Company |
Product |
Description |
Indication |
Status |
Allergan plc, of Dublin |
Botox (onabotulinumtoxinA) |
Acetylcholine receptor antagonist; p130Cas associated protein inhibitor |
Pediatric upper and lower limb spasticity |
FDA accepted sBLAs, designating priority review for upper limb spasticity indication with PDUFA date expected in second quarter, and standard review for lower limb spasticity with PDUFA date expected in fourth quarter |
CASI Pharmaceuticals Inc., of Rockville, Md. |
Marqibo (vincristine sulfate liposome injection) |
Tubulin modulator |
Philadelphia chromosome-negative acute lymphoblastic leukemia |
China's NMPA approved clinical trial application for registration trial |
Cytori Therapeutics Inc., of San Diego |
Doxorubicin hydrochloride Cytori (previously ATI-0918) |
Albumin-stabilized liposomal microtubule inhibitor |
Breast and ovarian cancer, multiple myeloma, Kaposi's sarcoma |
Filed NDA pre-submission request to EMA as precursor to filing marketing authorization application under centralized approval procedure |
Foamix Pharmaceuticals Ltd., of Rehovot, Israel |
FMX-101 |
Tetracycline antibiotic |
Moderate to severe acne vulgaris |
FDA accepted NDA for review, setting PDUFA date of Oct. 20, 2019 |
Genentech, unit of Roche Holding AG, of Basel, Switzerland, and Abbvie Inc., of North Chicago |
Venclexta (venetoclax) |
BCL-2 protein inhibitor |
Chronic lymphocytic leukemia |
Submitted an sNDA to the FDA for use, in combination with Gazyva (obinutuzumab, Roche), in those with previously untreated disease; agency granted breakthrough therapy designation in the indication and plans to review application under Real-Time Oncology Review pilot |
Notes For more information about individual companies and/or products, see Cortellis. |