Recro Pharma, Inc. (NASDAQ:REPH) Files An 8-K Other Events

ME Staff 8-k
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Recro Pharma, Inc. (NASDAQ:REPH) Files An 8-K Other Events

Recro Pharma, Inc. (NASDAQ:REPH) Files An 8-K Other Events
Item 8.01

On October 31, 2019, Recro Pharma, Inc. (the “Company”) issued a press release announcing it has received a written decision from the U.S. Food and Drug Administration granting its appeal of the Complete Response Letter relating to the New Drug Application seeking approval for intravenous meloxicam. A copy of the press release is filed as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.

(d) Exhibits

The following exhibits are being filed herewith:

99.1    Press release of Recro Pharma, Inc., dated October 31, 2019.


Recro Pharma, Inc. Exhibit
EX-99.1 2 d816459dex991.htm EX-99.1 EX-99.1 Exhibit 99.1   FDA Grants Appeal to Recro Pharma for IV Meloxicam New Drug Application Received Positive Response from FDA Regarding IV Meloxicam Formal Dispute Resolution Request Company Remains on Track to Execute Spin Out of Acute Care Business Segment During the Fourth Quarter of 2019 MALVERN,…
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About Recro Pharma, Inc. (NASDAQ:REPH)

Recro Pharma, Inc. is a clinical-stage specialty pharmaceutical company. The Company is engaged in developing products for hospitals and ambulatory care settings that is developing non-opioid products for treatment of serious acute pain. The Company’s lead product candidate is an injectable form of meloxicam. Its product candidates for pain indications include injectable meloxicam, a product candidate in development for the treatment of acute post-operative pain; Dex-IN, a product candidate under development for the treatment of post-operative pain; Dex-SL, a product candidate for the treatment of chronic pain, and Fadolmidine (Fado), a product candidate used by injection into the spine for pain associated with surgery or certain types of chronic pain and which the Company pursues as a topical product for local application to treat serious pain associated with nerve damage to local tissues (neuropathies), especially of the lower extremities, which can occur in diabetic patients.