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Last Updated: October 26, 2020

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Regulatory Exclusivity: MISCELLANEOUS

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Drugs with Miscellaneous Regulatory Exclusivity

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Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Exclusivity Expiration Patented / Exclusive Use
Astellas LEXISCAN regadenoson SOLUTION;INTRAVENOUS 022161-001 Apr 10, 2008 RX Yes Yes   Start Trial INFORMATION ADDED TO THE LABELING REGARDING USE OF REGADENOSON ADMINISTRATION FOLLOWING AN INADEQUATE EXERCISE STRESS TEST AS COMPARED TO REGADENOSON ALONE
Sunovion Pharms Inc LATUDA lurasidone hydrochloride TABLET;ORAL 200603-003 Dec 7, 2011 AB RX Yes No   Start Trial REVISIONS TO THE PEDIATRIC USE SECTION OF THE LABELING REFLECTING LACK OF EFFICACY FOR IRRITABILITY ASSOCIATED WITH AUTISTIC DISORDER IN PEDIATRIC PATIENTS AGES 6-17
Sunovion Pharms Inc LATUDA lurasidone hydrochloride TABLET;ORAL 200603-005 Jul 12, 2013 AB RX Yes No   Start Trial REVISIONS TO THE PEDIATRIC USE SECTION OF THE LABELING REFLECTING LACK OF EFFICACY FOR IRRITABILITY ASSOCIATED WITH AUTISTIC DISORDER IN PEDIATRIC PATIENTS AGES 6-17
Sunovion Pharms Inc LATUDA lurasidone hydrochloride TABLET;ORAL 200603-001 Oct 28, 2010 AB RX Yes Yes   Start Trial REVISIONS TO THE PEDIATRIC USE SECTION OF THE LABELING REFLECTING LACK OF EFFICACY FOR IRRITABILITY ASSOCIATED WITH AUTISTIC DISORDER IN PEDIATRIC PATIENTS AGES 6-17
Mallinckrodt Hosp OFIRMEV acetaminophen SOLUTION;INTRAVENOUS 022450-001 Nov 2, 2010 AP RX Yes Yes   Start Trial REVISIONS TO THE PACKAGE INSERT BASED ON DATA FROM A RANDOMIZED, PLACEBO CONTROLLED, MULTICENTER STUDY OF INTRAVENOUS ACETAMINOPHEN FOR THE TREATMENT OF ACUTE PAIN IN PEDIATRIC PATIENTS TO FULFILL THE POST-MARKETING REQUIREMENT 1704-1
Janssen Pharms INVOKAMET canagliflozin; metformin hydrochloride TABLET;ORAL 204353-004 Aug 8, 2014 RX Yes Yes   Start Trial NEW CLINICAL DATA ADDED TO THE PRESCRIBING INFORMATION REGARDING CANAGLIFLOZIN ADD-ON COMBINATION THERAPY WITH METFORMIN AND A DIPEPTIDYL-PEPTIDASE-4 INHIBITOR
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Exclusivity Expiration >Patented / Exclusive Use

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Serving leading biopharmaceutical companies globally:

Dow
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Boehringer Ingelheim
Merck
Mallinckrodt
Express Scripts

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