Approval??

Was Abilify Depot approved today??

 

Not that anyone has heard yet? Seems kind of strange that the 26th was the target date and not a peep today?

 

They usually announce it in the morning. If you do some digging on FDA website you may be able to find it. Im sure you have nothing to worry about

 

Nothing on FDA website, however it is just an injectable form of an older molecule so I am sure it is not a top priority!

 

NOT APPROVED!

Otsuka receives complete response letter for extended-release injectable suspension of aripiprazole
H. Lundbeck A/S (Lundbeck) and Otsuka Pharmaceutical Co., Ltd. (Otsuka) today announced receipt of a complete response letter (CRL) from the U.S. Food and Drug Administration (FDA) to the New Drug Application (NDA) for the investigational intramuscular (IM) depot formulation of aripiprazole. In the letter, the only issue FDA cited was deficiencies from a recent inspection of a third-party supplier of sterile water.

Otsuka is working closely with the third-party supplier to resolve the issue as quickly as possible and is planning further discussions with the agency to determine next steps.

 

Re: NOT APPROVED!

Any idea how long it takes to fix a deficiency in sterile water....if you were offered a position, have you been contacted about new timeline?

 

Re: NOT APPROVED!

virtually not even a issue can be resolved within days. Could have been a issue as small as something you would see in a dirty kitchen at a restaurant and can be corrected as soon as it is pointed out.

 

paperwork must be refiled with FDA, can take a few weeks to correct and for approval.

 

The drug did not get approval. Something to do with the sterile water that is used to mix it. I don't know what next step is with FDA.

 

Will there be changes to the hiring timeline based on the news?

 

Probably not much Maybe a few weeks or months. I would think it would go ahead as planned that way you are all trained etc when the approval happens. Seems like it is not that big of a deal. Usually the big deals are where you have to go back and redo trials etc.

 

Wonder if this will affect some people who haven't officially accepted at this time. Maybe some will feel precarious about going to training without approval? Or maybe not. Seems like a great opportunity!

 

Has anyone heard from managment or anyone at the company? I just thought we may have heard from someone by now.

 

Yes, they are still working with FDA to see what steps need to happen in order to resolve issue as soon as possible. Doesn't look as though it will be a major setback.It has nothing to do with the efficacy,safety, or data. The manufacture site was the problem. They are supposed to know by early next week what or how long of a delay it may be for hire. As of today, they are going forward as planned and still looking at October launch meeting. Otsuka sales force already hired and heading to training. May only be a week or 2 difference in hire date. Keep faith!

 

This was a major concern of mine during the interviews, and I never got an answer that satisfied me. I've been part of several drug launches and I've yet to see a drug get final FDA approval on it's first submission. They always want more info on this, or get a few more results on that. There's no way this takes a few days. A few months at the soonest. The FDA works sloooooooowww.....what would you expect, it's part of the federal government?

I guess Otsuka can always have their new sales force promote their current drugs. In the mean time, I'm curious what Lundbeck does. Tell everyone to just hang on until final approval? Go ahead and bring them on with absolutely nothing to sell and keep your fingers crossed that this thing gets final approval in the next month or two? I think it's the latter option, seeing as how the offers were "conditional" until final approval. They better hope the FDA works fast, or they'll be re-running this rodeo all over again.

 

got the call tonight....the offer was made to someone else...bummer...oh well at least i know now and don't have to wait for the email.

 

If Otsuka wants them to bring everyone on Lundbeck will. They are basically calling the shots right now. Problem is what will you do. Sell Lundbecks drugs for the short term? Doubt it
I have been in this situation before with another company but there were other drugs to sell.
This is the chance you take interviewing for a jOb where the drug hasn't been approved yet.

 

Im sorry. Where u from? Southeast northeast midwest west coast?

 

Has anybody recieved an offer/rejection notice from their interview in Chicago week of 7/23?

 

Yes- Rejected.