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STI Pharma announces the launch of Thiotepa for injection.

Newtown, PA, December 16, 2020.

STI Pharma, LLC (“STI”) announced the US launch of Thiotepa for injection, 15 mg strength, for which STI has received final approval by the US Food and Drug Administraion for its Abbreviated New Drug Application, (ANDA). This launch adds to STI’s growing portfolio of generic injectables.

Thiotepa for Injection is the AP rated generic equivalent of the antineoplastic agent Thiotepa According to IQVIA™, a leading healthcare data and analytics provider, U.S. annual sales for Thiotepa for Injection, USP, for the 12 months ending November 2020 were approximately $35 million

Thiotepa for Injection, USP has been tried with varying results in the palliation of a wide variety of neoplastic diseases. However, the most consistent results have been seen in the following tumors:

  • • Adenocarcinoma of the breast.
  • • Adenocarcinoma of the ovary.
  • • For controlling intracavitary effusions secondary to diffuse or localized neoplastic diseases of various serosal cavities.
  • • For the treatment of superficial papillary carcinoma of the urinary bladder.

Important Safety information, death has occurred after intravesical administration, caused by bone-marrow depression from systematically absorbed drug. Death from septicemia and hemorrhage has occurred as a direct result of hematopoietic depression by thiotepa.

Reported adverse reactions include Fatigue, weakness. Febrile reaction and discharge from a subcutaneous lesion may occur, rash, urticaria, laryngeal edema, asthma, anaphylactic shock, wheezing, Contact dermatitis, pain at the injection site, Nausea, vomiting, abdominal pain, anorexia, Dysuria, urinary retention. There have been rare reports of chemical cystitis or hemorrhagic cystitis following intravesical, but not parenteral administration of thiotepa, Prolonged apnea has been reported when succinylcholine was administered prior to surgery, following combined use of thiotepa and other anticancer agents, Dizziness, headache, blurred vision, Dermatitis, alopecia. Skin depigmentation, Conjunctivitis, Amenorrhea, interference with spermatogenesis

See Package Insert (PI) for full prescribing information and complete safety information: