Upsher-Smith Launches Isotretinoin Capsules

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Jun 25, 2021, 10:00 ET

MAPLE GROVE, Minn., June 25, 2021 /PRNewswire/ -- Upsher-Smith Laboratories, LLC (Upsher-Smith) today announced the launch of Isotretinoin Capsules. Upsher-Smith's product is AB2-rated to the branded product, Absorica^®(isotretinoin) capsules.

The isotretinoin capsule market had U.S. sales of approximately $156 million for the 12 months ending April 2021 according to IQVIA.

Product Information

Product	Strength	NDC #	Package Size
Isotretinoin Capsules	40 mg	0245-0575-01	Box of 30 Capsules

For questions about ordering, please call Upsher-Smith at 1-800-654-2299.

WARNING: EMBRYO-FETAL TOXICITY – CONTRAINDICATED IN PREGNANCY

See full prescribing information for complete boxed warning.

• Isotretinoin capsules can cause life–threatening birth defects and is contraindicated in pregnancy. There is an extremely high risk that severe birth defects will result if pregnancy occurs while taking isotretinoin capsules in any amount, even for short periods of time. Potentially any fetus exposed during pregnancy can be affected. There are no accurate means of determining whether an exposed fetus has been affected.

• Isotretinoin capsules are available only through a restricted program called the iPLEDGE REMS.

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.

You are encouraged to report suspected adverse reactions to Upsher-Smith Laboratories, LLC at 1-855-899-9180 or to the FDA by visiting http://www.fda.gov/medwatch.

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 generics and brands 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 www.upsher-smith.com.

Absorica^® is a registered trademark of Sun Pharmaceutical Industries, Inc.

SOURCE Upsher-Smith Laboratories, LLC