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FDA Accepts sNDA for Higher Concentration Dose of Copaxone
Teva Announces FDA Acceptance of sNDA for a Higher Concentration Dose of COPAXONE® Given Three Times a Week
http://www.pharmalive.com/fda-accepts-snda-for-higher-concentration-dose-of-copaxone
Glatiramer acetate (also known as Copolymer 1, Cop-1, or Copaxone – as marketed by Teva Pharmaceuticals) is an immunomodulator drug currently used to treat multiple sclerosis. It is a random polymer of four amino acids found in myelin basic protein, namelyglutamic acid, lysine, alanine, and tyrosine, and may work as a decoy for the immune system. Glatiramer acetate is approved by the Food and Drug Administration (FDA) for reducing the frequency of relapses, but not for reducing the progression of disability. Observational studies, but not randomized controlled trials, suggest that it may reduce progression of disability.
Although the clinical definition of multiple sclerosis requires two or more episodes of symptoms and signs, glatiramer acetate is approved for treatment after single episodes. It is also used to treat relapsing-remitting multiple sclerosis. It is administered bysubcutaneous injection.
Inspection Management – How to Pass EU and FDA Inspections
Inspection Management – How to Pass EU and FDA Inspections
Gaseous Sterilization – New USP General Chapter
Gaseous Sterilization – New USP General Chapter <1229.7>
Generic Licensing News –NAPHAZOLINE NITRATE, featured product
NAPHOZALINE
PRODUCT USED AS
NAPHAZOLINE NITRATE
Naphazoline Nitrate is a rapid acting sympathomimetic vasoconstrictor of occular artierioles. It acts to decrease congestion of the conjunctiva and is found in many over-the-counter eye drops.
Naphazoline is primarily indicated in conditions like Corneal vascularity, Hyperaemia, Itching, Nasal congestion, and can also be given in adjunctive therapy as an alternative drug of choice in Sinusitis.
http://www.leadformix.com/ef1/preview_campaign.php?lf1=933470130c201312625317b456273
Click here to contact Farmak about this product.
more info
It is a sympathomimetic agent with marked alpha adrenergicactivity. It is a vasoconstrictor with a rapid action in reducing swelling when applied tomucous membrane. It acts on alpha-receptors in the arterioles of the conjunctiva to produce constriction, resulting in decreased congestion. It is an active ingredient in several over-the-counter formulations including Clear Eyes and Naphcon eye drops.
Naphazoline, 2-(1-naphthylmethyl)-2-imidazoline, is synthesized from (1-naphthyl)acetonitrile, which upon reaction with ethanol transforms into iminoester, and undergoes further heterocyclization into the desired imidazoline derivative upon reaction with ethylene diamine 
- A. Sonn, U.S. Patent 2,161,938 (1939).
DR ANTHONY MELVIN CRASTO
ORGANIC SPECTROSCOPY
New Drug Approvals 