Generic drug approved by FDA (through August 2009): ethinyl estradiol/norgestimate tablets
Ethinyl estradiol/norgestimate tablets, 0.025/0.18 mg, 0.025/0.215 mg, and 0.025/0.25 mg (trade name, Tri-Lo Sprintec) (equiv to Ortho Tri-Cyclen Lo)
TEVA
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.