Slayback is a New Jersey-based company focused on complex generic and specialty pharmaceutical products with a team of 85 employees and operations in the U.S., India and Europe. Since its inception in 2011, Slayback has demonstrated a spectacular track record of numerous sole first-to-file ANDAs, 505(b)(2)s and complex generic filings, approvals and launches. In the past year, Slayback’s ANDA for Hydroxyprogesterone 5 ml vial was the first generic ANDA to be approved and launched in the U.S., and Slayback continues to hold the largest market share. Previously, Slayback has shown its excellent execution skills through the approval and launch of numerous difficult products such as Propofol Injectable Emulsion.
On April 6, 2023, the U.S. Food and Drug Administration (FDA) issued a final decision ordering the withdrawal of the approval of Makena® (hydroxyprogesterone caproate injection, 250 milligrams (mg) per mL) and its generics. FDA recognizes that there is a supply of product that has already been distributed. Patients who have questions should talk to their healthcare provider. We recommend health care practitioners consider FDA’s conclusions.
If you have questions or concerns about receiving your therapy as prescribed, consult your healthcare provider.