ANI Pharmaceuticals Announces the FDA Approval and Imminent Launch of Fludrocortisone Acetate Tablets USP
ANI’s Fludrocortisone Acetate Tablets are the generic version of the Reference Listed Drug (RLD) Florinef®. The current annual U.S. market for Fludrocortisone Acetate Tablets, 0.1 mg is approximately
"The commercialization of Fludrocortisone Acetate Tablets, the third generic to this RLD, continues to highlight the strength of our research and development engine and our commitment to rapidly bringing limited market competition generic products to our patients in need and to our customers,” stated
To the extent any statements made in this release 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, those relating to the commercialization and potential sales of the product and any additional product launches from the Company’s generic pipeline, 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. Uncertainties and risks include, but are not limited to, the risk that the Company may face with respect to importing raw materials; competition from other products; acquisitions; contract manufacturing arrangements; delays or failure in obtaining product approval from the
More detailed information on these and additional factors that could affect the Company’s actual results are described in the Company’s filings with the