Shire (SHPGY) and New River Pharmaceuticals (NRPH) saw their shares jump Monday after regulators said their attention-deficit hyperactivity disorder drug was approvable.
Shares of Shire were up 8.7% to $53.70, while New River's shares soared to $38.53, up 47%.
The Food and Drug Administration says the drug is approvable but is contingent on a schedule determination by the U.S. Drug Enforcement Administration, Shire said in a press release late Friday. No additional trials need to be conducted for the drug to be cleared.
The FDA has requested that the drug be assigned the status of a schedule II controlled substance, indicating that the treatment has a high potential for abuse and should be prescribed with certain restrictions.
The two companies and the FDA are still discussing a trade name for the drug, which is currently dubbed NRP104. The drug is on track to go on sale in the first quarter of 2007.
Shares of Shire were up 8.7% to $53.70, while New River's shares soared to $38.53, up 47%.
The Food and Drug Administration says the drug is approvable but is contingent on a schedule determination by the U.S. Drug Enforcement Administration, Shire said in a press release late Friday. No additional trials need to be conducted for the drug to be cleared.
The FDA has requested that the drug be assigned the status of a schedule II controlled substance, indicating that the treatment has a high potential for abuse and should be prescribed with certain restrictions.
The two companies and the FDA are still discussing a trade name for the drug, which is currently dubbed NRP104. The drug is on track to go on sale in the first quarter of 2007.
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