DURECT CORPORATION (NASDAQ:DRRX) Files An 8-K Other EventsItem 8.01 Other Events
On August 6, 2018, DURECT Corporation issued a press release announcing that its licensee, Pain Therapeutics reported that it has received a Complete Response Letter from the U.S. Food and Drug Administration (FDA) for Pain Therapeutics’ New Drug Application (NDA) for REMOXY® ER (oxycodone) extended-release capsules CII.A copy of the press release is attached as Exhibit 99.1 to this Form 8-K and incorporated herein by reference.
Item 8.01 Financial Statements and Exhibits
(d) Exhibits
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99.1 |
Press Release of DURECT Corporation dated August 6, 2018 |
DURECT CORP ExhibitEX-99.1 2 drrx-ex991_6.htm EX-99.1 drrx-ex991_6.htm Exhibit 99.1 DURECT’s Licensee Pain Therapeutics Receives Complete Response Letter from FDA for REMOXY® ER (oxycodone) Extended-Release Capsules CII CUPERTINO,…To view the full exhibit click here
About DURECT CORPORATION (NASDAQ:DRRX)
Durect Corporation is a biopharmaceutical company with research and development programs. The Company’s products candidates include DUR-928, oral for metabolic/lipid disorders, and DUR-928, injectable for acute organ injuries. Its other product candidates include POSIMIR (controlled release injection of bupivacaine), REMOXY (oral controlled release oxycodone), ORADUR-ADHD, ELADUR (controlled release injection of bupivicane), Relday (risperidone), ORADUR-based opioid (hydromorphone) and SABER-based ophthalmic. The Company’s ALZET product line consists of miniature, implantable osmotic pumps and accessories used for experimental research in mice, rats and other laboratory animals. The Company also manufactures and sells osmotic pumps used in laboratory research and design; and develops and manufactures a range of standard and custom biodegradable polymers and excipients for pharmaceutical and medical device clients for use as raw materials in their products.
