ANI PHARMACEUTICALS, INC. (NASDAQ:ANIP) Files An 8-K Other Events
Item 8.01.
On April 29, 2020, ANI Pharmaceuticals, Inc. (the “Company”) announced that it received a Refusal to File (“RTF”) letter from the U.S. Food and Drug Administration (“FDA”) regarding its supplemental New Drug Application (“sNDA”) for Cortrophin Gel. Upon its preliminary review, the FDA determined that certain portions of the Chemistry, Manufacturing and Controls section in the sNDA were not sufficiently complete to permit a substantive review. The Company will seek immediate guidance, which potentially includes requesting a Type A meeting with the FDA, to clarify and respond to the issues identified in the RTF letter.
Forward-Looking Statements
To the extent any statements made in this report deal with information that is not historical, these are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements about the Company’s planned response to the RTF letter and other statements that are not historical in nature, particularly those that utilize terminology such as “anticipates,” “will,” “expects,” “plans,” “potential,” “future,” “believes,” “intends,” “continue,” other words of similar meaning, derivations of such words and the use of future dates. Uncertainties and risks may cause the Company’s actual results to be materially different than those expressed in or implied by such forward-looking statements. The Company’s business generally is subject to a number of risks which are described more fully in the Company’s filings with the Securities and Exchange Commission, including its most recent annual report on Form 10-K and quarterly reports on Form 10-Q, as well as its proxy statement. All forward-looking statements in this report speak only as of the date of this report and are based on the Company’s current beliefs, assumptions, and expectations. The Company undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.
| Exhibit | Description |
| 99.1 | Press release dated April 29, 2020. |
ANI PHARMACEUTICALS INC Exhibit
EX-99.1 2 tm2018022d1_ex99-1.htm EXHIBIT 99.1 Exhibit 99.1 ANI Receives Refusal to File Letter from FDA for Cortrophin® Gel BAUDETTE,…
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About ANI PHARMACEUTICALS, INC. (NASDAQ:ANIP)
ANI Pharmaceuticals, Inc. is an integrated specialty pharmaceutical company. The Company is engaged in developing, manufacturing and marketing branded and generic prescription pharmaceuticals. The Company’s focused areas of product development include anti-cancer (oncolytics), hormones and steroids, and complex formulations. Its generic products include Esterified Estrogen with Methyltestosterone, Etodolac, Flecainide, Fluvoxamine, Hydrocortisone Enema, Methazolamide, Metoclopramide Syrup, Nimodipine, Opium Tincture, Oxycodone Oral Solution, Propafenone and Vancomycin. Its branded products include Cortenema, Lithobid, Reglan and Vancocin. It has over two pharmaceutical manufacturing facilities located in Baudette, Minnesota that are capable of producing oral solid dose products, as well as liquids and topicals, controlled substances, and potent products. Its two facilities have a combined manufacturing, packaging and laboratory capacity totaling approximately 173,000 square feet.
