DifGen Pharmaceuticals announced that the FDA has approved its Abbreviated New Drug Application (ANDA) for Mesalamine Extended-Release Capsules USP, 250 mg and 500 mg. The product is therapeutically equivalent, or AB-rated, to PENTASA® (mesalamine) Extended-Release Capsules. The 250 mg strength has also received a Competitive Generic Therapy (CGT) designation, providing a potential period of market exclusivity.
The approval represents DifGen’s second consecutive first-cycle FDA approval for a complex generic, underscoring the company’s scientific and regulatory capabilities. DifGen emphasized that the product’s development required overcoming significant formulation and bioequivalence challenges due to mesalamine’s low systemic absorption and variable pharmacokinetics.
“This approval and imminent launch bring our founding vision of ‘Difficult and Differentiated Generics’ to life,” said Ramandeep Singh Jaj, Founder and Co-CEO of DifGen. “We’re proud to expand our portfolio by navigating complex regulatory pathways and delivering affordable, high-quality treatments to patients.”
Dr. Santhanakrishnan Srinivasan, Founder and Co-CEO, noted that the milestone demonstrates the company’s depth in scientific and manufacturing innovation. “Our team developed a robust process and clinical framework to address mesalamine’s inherent challenges in bioavailability and variability,” he said.
The newly approved Mesalamine Extended-Release Capsules strengthen DifGen’s portfolio of complex generics and advance its mission to improve patient access to affordable therapies in the United States.
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