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 |
---|---|---|---|---|---|---|---|---|---|---|---|
Pharmacyclics Inc | IMBRUVICA | ibrutinib | CAPSULE;ORAL | 205552-002 | Dec 20, 2017 | RX | Yes | No | See Plans and Pricing | INFORMATION ADDED TO THE PRESCRIBING INFORMATION TO INCLUDE EFFICACY AND SAFETY DATA FROM A STUDY IN PATIENTS WITH TREATMENT NAIVE CLL/SLL TREATED WITH IBRUTINIB IN COMBINATION WITH OBINUTUZUMAB OR CHLORAMBUCIL IN COMBINATION WITH OBINUTUZUMAB | |
Pharmacyclics Inc | IMBRUVICA | ibrutinib | CAPSULE;ORAL | 205552-001 | Nov 13, 2013 | RX | Yes | Yes | See Plans and Pricing | INFORMATION ADDED TO THE PRESCRIBING INFORMATION TO INCLUDE EFFICACY AND SAFETY DATA FROM A STUDY IN PATIENTS WITH TREATMENT NAIVE CLL/SLL TREATED WITH IBRUTINIB IN COMBINATION WITH OBINUTUZUMAB OR CHLORAMBUCIL IN COMBINATION WITH OBINUTUZUMAB | |
Pharmacyclics Inc | IMBRUVICA | ibrutinib | TABLET;ORAL | 210563-001 | Feb 16, 2018 | RX | Yes | No | See Plans and Pricing | INFORMATION ADDED TO THE PRESCRIBING INFORMATION TO INCLUDE EFFICACY AND SAFETY DATA FROM A STUDY IN PATIENTS WITH TREATMENT NAIVE CLL/SLL TREATED WITH IBRUTINIB IN COMBINATION WITH OBINUTUZUMAB OR CHLORAMBUCIL IN COMBINATION WITH OBINUTUZUMAB | |
Pharmacyclics Inc | IMBRUVICA | ibrutinib | TABLET;ORAL | 210563-002 | Feb 16, 2018 | RX | Yes | No | See Plans and Pricing | INFORMATION ADDED TO THE PRESCRIBING INFORMATION TO INCLUDE EFFICACY AND SAFETY DATA FROM A STUDY IN PATIENTS WITH TREATMENT NAIVE CLL/SLL TREATED WITH IBRUTINIB IN COMBINATION WITH OBINUTUZUMAB OR CHLORAMBUCIL IN COMBINATION WITH OBINUTUZUMAB | |
Pharmacyclics Inc | IMBRUVICA | ibrutinib | TABLET;ORAL | 210563-003 | Feb 16, 2018 | RX | Yes | No | See Plans and Pricing | INFORMATION ADDED TO THE PRESCRIBING INFORMATION TO INCLUDE EFFICACY AND SAFETY DATA FROM A STUDY IN PATIENTS WITH TREATMENT NAIVE CLL/SLL TREATED WITH IBRUTINIB IN COMBINATION WITH OBINUTUZUMAB OR CHLORAMBUCIL IN COMBINATION WITH OBINUTUZUMAB | |
Pharmacyclics Inc | IMBRUVICA | ibrutinib | TABLET;ORAL | 210563-004 | Feb 16, 2018 | RX | Yes | Yes | See Plans and Pricing | INFORMATION ADDED TO THE PRESCRIBING INFORMATION TO INCLUDE EFFICACY AND SAFETY DATA FROM A STUDY IN PATIENTS WITH TREATMENT NAIVE CLL/SLL TREATED WITH IBRUTINIB IN COMBINATION WITH OBINUTUZUMAB OR CHLORAMBUCIL IN COMBINATION WITH OBINUTUZUMAB | |
Astrazeneca Ab | BYDUREON | exenatide synthetic | FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS | 022200-001 | Jan 27, 2012 | DISCN | Yes | No | See Plans and Pricing | INFORMATION ADDED TO LABELING REGARDING A RANDOMIZED, PLACEBO-CONTROLLED CLINICAL TRIAL TO EVALUATE CARDIOVASCULAR OUTCOMES AFTER TREATMENT WITH EXENATIDE ONCE WEEKLY IN PATIENTS WITH TYPE 2 DIABETES MELLITES | |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Exclusivity Expiration | >Patented / Exclusive Use |