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news.US-based Adamis Pharmaceuticals has received a complete response letter (CRL) from the US Food and Drug Administration (FDA) regarding its new drug application (NDA) Epinephrine Injection USP 1:1000 0.3mg pre-filled single dose syringe (PFS) product, for the emergency treatment of acute anaphylaxis.
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In May last year, the company submitted a NDA to the FDA pursuant to Section 505(b)(2) of the Food, Drug & Cosmetic Act, as amended, for approval of the Epinephrine PFS product.
The FDA’s Center for Drug Evaluation and Research issues CRL when it completes its review of a file and questions remain that preclude the approval of the NDA in its current form.
Adamis president and CEO Dr Dennis Carlo said: "We are reviewing the CRL and plan to request a meeting with the FDA to discuss the letter, including clarifying the product delivery volume specifications.
"Although we expect to have more clarity with respect to timing, we believe we can satisfy all of the requests in the CRL and will work closely with the FDA to address the items raised in the CRL and finalize its review of our NDA. Adamis remains committed to bringing the epinephrine PFS to market."
The company said that questions raised by the FDA pertain only to Chemistry, Manufacturing and Controls (CMC) relating to the volume of dose delivered by the syringe, including the ability to deliver volume within the levels contained in the labeling claim and as required by the FDA.
No other safety or efficacy issues were raised, and the NDA will remain open until the CMC issues are resolved.