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FDA clears McGuff Pharma's generic Delalutin injection

  • The FDA approves privately held McGuff Pharmaceuticals' Abbreviated New Drug Application (ANDA) for hydroxyprogesterone caproate injection USP, 250 mg/mL, the generic equivalent to Delalutin Injection, 250 mg/mL formerly produced by Bristol-Myers Squibb (BMY -0.4%).
  • McGuff does not specify the indications but the latest version of Delatutin's label when it was withdrawn from sale in 2010 stated it was for non-pregnant women for the treatment of advanced adenocarcinoma of the uterine corpus (Stage III or IV), the management of amenorrhea (absence of menstruation) and abnormal uterine bleeding due to hormonal imbalance and for the production of secretory endometrium and desquamation.
  • AMAG Pharmaceuticals (NASDAQ:AMAG) also markets a hydroxyprogesterone caproate injection, 250 mg/mL, under the brand name Makena, but it is indicated for reducing the risk of preterm birth.

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