ANI Pharmaceuticals Announces FDA Approval and Commercialization of Two ANDAs with CGT Exclusivity
ANI’s Methsuximide Capsules are the generic version of the Reference Listed Drug (RLD) Celontin® Capsules and ANI’s Alendronate Sodium Oral Solution is the generic version of the RLD Fosamax® Oral Solution. The current annual U.S. market for Methsuximide Capsules and Alendronate Sodium Oral Solution is approximately
"The FDA approval and launch of Methsuximide Capsules and Alendronate Sodium Oral Solution represent our ability to drive generics business growth through superior new product launch execution. Our R&D team continues to build strong momentum, and with these launches, we expect to share the top spot in CGT approvals,” 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 and other ingredients and supplies necessary for manufacture of our products; 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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