ANI Pharma Announces Approval And Launch Of Oxycodone Hydrochloride Oral Solution, 100 Mg/5ml
Published: Sep 01, 2017
BAUDETTE, Minn., Sept. 1, 2017 /PRNewswire/ -- ANI Pharmaceuticals, Inc. ("ANI") (Nasdaq: ANIP) today announced that it has received approval from the U.S. Food and Drug Administration ("FDA") of its Abbreviated New Drug Application ("ANDA") for Oxycodone Hydrochloride Oral Solution USP, 100 mg/5 mL (20 mg/mL). The current annual U.S. market for this product is approximately $14.5 million, according to IMS Health. ANI expects to begin shipping to its customers immediately.
Arthur S. Przybyl, ANI's President and CEO stated, "We are pleased to announce the launch of our fourth generic product this year. The product was developed internally at ANI and leverages both our liquid manufacturing and controlled substance capabilities."
About Oxycodone HCl Oral Solution
Oxycodone Hydrochloride Oral Solution 100 mg/5 mL (20 mg/mL) is an opioid agonist indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.
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.
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SOURCE ANI Pharmaceuticals, Inc.