FDA New Drug Application Number 21-319/S-001:
10-9-2002 Avodart ® (dutasteride) soft-gelatin capsules.
FDA New Drug Application Number 21-319: Approved 11-20-2001 for treatment of
benign prostatic hyperplasia (bph). Approvals in other markets are pending.
Chemical Formulae: C27H30F6N2O2. 528.53.
Dutasteride (also known as Avolve™, Avodart ® ™) is a new revolutionizing method for treating hair loss, benign prostatic
hyperplasia (BPH). Dutasteride is a recently approved drug developed by
GlaxoSmithKline.
The Oral (tablet form) Drug is approved both
the in the United States of America and in Europe, Dutasteride was approved on
the 9th of October, 2002: by the FDA (Food & Drug Administration) under the
trade name (Also known as Avolve™, Avodart ® ™) . In research by different
companies Dutasteride has shown dramatic success in restoring hair to bald men
in trials. Dutasteride works by interfering with 5-alpha-reductase enzymes that
break down the male hormone testosterone and turn it into dehydrotestosterone (DHT),
which causes hair to thin dramatically in later life.
Is Dutasteride safe?
Clinical trials of Dutasteride showed that it was generally well tolerated. Most
side effects were mild or moderate and generally went away while on treatment in
both the Dutasteride and placebo groups.
Drug-related side effects during the first six months were as follows:
The incidence of most drug-related sexual side
effects decreased with duration of treatment. The incidence of drug-related
breast tenderness and breast enlargement remained constant over the treatment
period. Ejaculate volume may be decreased in some patients with continued
treatment. This decrease did not appear to interfere with normal sexual function.
Dutasteride should not be used in women and children. Women who are pregnant or
may become pregnant should not handle this medicine because of possibility of
absorption and subsequent potential risk to a male foetus.
Men with liver disease should talk to their doctor before taking Dutasteride.
Men with an allergic reaction to Dutasteride or its ingredients should not take it.
Men treated with Dutasteride should not donate
blood until at least six months after their final dose to prevent the medicine
going to a pregnant woman through a blood transfusion.
How long does it take before Dutasteride work?
It may take up to 3 to 6 months for this medicine (Dutasteride) to work. Do not
stop taking this medicine without checking with your doctor. Be sure to keep all
laboratory and doctor appointments while you are taking this medicine.
Dutasteride is known as Avolve™ in the US, whilst in Europe it's known as
Avodart ® ™, this is very common for different medicines, it's mostly due to
different regulations in the US and Europe, both have been approved in Europe
and the US.
Dutasteride, Avolve™, Avodart ® ™ are all a product by GlaxoSmithKline.
