NDA 022406 describes XARELTO, which is a drug marketed by Janssen Pharms and is included in one NDA. It is available from two suppliers. There are five patents protecting this drug and one Paragraph IV challenge. Additional details are available on the XARELTO profile page.
The generic ingredient in XARELTO is rivaroxaban. There are thirty-four drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the rivaroxaban profile page.
NEW DOSING REGIMEN OF 10 MG ONCE DAILY FOR THE REDUCTION IN THE RISK OF RECURRENCE OF DEEP VEIN THROMBOSIS (DVT) AND/OR PULMONARY EMBOLISM (PE) IN PATIENTS AT CONTINUED RISK FOR DVT AND/OR PE AFTER COMPLETION OF INITIAL TREATMENT LASTING AT LEAST 6 MONTHS
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