US approves generics of Abbott seizure drug

WASHINGTON (Reuters) - U.S. health regulators have approved several generic competitors to Abbott Laboratories' (ABT.N) delayed-acting, anti-seizure drug Depakote, officials said on Tuesday.

The U.S. Food and Drug Administration said cheaper copycat versions of the drug, known generically as divalproex sodium, will have to carry strong warnings about the risk of liver damage and birth defects just as the brand version, which is prescribed for epilepsy.

The drug is also approved to treat bipolar disorder and migraine headaches. Sales for Depakote were $1.5 billion in 2007, according to the company.

Teva Pharmaceutical Industries Ltd (TEVA.O) and Novartis AG's (NOVN.VX)(NVS.N) Sandoz unit are among those cleared by the agency to market generic versions.

Other approved manufacturers include Sun Pharmaceutical Industries Ltd.(SUN.BO), Dr. Reddy's Laboratories Ltd (REDY.BO) and Lupin Limited in India as well as Genpharm Inc and Nu-Pharm Inc in Canada. Minnesota-based Upsher-Smith Laboratories was also cleared.

Abbott also makes an extended-release version of Depakote and earlier this month settled litigation that allows Mylan Inc MYL.N to launch a generic for that version no later than Jan. 1.

Shares of Abbott closed down 27 cents to end the day's trade on the New York Stock Exchange at $55.94.

(Reporting by Susan Heavey; editing by Jeffrey Benkoe, Leslie Gevirtz)