UPSHER-SMITH LAUNCHES ISOTRETINOIN CAPSULES, USP
24 Jul 2023
Drug Approval
MAPLE GROVE, Minn., July 24, 2023 /PRNewswire/ -- Upsher-Smith Laboratories, LLC (Upsher-Smith) today announced the recent launch of Isotretinoin Capsules, USP in 10 mg, 20 mg, 30 mg, and 40 mg strengths. The Therapeutic Equivalence (TE) code for these Upsher-Smith products is AB1, and the original Reference Listed Drug (RLD) was the brand Accutane® (isotretinoin capsules USP).* This product launch is part of a multi-year, multi-product collaboration between Upsher-Smith and New Zealand-based, Douglas Pharmaceuticals Ltd. (Douglas). Douglas is a leading producer of isotretinoin around the globe.
The total isotretinoin capsule market had U.S. sales of approximately $299 million for the 12 months ending April 2023 according to IQVIA.
Product Information
For questions about ordering, please call Upsher-Smith at 1-800-654-2299.
Please refer to the full Prescribing Information, including Boxed Warning for Isotretinoin Capsules here. You can also call 1-888-650-3789 to obtain a copy of the full Prescribing Information including Medication Guide.
You are encouraged to report suspected adverse reactions to Upsher-Smith Laboratories, LLC at 1-855-899-9180 or to the FDA by visiting .
About Upsher-Smith
Upsher-Smith Laboratories, LLC is a trusted U.S. pharmaceutical company that strives to improve the health and lives of patients through an unwavering commitment to high-quality products and sustainable growth. The company brings brands and generics to a wide array of customers, always backed by its attentive level of service, strong industry relationships, and dedication to uninterrupted supply. For more information, visit .
*Accutane is a registered trademark of Retrobrands USA LLC. Accutane Capsules have been discontinued.
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