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New drugs recently approved by the FDA.

New Medicines Discussion

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Pharmer.org will keep you updated on new drugs approved by the FDA. Since part of our purpose is pill identification, we are covering tablets and capsules only since these are identifiable. Feel free to add other types of new drug approvals that interest you.

And if you are prescribed any new medication and want to share your experience, please post in this forum.

First-Time Generics - December 2009

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First-Time Generic Approvals - December 2009

Tablets/Capsules Only
Generic
Drug Name
Generic
Manufacturer
Referenced
Brand Name
Approval
Date
DONEPEZIL HYDROCHLORIDE ORALLY DISINTEGRATING TABLETS, 5 MG AND 10 MG MUTUAL ARICEPT ODT, 5 MG AND 10 MG 12-11-09

Sources: US Food and Drug Administration and manufacturers' websites

New Oxycodone 30 mg??

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Hey Guys!

 

Someone that I know that takes Oxy 30's went to get his script filled today and the pharmacy gave him pills that were labeled M on one side and 771 on the other side.

When he asked the pharmacist what they were, she stated that they added a new ingredient in the pill that the drug dogs can sniff out.

Has anyone heard of such a thing. I looked all over and did not see anything about them.

Any help would be appreciated.

GoT

Apotex Generic OxyContin

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Apotex is the newest "generic" distributor added to Purdue's team of generic distributors.

 

HOW SUPPLIED

Oxycodone HCl Controlled-Release Tablets 10 mg are round, unscored, white-colored, convex tablets imprinted with OC on one side and 10 on the other.  They are supplied as follows:

NDC60505-3537-1:  child-resistant closure, opaque plastic bottles of 100

Oxycodone HCl Controlled-Release Tablets 20 mg are round, unscored, pink-colored, convex tablets imprinted with OC on one side and 20 on the other.  They are supplied as follows:

NDC60505-3538-1:  child-resistant closure, opaque plastic bottles of 100

Oxycodone HCl Controlled-Release Tablets 40 mg are round, unscored, yellow-colored, convex tablets imprinted with OC on one side and 40 on the other.  They are supplied as follows:

NDC60505-3539-1: child-resistant closure, opaque plastic bottles of 100

Oxycodone HCl Controlled-Release Tablets 80 mg are round, unscored, green-colored, convex tablets imprinted with OC on one side and 80 on the other.  They are supplied as follows:

NDC60505-3540-1: child-resistant closure, opaque plastic bottles of 100

New drug application for Hydromorphone (Exalgo) submitted to FDA

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I found this on Medwatch new drug applications.  Thought some of you might find it interesting...Ray
Exalgo (hydromorphone) Extended Release Tablets

Company: Covidien

Treatment for: Pain

Exalgo (hydromorphone) is an investigational once-a-day extended release opioid formulation for relief for of moderate to severe pain in opioid tolerant patients.

New Generic Oxycontin from Actavis - Oxycodone Controlled-Release Tablets

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There is now a new generic Oxycodone Controlled-Release from Actavis.

It was mentioned that they are very similar to the actual brand (Purdue Pharma), unlike the Mallinckrodt which were waxy like MS-Contin.

 

PRxO Generics

An Amerisourceergen Solution

 

From Actavis

Oxycodone CR 10mg Tablets - 100 - 52152-0408-02 - AB

Oxycodone CR 20mg Tablets - 100 - 52152-0409-02 - AB

Oxycodone CR 40mg Tablets - 100 - 52152-0410-02 - AB

Oxycodone CR 80mg Tablets - 100 - 52152-0411-02 - AB

*This product has limited availability and will be available while supplies last.

 

NanoGuardian.net

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Hi friends,

I was browsing through the a pharmaceutical journal back from 2008 and I came across an add for this technology. It was quite impressive, to say the least.

For all those interested, the webiste is as mentioned in the title- NanoGuardian.net.

 

First-Time Generics - November 2009

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First-Time Generic Approvals - November 2009

Tablets/Capsules Only
Generic
Drug Name
Generic
Manufacturer
Referenced
Brand Name
Approval
Date
Pill
Identification
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL TABLETS USP, 1 MG/0.005 MG BARR (Teva) FEMHRT TABLETS 11-06-09
LANSOPRAZOLE DELAYED-RELEASE CAPSULES USP, 15 MG AND 30 MG TEVA PREVACID DELAYED-RELEASE CAPSULES 11-10-09 15 mg - blue & flesh 93 7350; 30 mg - gray & flesh 93 7351
PERINDOPRIL ERBUMINE TABLETS, 2 MG, 4 MG AND 8 MG AUROBINDO ACEON TABLETS 11-10-09 2 mg - round white D 57; 4 mg - oblong white D 58; 8 mg - round white D 59
PERINDOPRIL ERBUMINE TABLETS, 2 MG, 4 MG AND 8 MG ROXANE ROXANE 11-10-09 2 mg - round white 54 551; 4 mg - round white 54 327; 8 mg - round white 54 715
LANSOPRAZOLE DELAYED-RELEASE CAPSULES USP, 15 MG AND 30 MG MATRIX (Mylan) PREVACID DELAYED-RELEASE CAPSULES 11-10-09 15 mg - green Mylan 8015; 30 mg - pink Mylan 8030
PERINDOPRIL ERBUMINE TABLETS, 2 MG, 4 MG AND 8 MG IVAX (Teva) ACEON TABLETS 11-10-09
TRAMADOL HYDROCHLORIDE ER TABLETS, 100 MG AND 200 MG PAR ULTRAM ER TABLETS, 100 MG AND 200 MG 11-13-09 100 mg - round white Par 821; 200 mg - round white Par 822

Sources: US Food and Drug Administration and manufacturers' websites

First-Time Generics - October 2009

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First-Time Generic Approvals - October 2009

Tablets/Capsules Only
Generic
Drug Name
Generic
Manufacturer
Referenced
Brand Name
Approval
Date
Pill
Identification
BUPRENORPHINE HYDROCHLORIDE SUBLINGUAL TABLETS, 2 MG (BASE) AND 8 MG (BASE) ROXANE SUBUTEX SUBLINGUAL TABLETS 10-08-09 2 mg - round white 54 775; 8 mg - round white 54 411
See Karbine-Kyle's image of 54 411
CHENODIOL TABLETS, 250 MG NEXGEN CHENIX TABLETS, 250 MG 10-22-09 Round white MP 250

Sources: US Food and Drug Administration and manufacturers' websites

Just Switched from Suboxone® to Generic Subutex®

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Hello Everybody!

I just switched from Suboxone® to Generic Subutex®. I was just posting this so I could help others or if anyone else had any information about the Generic. They are made by Roxane Laboratories™. They come in 2mg and 8mg strengths. I use to take Methadose® (Methadone) 40mg dispersable tablets 2-4x daily, and before that, every opioid that I could get, for back pain. My parents detoxed me off of Methadone, and took me to a walk-in clinic, whose doctor also does detox. After going through H*** of withdrawals from the Methadone, I was given a shot of Buprenex® at the doctor's office. He then dispensed 4 Subutex® tablets for the first couple of days, and then a couple days later, he put me on Suboxone®. It really helped me, not just for addiction or pain, but I also feel that it has helped my depression. The only problem is the cost. I have been clean for almost 2 years now, but I don't have insurance. My parents had to pay for most of the visits once a month and the Suboxone®. When the generic formulation of Subutex® (Buprenorphine) came out, my doctor did not want to switch me, so I wrote him a letter, telling him how expensive the Suboxone® was, and how much money we were losing, and how it was effecting us financially. I begged him to put me on the generic Subutex®, which I will now just call "Buprenorphine". He was very hesitant, but he went through for me. I take 4mg 2x daily (8mg Buprenorphine), in the morning, and the evening. I also take 2mg of Klonopin® (Clonazepam) 3x daily, because I have ungodly panic disorder. Honestly, I feel fine. The only difference is, is the tablets are a little "harder", when I mean "harder", I mean how much the tablets have been pressed. They aren't as soft as the generics, but they do dissolve just as fast, in my opinion. I really don't see any difference between the Suboxone®, and the Buprenorphine. They are about the same size as the Suboxone® sublingual tablets, but they are white, flat, round sublingual tablets, with one side saying "54 411" and the other side is blank, no scores, nothing. They are bitter, just like the brand name, but they are just as effective as the generic so far. This is my 5th day taking the Buprenorphine. It doesn't contain Naloxone like the Suboxone®, and they honestly are a lot cheaper, by about ½ the price. A Qty. #30 Buprenorphine sublingual tablets are ~$112, still, pretty pricy, but the brand Subutex® Qty. #30 sublingual tablets are ~$220. That's a approximately $100 cheaper. I live in Florida, so the costs may be different, depending on where you live, or what pharmacy. I use Walgreens®. I do have a discount card, but it only saved me about $10. I find them just as effective as the brand name Buprenorphine sublingual tablets, W or W/O Naloxone (Antagonist/Blocker). They do help my back pain just a little, but to be honest, I'm in a much better mood, and I'm more "lively". My depression has dropped dramatically, which I found strange. Harvard Medical Studies shows that Buprenorphine might have antidepressant potentials. Check that out on Wikipedia, and type "Buprenorphine." Don't take it for depression, that's not what it's for, (except in my case). It has really helped! Since there isn't a generic for Suboxone® yet, try asking your doctor to switch you to the generic Subutex® if you want to, or have to, like I did. I did submit a picture here on what the tablets look like and what the bottle looks like (for the 8mg tablets) by Roxane Laboratories™. It can be found in the "Contrib" section. I'm just posting this to let you know there is a generic for Subutex®. The cost is about ½ that of the brand. I just wanted to let you all know. I am NOT a doctor, so don't attempt, or take anything without talking to your doctor first. This is just information on the effectiveness of the generic VS the brand Subutex® or Suboxone®. I hope all of you who may be in my position will get help! Talk to your doctor, and tell him/her the truth about your situation! I hope and pray for all of you, and I hope that you will all have a Merry Christmas & a Happy New Year!

- "Karbine" Kyle

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