Adamis Announces NDA Resubmission of its Epinephrine Pre-Filled Syringe Application
Adamis Pharmaceuticals Corporation recently announced the resubmission of the company’s New Drug Application (NDA) to the US FDA for its Epinephrine Pre-filled Syringe (PFS) product candidate for the emergency treatment of anaphylaxis. The resubmission is intended to address the issues raised by the FDA in the agency’s June 2016 Complete Response Letter (CRL).
Dr. Dennis J. Carlo, President and CEO of Adamis, stated “We are pleased to resubmit our Epinephrine Pre-filled Syringe NDA. With all of the recent news regarding products in the anaphylaxis market, we believe our product, now so, more than ever, can be a part of the potential solution for patients and payors as there is an obvious need for a low-cost therapeutic alternative like our PFS. I was encouraged by the results of the Human Factors study in that it showed our product to be intuitive in its use. In addition, based on what we have seen, we believe that many individuals would prefer our product over the EpiPen. The Human Factors study consisted of testing in trained and untrained adolescents (12 to 18 years of age), trained and untrained adults, and trained and untrained caretakers.”
Adamis Pharmaceuticals Corporation is a specialty biopharmaceutical company focused on developing and commercializing products in the therapeutic areas of respiratory disease and allergy. The company’s current specialty pharmaceutical product candidates include the Epinephrine Injection PFS syringe product for use in the emergency treatment of anaphylaxis, APC-1000 and APC-5000 for the treatment of asthma and chronic obstructive pulmonary disease, and APC-2000 for the treatment of bronchospasms. The company’s US Compounding, Inc. subsidiary, which is registered as a drug compounding outsourcing facility under Section 503B of the US Food, Drug & Cosmetic Act and the US Drug Quality and Security Act, provides prescription compounded medications, including compounded sterile preparations and non-sterile compounds, to patients, physician clinics, hospitals, surgery centers, and other clients throughout most of the US. USC’s product offerings broadly include, among others, corticosteroids, hormone replacement therapies, hospital outsourcing products, injectables, urological preparations, ophthalmic preparations, topical compounds for pain, and men’s and women’s health products.
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