for, the Pain Medicine Section of the American Academy of Neurology over the past two years. He has published over 100 articles and book chapters regarding pain management and pain pharmacotherapy. He is a co-chair of the annual International Neuropathic Pain Conference. In addition, Dr. Galer holds academic memberships in a dozen medical societies, including the International Association for the Study of Pain, The American Academy of Pain Management and the American Academy of Neurology. He was named in the 1998 Best Doctors in America for Pain Management/Neurology.
You actually think we have a problem with WHY the stock is going up?
You better get a new writer, you really suck at bashing.
"Also said that I should look at high-risk stocks, like biotechs, to short... looks like I found what I'm looking for."
Somewhere along the line you must've heard the old saying ....."talk is really cheap".....haven't you?
Grow a set of balls and put your empty hollow words into action.
Faster than a speeding bullet........drd369 gives birth to yet another alias........TODAY !
Too damned ashamed to show his drd369 here after his ad nauseam PREDICTION went awry !
Some very simple common sense questions. Is Zogenix an illegal meth lab, or a legal by the book pharmaceutical company ?
Is Zohydro an illegal drug ? Did the FDA approve an illegal drug ?
The attorney generals that desire the FDA to reneg on their approval of Zohydro, where were they BEFORE much time, effort and MONEY were invested on developing Zohydro?
Why did they NOT speak up in advance ?
Does this set a precedent for companies such as Zogenix, go ahead spend possibly ten years and possibly BILLIONS to develop a drug or medical device, us attorney generals will decide after the fact if we approve ?
The FDA be damned ?
Should all pharmaceutical companies, biotech and medical device companies go to ALL attorney generals and submit what they are setting out to do BEFORE they willy nilly just go ahead and do it?
Is it just me or does anybody else smell BIG money behind this attorney general BS ?
Every single one of these GIANT companies have a lobbyists' in D.C., this is no coincidence that these two dozen attorney generals all of a sudden joined hands in this attempt.......without somebody orchestrating this.
Stevie Wonder can see this.
Giant pharmaceutical, medical device companies etc. are well known for under the table illegal payola to doctors, politicians, you name it.
And many have been caught red-handed in this activity.
And I am quite sure the FDA is well aware of this fact, how could they not be ?
That's their business.
Bottom line, no crime has been committed......period !
Innocent.....UNTIL proven guilty.
This is STILL the United States of America...... at least for a little while longer.
Henceforth Any new drug approval will NOT even be considered for approval, without FIRST having a briefing with all attorney generals of the world.
There will be very stringent requirements to meet with approval by said attorney generals.
Any FDA official who does not abide by this requirement is opening themselves up to a horrific #$%$ whooping in the village square.
Will be stoned, tarred& feathered, just a general all around #$%$ kicking, and on top of that wil be kinda scorned and publicly humiliated.
IS THIS UNDERSTOOD........all you FDA peoples ?
We is the attorney generals, you mess with the attorney generals.....you get the horns !
Or something like that.
Proof ? What proof ? He don't know nothing about no steenking proof. He don't have to show you no steenking proof !
When drd369 says something, that's PROOF, no matter which name he uses at the time...So back off with the steenking proof requirement !
He da man, or wait a minute, many many man !
Faster than a speeding bullet.........drd369 makes yet another alias......TODAY !
Top part of my post was for some reason cut off.
I asked who broke any law, the FDA, Zogenix, Who ?
Every single one of these attorney generals need to be investigated.
of these attorney generals need to be investigated.
They getting kickbacks from someplace?
Nah......THAT would be totally unheard of.......nothing like that EVER happens.
Yeah right !
I never knew attorney generals followedThe FDA ? Zogenix ? Who ? Who the hell do any attorney generals think they are ? Who PUT these attorney generals up to this anyhow ?
Maybe EVERY single one FDA Approvals, all of a sudden all these attorney generals woke up one morning and said........what the hell's going on here, the FDA is approving some drug called Zohydro?
No wait a minute........what is that bell going off in my head, as an attorney general I better answer it.......Hello, the FDA just approved Zo what? A new pain killer ? Well we'll see about this, nobody ever consulted with ME about this !
Oh, there is a possible buck to be made here ? So who do I get in touch with ? Wait a minute I gotta get something to write with, no HOLD ON, wait a minute.
Now can you repeat that ?
drd369 Knows a lot of doctors and nurses, talks to them on a regular basis, and they all confide in drd369, they all go out together have something to eat ,a couple of mixed drinks, they ain't got nothing else to do but give drd369 the lowdown on all the hottest drugs, and all that good stuff.
They all even got him on speed dial to keep him updated on the latest, of whatever.
Man is this guy in fantasy land or what?
I'm thinking this guy dropped some bad LSD or something in the past.
"That "unknown" is the only thing fueling the shorts."
It's short, singular, with all the basher aliases here, and actually he's not even short, he's just an idiot with nothing else to do with his (drd369) time. If you look at the majority of his aliases here.......they coincidentally all originated within a few days, and some even on the same date. Most right around Dec12/13 of 2013. I'll post them tomorrow. With the dates they originated.
There is one of these mental midgets on every single message boards it seems like.
Even when the FDA does not pull Zohydro.......our village idiot will go on and on and on....
He has a severe case of OCD, and he's a pathological liar besides.
Now you're saying the crackheads won't even want Zohydro ?
I guess I'm gonna have to follow you and load up on that INVESTOR stock DNDN.
Because just like you with your "INVESTOR" stock DNDN..........we're ZGNX INVESTORS .
Unlike you we're looking farther than the ends of our noses.