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[IP] Novo Nordisk's Novolog - FDA Approval
It is my understanding Novolog is the equivalent of
Humalog. When I spoke to my new endo about mixing
small amounts of Novolin's Velosulin BR with Humalog.
He said mixing was fine with him if it worked, but too
bad Lilly stopped making their buffered regular
insulin because it is better to mix like brands which
contain the same receptors. This may be possible in a
few months since the FDA has approved Novolog (see
article below). Does anyone know how long it typically
takes to get a new drug on the shelf following FDA
approval? The price of Humalog may even go down?
I am going to call Novo Nordisk tomorrow to get more
info (800-727-6500 8am-8pm EST).
Who after two years of searching
has finally found an endo she likes :]
PS. I want to thank everyone who answered my questions
on "Mixing Small Amounts of Velosulin BR/Humalog"
especially Michael, Connie, Kerry, Andrew and Ruth.
Your support and the time it took for you to write
those posts are greatly appreciated!
FDA Approves Novo Nordisk's Novolog Insulin
WASHINGTON, Jun 09 (Reuters Health) - Novo Nordisk,
Princeton, New Jersey, received approval on June 7
from the US Food and Drug Administration (FDA) for
NovoLog insulin aspart (rDNA origin) injection for the
control of hyperglycemia in adult patients with
Novolog has faster absorption, is faster acting and
has a shorter duration of action than regular human
insulin. Because the drug lowers blood sugar levels
quickly, patients can inject themselves immediately
before eating, rather than 30 minutes before, as
regular insulin requires.
The drug will be available in vial, Penfill and
prefilled syringe for subcutaneous injection. Novolog,
for which a launch date has not been set, will enter a
US market of approximately $500 million, which
represents the niche for "short-acting" or insulin
analogues, out of a total US market of about $950
million for all insulins, Susan Jackson, Novo Nordisk
director of corporate communications, told Reuters
The global market for all insulin products is about
$2.4 billion, of which about 20% to 25% represents
insulin analogues, Jackson said. She added that Novo
Nordisk is wrapping up clinical studies for a
pediatric indication for Novolog and will file a
supplement with the FDA shortly.
Novolog, the latest addition to the firm's portfolio
of insulin products including DNA recombinants Novolin
and Velosulin human insulin injections, is the first
of several insulin analogues under development by the
Other Novo Nordisk products in the pipeline include
premixed and long-acting insulin analogues. NovoLog
was cleared for adult and pediatric patients in the
European Union last year, where it is marketed in
countries including the United Kingdom and Germany as
Novo Nordisk Pharmaceuticals, Inc. is the US affiliate
of Novo Nordisk A/S, based in Copenhagen, Denmark. The
company's shares closed down 2-5/16 at 81-11/16 on the
New York Stock Exchange on Thursday.
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