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 Dr. Lee is the founder and owner of Regrowth LLC, a company based in Los Angeles and dedicated to the treatment of hair loss. He has been developing innovative products and treating hair loss sufferers for the past 16 years. Dr. Lee is the creator of the Xandrox line of hair loss treatments.
Important Note: Due a busy schedule, Dr. Lee cannot answer any new questions at this time; however, he will be providing high quality answers to questions he receives from his own practice exclusively to Morphollica.com regularly
anonymous
2005-05-15
TEVA Pharmaceuticals pending FDA-approval for Finasteride
Dr. Lee, I was browsing the
FDA's web site and came across FDA Application No. (ANDA) 076511 for generic
finasteride, by TEVA Pharmaceuticals. The Action Date is 10/26/2004 and the
Approval Type is listed as "Tentative Approval." Have you heard of this
before?
You're a good detective. Sure enough the FDA shows this listing at http://www.fda.gov/cder/ogd/approvals/ta1004.htm: 76-511 FINASTERIDE TABLETS, USP 5 MG TEVA PHARMACEUTICALS USA
10/26/2004 However, in another section of the FDA website: Section of the FDA website you will find that the patent expiration for Proscar is 19 June 2006. So, what it all means is that Teva Pharmaceuticals has been approved by the US
FDA to market a 5mg finasteride tablet, but it can't be on the market until on
or after 19 June 2006. If you access the Teva Pharmaceutical website, you
will not find any references to finasteride. Richard Lee, M.D.
Regrowth, LLC,
www.Minoxidil.com
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