Regulatory Exclusivity: NEW INDICATION
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Drugs with New Indication Regulatory Exclusivity
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Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Exclusivity Expiration | Patented / Exclusive Use |
---|---|---|---|---|---|---|---|---|---|---|---|
Exelixis Inc | CABOMETYX | cabozantinib s-malate | TABLET;ORAL | 208692-001 | Apr 25, 2016 | RX | Yes | No | See Plans and Pricing | TREATMENT OF PATIENTS WITH HEPATOCELLULAR CARCINOMA WHO HAVE BEEN PREVIOUSLY TREATED WITH SORAFENIB | |
Exelixis Inc | CABOMETYX | cabozantinib s-malate | TABLET;ORAL | 208692-002 | Apr 25, 2016 | RX | Yes | No | See Plans and Pricing | TREATMENT OF PATIENTS WITH HEPATOCELLULAR CARCINOMA WHO HAVE BEEN PREVIOUSLY TREATED WITH SORAFENIB | |
Exelixis Inc | CABOMETYX | cabozantinib s-malate | TABLET;ORAL | 208692-003 | Apr 25, 2016 | RX | Yes | Yes | See Plans and Pricing | TREATMENT OF PATIENTS WITH HEPATOCELLULAR CARCINOMA WHO HAVE BEEN PREVIOUSLY TREATED WITH SORAFENIB | |
Duchesnay | OSPHENA | ospemifene | TABLET;ORAL | 203505-001 | Feb 26, 2013 | RX | Yes | Yes | See Plans and Pricing | TREATMENT OF MODERATE TO SEVERE VAGINAL DRYNESS, A SYMPTOM OF VULVAR AND VAGINAL ATROPHY, DUE TO MENOPAUSE | |
Taiho Oncology | LONSURF | tipiracil hydrochloride; trifluridine | TABLET;ORAL | 207981-001 | Sep 22, 2015 | RX | Yes | No | See Plans and Pricing | TREATMENT OF ADULT PATIENTS WITH METASTATIC GASTRIC OR GASTROESOPHAGEAL JUNCTION ADENOCARCINOMA PREVIOUSLY TREATED WITH AT LEAST TWO PRIOR LINES OF CHEMOTHERAPY, AND IF APPROPRIATE, HER2/NEU-TARGETED THERAPY | |
Taiho Oncology | LONSURF | tipiracil hydrochloride; trifluridine | TABLET;ORAL | 207981-002 | Sep 22, 2015 | RX | Yes | Yes | See Plans and Pricing | TREATMENT OF ADULT PATIENTS WITH METASTATIC GASTRIC OR GASTROESOPHAGEAL JUNCTION ADENOCARCINOMA PREVIOUSLY TREATED WITH AT LEAST TWO PRIOR LINES OF CHEMOTHERAPY, AND IF APPROPRIATE, HER2/NEU-TARGETED THERAPY | |
Astrazeneca Ab | QTERN | dapagliflozin; saxagliptin hydrochloride | TABLET;ORAL | 209091-001 | Feb 27, 2017 | RX | Yes | Yes | See Plans and Pricing | EXPANDED INDICATION FOR USE AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS | |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Exclusivity Expiration | >Patented / Exclusive Use |