Healthcare Industry News: U.S. Food and Drug Administration
News Release - June 27, 2018
ANI Pharmaceuticals Announces Launch of Cholestyramine for Oral Suspension USPBAUDETTE, Minn., June 27, 2018 -- (Healthcare Sales & Marketing Network) -- ANI Pharmaceuticals, Inc. ("ANI") (Nasdaq: ANIP) today announced the launch of Cholestyramine for Oral Suspension USP, 4g/dose, in cans. The current annual U.S. market for this product is approximately $22 million, according to Iqvia/IMS Health.
Arthur S. Przybyl, ANI's President and CEO stated, "This launch is the tenth product that ANI has successfully completed a manufacturing site transfer and recommercialized. These product launches are from previously discontinued ANDA's that ANI has acquired over the last several years. We continue to commit product development resources in order to launch additional discontinued ANDA's that we believe can provide us with meaningful cash flow once re-commercialized."
About Cholestyramine for Oral Suspension USP
Cholestyramine for Oral Suspension USP is indicated as adjunctive therapy to diet for the reduction of elevated serum cholesterol in patients with primary hypercholesterolemia (elevated low density lipoprotein [LDL] cholesterol) who do not respond adequately to diet.
Cholestyramine for Oral Suspension USP may be useful to lower LDL cholesterol in patients who also have hypertriglyceridemia, but it is not indicated where hypertriglyceridemia is the abnormality of most concern.
Cholestyramine for Oral Suspension USP monotherapy has been demonstrated to retard the rate of progression and increase the rate of regression of coronary atherosclerosis.
Cholestyramine for Oral Suspension USP is also indicated for the relief of pruritus associated with partial biliary obstruction.
ANI Pharmaceuticals, Inc. (the "Company" or "ANI") is an integrated specialty pharmaceutical company developing, manufacturing, and marketing branded and generic prescription pharmaceuticals. The Company's targeted areas of product development currently include narcotics, oncolytics (anti-cancers), hormones and steroids, and complex formulations involving extended release and combination products. For more information, please visit our website www.anipharmaceuticals.com.
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, statements about price increases, the Company's future operations, products financial position, operating results and prospects , the Company's pipeline or potential markets therefor, 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. Uncertainties and risks include, but are not limited to, the risk that the Company may face with respect to importing raw materials; increased competition; acquisitions; contract manufacturing arrangements; delays or failure in obtaining product approval from the U.S. Food and Drug Administration; general business and economic conditions; market trends; products development; regulatory and other approvals and marketing.
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 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 news release speak only as of the date of this news release 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.
Source: ANI Pharmaceuticals
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