Anti-sense compound (LR3001, Genta) for the treatment of chronic myelocytic leukemia
Dantrolene capsules 25, 50, and 100 mg (equiv to Dantrium capsules)
IMPAX
Griseofulvin oral suspension 125 mg/5 mL (equiv to Grifuvin V)
STIEFEL
Octreotide injection (preservative free) 0.05, 0.1, and 0.5 mg/mL (equiv to Sandostatin)
BEDFORD
FDA Issues Complete Response Letter for Pz-Cel to Treat Epidermolysis Bullosa
April 22nd 2024Prademagene zamikeracel is a cell therapy designed to incorporate the functional collagen-producing COL7A1 gene into a patient’s own skin cells. The FDA is asking for additional information on manufacturing practices.