Kiel Laboratories Reaches New Milestone With Its 16th New Drug Application Approval

Kiel Laboratories, a leading strategic consulting and pharmaceutical services provider, announced the successful approval of its 16th New Drug Application (NDA) through the U.S. Food and Drug Administration (FDA), solidifying its reputation as a trusted partner in drug development and regulatory strategy.

The approval of Vyscoxa™ marks a significant achievement in both formulation science and regulatory strategy. To address the challenges of developing an oral suspension, the team incorporated a novel excipient, a key component of the system. In combination with other functional ingredients, the formulation delivered improved dose uniformity, long-term stability, controlled dissolution, and better palatability. Because the excipient was critical to the product’s performance, obtaining FDA approval was essential. This process required rigorous regulatory work, including thorough DMF reviews and toxicology evaluations. Bringing this novel excipient from concept to an FDA-approved product showcases Kiel’s expertise in both drug development and regulatory execution.

“The decision confirms the strength of our scientific rigor and its relevance for people living with rheumatic diseases,” said Roy Bryant, senior director of technical services. “This milestone reflects our unwavering commitment to delivering high-quality, patient-centric pharmaceutical solutions.”

“This latest approval highlights Kiel Laboratories’ ability to pair strategic regulatory guidance with execution,” said Greg Thomas, Ph.D., vice president of research and development. “We remain at the forefront, delivering regulatory excellence and accelerating time to market for life-changing therapies.”

Founded in 1991 by Dr. Jeff Kiel, Kiel Laboratories has built a legacy of excellence in pharmaceutical R&D, specializing in 505(b)(2) and orphan drug submissions. As the pharmaceutical industry continues to evolve, Kiel Laboratories remains at the forefront delivering tailored, end-to-end support across strategy, consulting, and execution and accelerating time to market for life-changing therapies.

About Kiel Laboratories

Kiel Laboratories is a pharmaceutical R&D company offering cGMP consulting and non-GMP technical services throughout an entire product lifecycle. With over 30 years of experience and 16 NDA approvals, we provide formulation, analytical, quality, and regulatory support backed by insider expertise from the development of innovative, generic, and OTC products. Acting as an extension of your team, Kiel delivers flexible, end-to-end solutions that anticipate challenges and accelerate your path to market. To explore our services, visit kiellaboratoriesinc.com.

“This latest NDA approval highlights Kiel Laboratories' ability to pair strategic regulatory guidance with execution,” said Greg Thomas, Ph.D., vice president of research and development.

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