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Dr. Bob is Robert Hsiung, MD,
bob@dr-bob.orgShown: posts 1 to 9 of 9. This is the beginning of the thread.
Posted by Phillipa on December 13, 2013, at 20:53:30
6 companies have been granted approval to market generic Cymbalta. Phillipa
FDA Approvals > Medscape Medical NewsFDA Okays First Cymbalta Generics
Caroline Cassels
DisclosuresDecember 11, 2013
The US Food and Drug Administration (FDA) has approved the first generic versions of the antidepressant duloxetine, delayed-release capsules (Cymbalta, Eli Lilly and Company).
Six pharmaceutical companies including Aurobindo Pharma Ltd, Dr. Reddy's Laboratories Ltd, Lupin Ltd, Sun Pharma Global FZE, Teva Pharmaceuticals USA, and Torrent Pharmaceuticals Ltd have received FDA approval to market duloxetine in various strengths.
Information from Industry
"Health care professionals and consumers can be assured that these FDA-approved generic drugs have met our rigorous standards," said Kathleen Uhl, MD, acting director of the Office of Generic Drugs in the FDA's Center for Drug Evaluation and Research. "Generic drugs offer greater access to health care for many people."
Duloxetine and other antidepressant drugs have a boxed warning describing the increased risk for suicidal ideation and behavior during initial treatment in children, adolescents, and young adults aged 18 to 24 years, but this risk is decreased in those aged over 24 years.
According to the FDA, approved generics have equivalent efficacy to brand-name drugs. Generic prescription drug manufacturing and packaging sites must pass the same quality standards as those of brand-name drugs, the agency notes.
Posted by ed_uk2010 on December 14, 2013, at 1:36:54
In reply to Cymbalta Goes Generic, posted by Phillipa on December 13, 2013, at 20:53:30
>6 companies have been granted approval to market generic Cymbalta.
Read this yesterday. Seems specific to the US. We only have branded Cymbalta here, although there have been frequent supply issues in the UK. Perhaps when the generics are launched, pts will actually be able to get their prescription filled!
Posted by Phillipa on December 14, 2013, at 19:02:33
In reply to Re: Cymbalta Goes Generic » Phillipa, posted by ed_uk2010 on December 14, 2013, at 1:36:54
Ed interesting that here and not there as seemed that UK usually had a generic before the USA. Do you have the same patents. I know the original Cymbalta is manufactured by one company. But why not generics now in UK? Do the generics need to be tested more thoroughly that they are here in US? PJ
Posted by ed_uk2010 on December 15, 2013, at 10:20:10
In reply to Re: Cymbalta Goes Generic » ed_uk2010, posted by Phillipa on December 14, 2013, at 19:02:33
>Ed interesting that here and not there as seemed that UK usually had a generic before the USA. Do you have the same patents. I know the original Cymbalta is manufactured by one company. But why not generics now in UK? Do the generics need to be tested more thoroughly that they are here in US?
The patent laws appear to be somewhat different across the world. Approval is also by different agencies.
Posted by linkadge on December 18, 2013, at 19:16:57
In reply to Re: Cymbalta Goes Generic, posted by ed_uk2010 on December 15, 2013, at 10:20:10
I think its been generic here in Canada for a few years now.
Linkadge
Posted by Phillipa on December 18, 2013, at 22:24:55
In reply to Re: Cymbalta Goes Generic, posted by linkadge on December 18, 2013, at 19:16:57
Really? I wonder why? Phillipa
Posted by ed_uk2010 on December 20, 2013, at 15:23:48
In reply to Re: Cymbalta Goes Generic » linkadge, posted by Phillipa on December 18, 2013, at 22:24:55
> Really? I wonder why? Phillipa
I believe patent regulations vary between countries.
Posted by Phillipa on December 20, 2013, at 20:43:14
In reply to Re: Cymbalta Goes Generic » Phillipa, posted by ed_uk2010 on December 20, 2013, at 15:23:48
Ed I didn't know this. Is it more prescribed now since generic? PJ
Posted by ed_uk2010 on December 21, 2013, at 11:59:09
In reply to Re: Cymbalta Goes Generic » ed_uk2010, posted by Phillipa on December 20, 2013, at 20:43:14
Hi PJ,
>Ed I didn't know this. Is it more prescribed now since generic?
Cymbalta is not frequently used here, and there is no generic yet, so I'm not sure. It never really caught on... amitriptyline, gabapentin and pregabalin are used for chronic neuropathic pain and other drugs for depression (in which case its effectiveness is apparently not better than other ADs). I expect it will be used more frequently for chronic pain in the future, but maybe not for depression.
This is the end of the thread.
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