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Roxanol being pulled from the market by FDA



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No. 10
from doodlemom
Old Apr 04, 2009, 12:51 PM

Default Re: Roxanol being pulled from the market by FDA
I take that back...it doesn't list oxyfast in the approved or unapproved column
List of Approved Narcotics Drug Products:

Morphine Sulfate Tablets and Solutions

Drug NDC #* NDA# Manufacturer Morphine Sulfate Tablets 15 & 30 mg 00054 22207 Roxane Morphine Sulfate Oral Solutions
10mg/5 ml &
20mg/5ml 00054
00054 22195 Roxane Morphine Sulfate Extended Release Tablets 00406 76412 Mallinckrodt Morphine Sulfate Tablets Extended Release 60951 75295 Endo/Skyepharma Hydromorphone Immediate Release Tablets

Drug NDC #* NDA# Manufacturer Hydromorphone immediate release tablets – 2, 4, AND 8 mg 00074
00406 19892
78273 Abbott
Mallinckrodt Oxycodone

Drug NDC #* NDA# Manufacturer Oxycodone immediate release tablets – 5, 10, 15, and 30 mg 00406 76758 Mallinckrodt Oxycodone immediate release tablets, 5, 15, and 30 mg 00254 77-712 Vintage Oxycodone Extended Release Tablets, 10 mg 59011 20-553
75923 Purdue
Endo Oxycodone Extended Release Tablets, 15 mg 59011 20553 Purdue Oxycodone Extended Release Tablets, 20 and 40 mg 59011 20553 Purdue * 5-digit Labeler Code of the NDC number

List of Unapproved Narcotics Drug Products Subject to Warning Letters

Firms Products Mallinckrodt Inc. Pharmaceuticals Group Morphine Sulfate Concentrate Oral Solution 20mg/ml Boehringer Ingelheim Roxane Inc. Roxanol Oral Solution, 20 mg/ml;
Roxicodone Tablets, 5 mg Roxane Laboratories, Inc. Hydromorphone Hydrochloride Tablets, 2 mg & 4 mg Glenmark Generics Inc.
Morphine Sulfate Tablets, 15 mg & 30 mg;
Morphine Sulfate Solution Immediate Release Concentrate, 20 mg/ml;
Morphine Sulfate Solution Immediate Release Oral Solution, 20mg/5ml Lannett Company, Inc. Morphine Sulfate Solution Immediate Release 20mg/ml;
Hydromorphone HCl Tablets, 2mg and 4mg Lehigh Valley Technologies Inc. Morphine Sulfate Tablets, 15 mg & 30 mg;
Morphine Sulfate Solution Concentrate, 20 mg/ml Physicians Total Care, Inc. Morphine Sulfate Immediate Release Tablets, 30 mg;
Hydromorphone Tablets, 2 mg;
Hydromorphone Hydrochloride Tablets 4 mg Xanodyne Pharmaceuticals Inc. Roxanol Oral Solution, 20 mg/ml;
Roxicodone Tablets, 5 mg Cody Laboratories, Inc. Morphine Sulfate Solution Immediate Release 20mg/ml * 5-digit Labeler Code of the NDC number
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No. 11
from rngolfer53
Old Apr 04, 2009, 02:07 PM
Updated Apr 04, 2009 at 02:12 PM by rngolfer53

Default Re: Roxanol being pulled from the market by FDA
Originally Posted by heron View Post
Even if it turns out that no-one manufactures 20:1 morphine concentrate, the solution is simple ... take the ordered dosage in morphine IR pill, crush and suspend in 1/2 - 1 cc of hot water. What's the emergency?
Not sure that families in the home, where many Pts prefer to remain, are going to love this idea.

And I still can't help but wonder why the FDA suddenly has this twist in their shorts. Call me cynical, but it rather sounds like some bureaucratic power trip.
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No. 12
from Melinurse
Old Apr 04, 2009, 06:06 PM

Default Re: Roxanol being pulled from the market by FDA
So why exactly is it being pulled? Is it just because someone forgot to go through the FDA red-tape? We have had no problems getting our Roxinal filled or even heard of any kind of ban/re-call. We occasionally do use oxyfast though and no problems there either in ordering. rngolfer53, I agree, sounds like bureucratic bologna to me too.
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No. 13
from heron
Old Apr 04, 2009, 06:39 PM

Default Re: Roxanol being pulled from the market by FDA
Originally Posted by doodlemom View Post
MSIR and oxyfast are being pulled, as well.

From my reading, not all brands, just those that don't comply. The only one that has no approved version is the 20:1 morphine concentrate, according to the linked article.
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No. 14
Old Apr 06, 2009, 05:14 PM

Default Re: Roxanol being pulled from the market by FDA
Why's this arising now?

And how did these meds get the original go-ahead without full approval?
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No. 15
Old Sep 25, 2009, 01:31 PM

Default Re: Roxanol being pulled from the market by FDA
As a FYI from someone in the drug industry. The drugs were allowed on the market for a while due to being "grandfathered" in. This means for drugs that had been manufactured prior to a certain date, they were allowed to be sold since they had already been in the market for a while. You may not have noticed since the FDA was very quiet about it, but they rescinded the warning letters and have allowed some of the manufacturers to remain on market. I know that a number of companies had already filed with the agency and had been waiting for approval when the warning letters came out.
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