MIRAMAR, Fla., July 27, 2026 /PRNewswire/ — Agency issues “study may proceed” letter; development pathway does not require a clinical endpoint efficacy study.
DifGen Pharmaceuticals LLC today announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s Investigational New Drug (IND) application and issued a “study may proceed” letter for DFGN-101, an intramuscular injection under development for the treatment of advanced or metastatic breast cancer in women.
DFGN-101 is designed to be administered as a single intramuscular injection, compared with the two separate injections required for the currently marketed reference product. If approved, the product would reduce the number of injections a patient receives at each treatment visit.
Under the agreed development pathway, DifGen will proceed with preclinical toxicology studies in rat and rabbit and a Phase 1 pharmacokinetic study. A clinical endpoint/efficacy study is not required. The Agency’s position was supported by the company’s Chemistry, Manufacturing and Controls (CMC) data package and by results from a pilot pharmacokinetic study showing a PK profile comparable to that of the reference product.
The clearance reflects DifGen’s formulation and clinical development capabilities and its focus on identifying efficient development pathways for technically complex programs.
About DifGen Pharmaceuticals
DifGen Pharmaceuticals is a USFDA-compliant manufacturer of generic pharmaceuticals, focused on developing complex formulations. At DifGen Pharmaceuticals, we lead in innovation, providing cost-effective solutions in complex generics and supply chain management to ensure access to essential medicines. Our diverse portfolio spans all dosage forms, backed by expertise in product development, quality assurance, manufacturing, and regulatory compliance. For more information please visit our website www.difgen.com.
Any questions regarding this press release should be directed to Roberta Loomar, Global General Counsel, at +19546051796 or roberta.l@difgen.com
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SOURCE DifGen Pharmaceuticals LLC