ADAMIS PHARMACEUTICALS CORPORATION (NASDAQ:ADMP) Files An 8-K Other Events
Item 8.01
On December 19, 2019, Adamis Pharmaceuticals Corporation (the “Company”) issued a press release providing an update on the ZIMHI™ New Drug Application (“NDA”) resubmission process.
On November 22, 2019, the Company received a Complete Response Letter (“CRL”) from the U.S. Food and Drug Administration (“FDA”) regarding its NDA for its ZIMHI™ high-dose naloxone injection product for the treatment of opioid overdose. The Company has provided responses to the comments included in the CRL and submitted these answers to the FDA. With the responses, the Company requested a Type A meeting with the FDA and is currently waiting for the FDA to respond to this request. The next update from the Company on the ZIMHI NDA resubmission process will be sometime after the FDA meeting occurs. At that time, the Company would expect to have more information regarding the timeline for the full resubmission of the NDA back to the FDA.
A copy of the Company’s press release is attached hereto as exhibit 99.1 and incorporated herein by reference.
(d) Exhibits.
| 99.1 | Press release dated December 19, 2019. |
Adamis Pharmaceuticals Corp Exhibit
EX-99.1 2 ex99-1.htm PRESS RELEASE DATED DECEMBER 19,…
To view the full exhibit click here
About ADAMIS PHARMACEUTICALS CORPORATION (NASDAQ:ADMP)
Adamis Pharmaceuticals Corporation is a pharmaceutical company. The Company is engaged in the development of its specialty pharmaceutical products. The Company is developing various products in the allergy and respiratory markets, including a dry powder inhaler technology that it acquired from 3M Company (3M). The Company’s product portfolio includes specialty pharmaceutical products, such as Epinephrine pre-filled syringe (PFS), APC-5000 dry powder inhaler (DPI), APC-1000 and APC-2000, and biotechnology products, such as TeloB-VAX (vaccine), APC-100, APC-200 and APC-300. The Company’s lead product candidate, the Epinephrine Injection USP 1:1000 0.3 milligram Pre-filled Single Dose Syringe, or the Epinephrine PFS, is a pre-filled syringe designed to deliver a premeasured 0.3 milligrams dose of epinephrine for the treatment of anaphylaxis. The Company also has licensed vaccine technology called somatic transgene immunization (STI) technology.
