ARTICLES IN THIS WEB SITE IS FOR YOUR REFERENCE ONLY. IF YOU HAVE ANY QUESTION, YOU SHOULD CONSULT WITH YOUR
DOCTOR IMMEDIATELY. ALL RIGHT RESERVED 2008. DO NOT COPY NOR TRANSFER ARTICLES TO OTHER WEBSITES NOR OTHER
FORMS OF PUBLICATIONS.
FDA Approves First Generic Divalproex Sodium
to Treat Seizures, Migraine Headaches and
Bipolar Disorder July 29, 2008
DRUG
INDUSTRY

Foundamental
Science
Colloidal Stabilization

Drug Product
Development
Patent Application
Product Development
Product Ingredients
Colorant
Scale up a batch 1
Drug Delivery Industry
Drug Delivery - Smart
Bomb
Lotion, Cream, Preps
Enteric Coating-Eudragit
Enteric Coating-Nutrateric
SR Coating-Aquacoat

Drug Industry
Drug Competitions
Drug in Development
Cholesterol-lowering
Drug-Terminologies
Packaging Materials

Market
Drug Dev- 2004
Drug Dev - 2005Q1
Drug Dev- 2005Q2
Drug Dev-2005Summer
Drug Dev-2005Q3
Orphan Drug
Protein Drug
Niche Market

Novo Norkdisk R&D

Equipment
Blenders

CONTRACT
MANUFACT.
Nutrition Supplements
The U.S. Food and Drug Administration today
approved the first generic versions of Depakote
delayed-release tablets (divalproex sodium).
Depakote is approved by the FDA for the treatment of
seizures, bipolar disorder and migraine headaches.

"Generic drugs undergo a rigorous scientific review to
ensure that they will provide the patient with the same
amount of high quality, safe and effective drug as the
name brand product," said Gary J. Buehler, director of
the FDA's Office of Generic Drugs. "This approval
provides an additional treatment option for patients
who suffer from epilepsy, bipolar disorder and
migraines."

Generic divalproex sodium will have the same safety
warnings as Depakote, including a Boxed Warning
that cautions about the risk of liver damage
(hepatotoxicity), including fatalities, and pancreatitis,
or an inflamed pancreas, including fatal cases. The
Boxed Warning also highlights the risk of birth defects
(teratogenicity), including neural tube defects.

The following firms have received approval to market
divalproex sodium delayed-release tablets: Sun
Pharmaceutical Industries Ltd., Mumbai, India;
Genpharm Inc., Ontario, Canada; Nu-Pharm Inc.,
Ontario, Canada; Upsher-Smith Laboratories, Maple
Grove, Minn.; Sandoz Inc., Broomfield, Colo.; TEVA
Pharmaceuticals USA, North Wales, Penn.; Dr. Reddy’
s Laboratories, Hyderabad, India; and Lupin Limited,
Mumbai, India.

SOURCE FDA Approves First Generic Divalproex
Sodium to Treat Seizures, Migraine Headaches and
Bipolar Disorder FDA NEWS July 29, 2008