DifGen Pharmaceuticals LLC announced today that the U.S. Food and Drug Administration has accepted the company's Investigational New Drug application and issued a study may proceed letter for DFGN-101. This intramuscular injection is under development to treat advanced or metastatic breast cancer in women.

DFGN-101 is formulated for delivery as one intramuscular injection rather than the two separate injections required by the current reference product. If approved the treatment would lower the number of injections patients receive during each visit.

Under the agreed development plan DifGen will complete preclinical toxicology studies in rat and rabbit models plus a Phase 1 pharmacokinetic study. A clinical endpoint efficacy study is not required. The agency decision rests on the company's Chemistry Manufacturing and Controls data package together with results from a pilot pharmacokinetic study that showed a comparable profile to the reference product.

The clearance underscores DifGen's formulation expertise and its ability to identify efficient development routes for technically demanding programs.

About DifGen Pharmaceuticals

DifGen Pharmaceuticals is a USFDA-compliant manufacturer of generic pharmaceuticals focused on complex formulations. The company drives innovation by delivering cost-effective solutions in complex generics and supply chain management to improve access to essential medicines. Its portfolio covers all dosage forms and is supported by deep expertise in product development quality assurance manufacturing and regulatory compliance. Further information is available on the company website.

Questions regarding this press release should be directed to Roberta Loomar Global General Counsel at +19546051796 or via email.

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SOURCE DifGen Pharmaceuticals LLC