ANI Pharmaceuticals Announces FDA Approval and Imminent Launch of Dexamethasone Tablets USP
ANI’s Dexamethasone Tablets USP 1.5mg, 4mg and 6mg are the generic version of the Reference Listed Drug (RLD) Decadron®. The current annual U.S. market for Dexamethasone Tablets USP 1.5mg, 4mg and 6mg is approximately
"The FDA approval and imminent launch of Dexamethasone Tablets further demonstrates our commitment to serve patients in need by bringing limited competition products to market. Our R&D team continues to build on their strong track record and we ranked sixth among all companies in terms of the number of ANDA approvals received in the past 12 months,” 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 and maintaining 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
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