Hydrogen Peroxide?????

[Anonymous]

Hydrogen Peroxide?????

 

[Anonymous]

Novel or EasySept?

 

[Anonymous]

OCD04 is approved for sale see.

http://www.accessdata.fda.gov/cdrh_docs/pdf11/K112909.pdf

So why is it not for sale? Your guess is as good as mine.

 

[Anonymous]

OCD04 is approved for sale see.

http://www.accessdata.fda.gov/cdrh_docs/pdf11/K112909.pdf

So why is it not for sale? Your guess is as good as mine.

Think of the millions of dollars being lost when an approved product is not marketed. Maybe B&L is gearing up the manufacturing for this product? A good management team would have had the production up and running as soon as the product was approved for sale.

 

[Anonymous]

Think of the millions of dollars being lost when an approved product is not marketed. Maybe B&L is gearing up the manufacturing for this product? A good management team would have had the production up and running as soon as the product was approved for sale.

It does seem strange to get a product approved and then not go ahead with the sale of the product? Maybe there is a stability problem, irritation problem or a legal issue?

Either way the FDA probably needs to be informed as they just issued the approval and would need to know if they made a mistake in approving the product.

 

[Anonymous]

???????????????????. What happened? Why the delay?

 

[Anonymous]

???????????????????. What happened? Why the delay?

If they have FDA approval for it when is the launch date??? Strange company.

 

[Anonymous]

FDA sent B&L a cease order. something about manufacturing it without approval. google it.

 

[Anonymous]

That was the Pilocarpine Hydrochloride product not the hydrogen peroxide.
search for "bausch" at
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/default.htm

makes for a fun read seeing B&ls non compliance with studies and drugs from the past.
dirty little company.

 

[Anonymous]

FDA sent B&L a cease order. something about manufacturing it without approval. google it.

B&L was forced to stop manufacturing hydrogen peroxide by the FDA?? Something must seriously be wrong with the product if this is the case. Does the FDA say what the problem is?? It is good that the FDA is looking out for the consumer and not letting bad products out the door.

 

[Anonymous]

B&L was forced to stop manufacturing hydrogen peroxide by the FDA?? Something must seriously be wrong with the product if this is the case. Does the FDA say what the problem is?? It is good that the FDA is looking out for the consumer and not letting bad products out the door.

FDA's warning letter:

http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2012/ucm310790.htm

 

[Anonymous]

off label promotion. what else is new with B&L. company has been misleading doctors, consumers and investors for decades. The culture persists even through multiple management turn overs.

when the company was public they cooked the books and got busted for that. 94-'97
http://johngarvey.files.wordpress.com/2010/01/bausch-lomb-case-study.pdf

then 10 years of off label promotion for Lotemax through 3 management teams which will ultimately concluded with an off label whistleblower case that was brought forward 2 years ago and will ultimately result in a settlement.

Management, culture, and reputation of the company are all pathetic. no future at this company.

 

[Anonymous]

Completely agree. FDA personnel are treated as brainless underachievers who cannot get a job in industry and only work for the FDA for some sort of power trip. Until B&L management starts to respect the agency, the house of cards will fall rapidly.