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ANI Pharmaceuticals Announces the FDA Approval and Launch of Levocarnitine Tablets USP

Tuesday, December 20, 2022

ANI Pharmaceuticals, Inc., announced that it received U.S. Food and Drug Administration (FDA) approval for the Abbreviated New Drug Application (ANDA) for Levocarnitine Tablets USP, 330 mg.

ANI’s Levocarnitine Tablets are the generic version of the Reference Listed Drug (RLD) Carnitor®. The current annual U.S. market for Levocarnitine Tablets is approximately $10.0 million, according to IQVIA/IMS Health, a leading healthcare data and analytics provider.

"The launch of Levocarnitine Tablets is another example of ANI’s commitment to increasing patient access to affordable, high-quality medicines and aligns with our goal of bringing limited-competition products to market,” stated Nikhil Lalwani, President and Chief Executive Officer of ANI.

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