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BAUDETTE, Minn. , Jan. 16, 2024 (GLOBE NEWSWIRE) — ANI Pharmaceuticals, Inc. (ANI or the company) (Nasdaq: ANIP) announced that it has obtained approval from the U. S. Food and Drug Administration. U. S. Food and Drug Administration (FDA) for the New Abbreviated Product. Drug Application (ANDA) for Indomethacin Oral Suspension (OS), USP.
ANI’s Indomethacin OS is the generic edition of Indocin® oral suspension of the Scheduled Reference Medicinal Product (RLD). The annual market in the U. S. The U. S. Pension for Indomethacin OS is approximately $4. 1 million, according to the most recent estimates from IQVIA/IMS Health, a leading healthcare provider. Knowledge and analysis.
“With this approval, the FDA has granted Indomethacin OS a Competitive Generic Therapy (CGT) designation, with exclusivity for 180 days. ANI continues to hold the second-highest number of CGT approvals in the US generic market. highlighting the functions and execution of “Our R&P team
About ANIANI Pharmaceuticals, Inc. (Nasdaq: ANIP) is a diversified biopharmaceutical company serving patients in need by developing, manufacturing, and marketing high quality branded and generic prescription pharmaceutical products, including for diseases with high unmet medical need. Our team is focused on delivering sustainable growth by scaling up our Rare Disease business through the successful launch of our lead asset, Purified Cortrophin® Gel, strengthening our generics business with enhanced research and development capability, innovation in established brands and leveraging our North American manufacturing capabilities. For more information, please visit our website www.anipharmaceuticals.com.
Forward-Looking Statements To the extent that statements made in this press release refer to data that are not current, they are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to: those relating to the marketing and potential sales of the product and any additional product launches from the Company’s generic portfolio, other statements that are not of an old-fashioned nature, specifically those that use terminology such as “anticipates,” “will,” “expects,” “plans,” “forward-looking,” “long-term,” “believes,” “intends to,” “continue,” other words of meaning, derivations of those words, and the use of long-term dates.
Uncertainties and threats could cause the Company’s actual effects to differ materially from those expressed or implied by such forward-looking statements. Uncertainties and threats include, but are not limited to, the threat that the Company would possibly face with respect to the importation of raw fabrics and other ingredients and materials required to manufacture our products; delays or failures in obtaining and maintaining product approval by the United States Food and Drug Administration (“FDA”); policy adjustments or moves adopted through the FDA and other regulatory agencies, including drug recalls; the ability of our manufacturing partners to meet the demands and timelines of our products; acceptance of our products in degrees that allow us to achieve profits; the objective of the festival we are facing and the legal, regulatory and/or legislative methods used through our competition to save it or delay the festival from generic opportunities to branded products; the effect of legislative or regulatory reforms on the pricing of pharmaceutical products; disruptions with product quality, production or supply, or patient protection issues; General business and economic conditions, adding the continued impact and uncertainties related to the COVID-19 pandemic and inflationary pressures, as well as geopolitical conditions, adding the clash between Russia and Ukraine.
More detailed data on those and other items that may be the Company’s actual effects on the Company’s filings with the Securities and Exchange Commission (“SEC”) are described, adding its most recent Annual Report on Form 10-K and its Quarterly Reports on Form 10. -Q, as well as other SEC filings. All forward-looking statements contained in this press release speak only as of the date of this press release and are based on the Company’s existing beliefs, assumptions and expectations. The Company assumes no responsibility to update or revise any forward-looking statements, whether as a result of new data, long-term events or otherwise.
Investor Relations: Lisa M. Wilson, In-Site Communications, Inc. T: 212-452-2793E: lwilson@insitecony. com
Source: ANI Pharmaceuticals, Inc.