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Old 05-29-2005, 03:31 AM   #1 (permalink)
Ian
 
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This just in... Able Laboratories, one of the manufacturers of generic Phentermine,
appears to be in some trouble regarding violations of manufacturing specifications or conditions:

Here's a link to the news article:

http://www.businessweek.com/ap/finan...=apn_home_down

Phentermine that was manufactured by Able Labs looks like this:



MAY. 19 3:58 P.M. ET Generic drug maker Able Laboratories Inc. said Thursday that an internal investigation found it violated certain laboratory testing norms, and therefore the company has decided to suspend all product shipments while it completes the review. Able Labs also said its chairman and CEO will resign and withdrew financial guidance.

The pharmaceutical firm's shares lost more than three quarters of their value after a trading halt was lifted by Nasdaq, plunging $18.36, or 74.5 percent, to $6.27 in recent activity. The stock had been trading between $17.60 and $26.49 over the past 52 weeks, and was up about 8 percent this year as of Wednesday's close.

Able recently recalled several products due to a variety of improper laboratory practices and deviation from standard operating procedures. The company notified the Food and Drug Administration of the problems and said in March that it would evaluate its practices in these areas.

The company added Thursday that it found issues that will lead it to recall additional products and decided to stop all shipments as a precaution. However, Able said it does not yet know the extent to which its methods violated established operating procedures or manufacturing practices.

About two hours after announcing the findings of the review, Able said Chairman and Chief Executive Dhananjay G. Wadekar will step down and be succeeded by Robert G. Mauro, its president and chief operating officer, on an interim basis. The company expects Wadekar to continue as a consultant.

Able said it does not know what actions the FDA may take in response to today's announcement.

"This disruption in shipment, even if temporary, is expected to have a material effect on the company's ability to meet its sales goals and operating objectives," Able Labs said in a statement explaining its withdrawal of all financial guidance.

The protocols being used in the review have been established by outside consultants, the company said.

In recent months, Able recalled a batch of the blood-pressure treatment atenolol because the pills were subpotent and would only stay stable for six months, along with various drugs used to combat the nausea that comes with chemotherapy because of impurity and stability failures, according to an FDA Web site. These were all "class II" recalls, meaning the product could temporarily hurt a patient's health but there was low risk of serious consequences.

In January, the company recalled a large group of metronidazole capsules for adult acne because they were mislabeled. That recall was considered a less serious, class III recall.

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Old 06-07-2005, 04:35 AM   #2 (permalink)
Squish T. Cat
 
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Huh.
Actually, I'm not surprised at all. In a chronic pain forum that I used to read once in a while, people who were taking the same generic medication said that meds made by Able were far inferior to the brand name or *any* other manufacturer that wasn't Able. In fact, they'd go to their pharmacist with their prescription and specifically tell him that if all he had were Able, then forget it, they'd go somewhere else.

And like I've mentioned before, the vast differences in two of the SAME meds from Able, both phentermine, make me really wonder what the heck is going on over there. Quality Control...she ain't what she used to be.

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Old 06-07-2005, 04:37 AM   #3 (permalink)
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I don't understand why these people just let their business go to ruins.
Do they not have the intellience to think about the consequences of
ripping people off?

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Old 06-07-2005, 04:53 AM   #4 (permalink)
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I doubt that many people who steal from others think about the consequences...or, if they do, they think that they'll never get caught and thus the consequences they consider are moot.

But with Able, I'm guessing the bottom line for them was, well...The Bottom Line in any corporation: The Stockholders (or the CEO, thank you Mr. Ken Lay.) The call of the Mighty Dollar let some high-ranking dirtbags demand from middle-management that they cut expenses at any cost, and the poor suckers got stuck with the "Cut $$ or join the unemployed" directive to cut costs. EVERYWHERE. This is just a theory, mind you, but I'm guessing that not only did the product suffer, but the employees of Able have also felt some pretty drastic cuts in benefits and pay, and I'll bet that employee morale was at an all-time low, even before the **** hit the fan. Just a guess.

But here's a clue to how I'm coming up with my theories: I work for Wal-Mart.

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Old 06-07-2005, 05:05 AM   #5 (permalink)
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I'm going to go ahead and assume your theory is true. It sounds very plausible.

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Old 06-07-2005, 05:01 PM   #6 (permalink)
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The generic Darvocet I used to take was made by Able, I recognize the imprint from their list.

This does not surprise me as I questioned it's efficacy many times. There were times I could take several of them and I might as well have been chewing Tic-Tacs, other times I would take one, and I would get so sick you would have thought I had taken too many and OD on them.

:P to Able!

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