BAUDETTE, Minn., March 5, 2015 /PRNewswire/ -- ANI Pharmaceuticals, Inc. ("ANI") (NASDAQ: ANIP) today announced that it has acquired the approved abbreviated new drug application ("ANDA") for Flecainide Acetate tablets USP 50mg, 100mg and 150mg, previously marketed by Teva Pharmaceuticals. According to IMS Health, the overall market for this product was approximately $39 million in 2014.
Arthur S. Przybyl, President and CEO of ANI Pharmaceuticals, stated, "This acquisition further expands our near-term generic pipeline. We intend to re-launch the product within the next 12 months. We are excited that this transaction further extends the ANI-Teva relationship."
ANI has forty-seven generic drug products under development addressing a total annual market size of approximately $3.0 billion, based on data from IMS Health.
About Flecainide Tablets USP
Flecainide acetate is an antiarrhythmic drug indicated for use in patients without structural heart disease for the prevention of paroxysmal supraventricular tachycardias (PSVT), including atrioventricular reentrant tachycardia and other supraventricular tachycardias of unspecified mechanism associated with disabling symptoms as well as paroxysmal atrial fibrillation/flutter (PAF) associated with disabling symptoms. Flecainide acetate tablets USP are also indicated for the prevention of documented ventricular arrhythmias, such as sustained ventricular tachycardia (sustained VT), that in the judgment of the physician are life-threatening.
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; 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.
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SOURCE ANI Pharmaceuticals