View Full Version : Interesting Article RE XR


wonderboy
07-19-17, 04:52 AM
http://www.capital-drug.com/prasco-acquires-tevas-authorized-generic-of-adderall-xr

If this was already well known, I apologize

sarahsweets
07-19-17, 06:45 AM
http://www.capital-drug.com/prasco-acquires-tevas-authorized-generic-of-adderall-xr

If this was already well known, I apologize

The article is from 2016. Does anyone know if its a done deal? I have yet to see any adderall around here from prasco. Even Teva/Barr. I get global which is still an Shire made product as far as the raw ingredients and formula.

wonderboy
07-19-17, 08:12 PM
I was reading on a different forum where a individual stated that Teva no longer manufactures -IR-

Is this correct? I believe the IR product is still on their webpage

https://www.tevagenerics.com/product/dextroamphetamine-saccharate-amphetamine-aspartate-dextroamphetamine-sulfate-and-amphetamine-sulfate-tablets-cii

namazu
07-19-17, 08:36 PM
Per the Drugs@FDA database (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=011522), Teva's generic Adderall (instant release) has been discontinued.

The same database does not yet reflect a shift from Teva to Prasco for generic Adderall XR, though Prasco already lists generic Adderall XR on their website. I don't know how long the paperwork and setup takes after the two companies agreed to the acquisition, or whether there have been other hiccups.

wonderboy
07-19-17, 09:36 PM
Per the Drugs@FDA database (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=011522), Teva's generic Adderall (instant release) has been discontinued.

The same database does not yet reflect a shift from Teva to Prasco for generic Adderall XR, though Prasco already lists generic Adderall XR on their website. I don't know how long the paperwork and setup takes after the two companies agreed to the acquisition, or whether there have been other hiccups.




It is just interesting that they still have it on their website as a product a pharmacist could order

wonderboy
07-19-17, 09:52 PM
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/011522Orig1s043ltr.pdf.


Teva's Women's Health ??

There is no doubt that their ANDA 040422 is discontinued. What to make of the above, however?

namazu
07-19-17, 10:00 PM
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/011522Orig1s043ltr.pdf
So this suggests that as of the date of this letter (January 2017), Teva was still on record as manufacturing short-acting Adderall. [?]
When I look up the application # referenced in the letter (011522), it still shows up as discontinued.
It looks like Teva's correspondence with FDA was dated October 2016. Unclear exactly when Teva decided to stop producing short-acting Adderall.
No idea how it ended up in Teva's Women's division!

wonderboy
07-19-17, 10:01 PM
So this suggests that as of the date of this letter (January 2017), Teva was still on record as manufacturing short-acting Adderall. [?]

So they applied in January 2017 ( and received a approval letter) and what you're telling me is they discontinued it since then? I'm not trying to give you the 3rd° at all, I am just confused

The letter is dated January 2017, not in 2016

namazu
07-19-17, 10:08 PM
So they applied in January 2017 ( and received a approval letter) and what you're telling me is they discontinued it since then? I'm not trying to give you the 3rd° at all, I am just confused
The letter is dated January 2017, not in 2016
I'm confused, too.

No, I think they applied in October 2016, and got this reply from FDA in January 2017.

However, it looks like the application was for a labeling change. They'd already been producing Adderall prior to that time.

If you go to the Drugs@FDA page for the product, near the bottom, there's an expanding section titled "Approval Date(s) and History, Letters, Labels, Reviews for NDA 011522" that gives the history of approvals and labeling changes.

wonderboy
07-20-17, 12:00 AM
But it appears that, "Teva's Women's Health" submitted an ANDA, and received approval.

I am going to personally contact Teva USA Generics and initiate some questioning...

NDA #011522 is interesting

When at the FDA site- search Teva amphetamine 2017

I'm confused, too.

No, I think they applied in October 2016, and got this reply from FDA in January 2017.

However, it looks like the application was for a labeling change. They'd already been producing Adderall prior to that time.

If you go to the Drugs@FDA page for the product, near the bottom, there's an expanding section titled "Approval Date(s) and History, Letters, Labels, Reviews for NDA 011522" that gives the history of approvals and labeling changes.

namazu
07-20-17, 12:21 AM
But it appears that, "Teva's Women's Health" submitted an ANDA, and received approval.

I am going to personally contact Teva USA Generics and initiate some questioning...
The letter you linked refers to an "sNDA" -- a supplementary submission (in this case, labeling change) for a previously-approved drug. All of the 30 updates on the Teva (Women's) generic Adderall page refer to supplementary submissions.

I did find a separate listing (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=040472) for generic Adderall IR made by TEVA Pharms (instead of the Women's division), under ANDA 040472. That's also listed as "discontinued".

If you call the company and get any useful information, please report back!

wonderboy
07-20-17, 04:09 PM
I spoke with a senior representative with Teva

She stated that although they were acquired by actavis, ( her statement) they are still manufacturing and selling to pharmacies Adderall IR generic Teva brand