FDA approved Absorica LD (isotretinoin) for Severe Recalcitrant Nodular AcneFDA approved new acne drug Absorica LD for severe nodular acne.

FDA From the archive Source published November 5, 2019 Summary added June 16, 2026 DOI ↗ Editorial oversight: Dr. Amelia Tan, PhD · Internal Medicine & Chronic Disease

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Key Takeaway

Note that Absorica LD is not substitutable with Absorica due to different bioavailability and dosing.

The FDA has approved Absorica LD (isotretinoin) for the treatment of severe recalcitrant nodular acne in non-pregnant patients aged 12 years and older. The drug is indicated for patients with multiple inflammatory nodules 5 mm or greater in diameter who have not responded to conventional therapy, including systemic antibiotics. Absorica LD is a retinoid and is not substitutable with Absorica due to different bioavailability and dosing recommendations. The approval is based on a double-blind, randomized trial comparing Absorica with another isotretinoin product; detailed efficacy data are not available in the label. Clinicians should note that a second course is not recommended before a two-month waiting period, as acne may continue to improve after initial therapy.

＋ Clinical Details (Mechanism · Dosing · Trial Data · Warnings)

Mechanism of Action

Isotretinoin is a retinoid. The exact mechanism of action in acne is not fully understood, but it is thought to reduce sebum production, normalize follicular keratinization, and inhibit Propionibacterium acnes growth.

Indication & Patient Population

Absorica LD is indicated for the treatment of severe recalcitrant nodular acne in non-pregnant patients 12 years of age and older with multiple inflammatory nodules with a diameter of 5 mm or greater. It is reserved for patients unresponsive to conventional therapy, including systemic antibiotics.

Dosing & Administration

The recommended dosage of Absorica LD is 0.4 to 0.8 mg/kg/day given in two divided doses with or without meals for 15 to 20 weeks. Adult patients with very severe disease (scarring, trunk involvement) may increase dosage to 1.6 mg/kg/day in divided doses. Once daily dosing is not recommended. If a dose is missed, skip that dose; do not double up. Prior to prescribing, perform pregnancy testing, fasting lipid profile, and liver function tests.

Key Clinical Trial Data

The effectiveness of Absorica LD for severe recalcitrant nodular acne in patients 12 years and older is based on a double-blind, randomized, parallel group trial (Study 1) in subjects who received Absorica or another isotretinoin capsule product. Detailed efficacy results are not available in the label.

Warnings & Contraindications

Absorica LD is contraindicated in pregnant women due to teratogenicity. Pregnancy testing must be performed prior to, monthly during, at end of therapy, and one month after discontinuation. Other warnings include increased triglycerides, liver function abnormalities, and potential for bone loss with long-term use. Because of significant adverse reactions, it is reserved for patients unresponsive to conventional therapy.

Place in Therapy

Absorica LD is a second-line therapy for severe recalcitrant nodular acne after failure of conventional treatments including systemic antibiotics. It is not recommended for first-line use. A two-month waiting period is advised before considering a second course.

The FDA has approved a new drug called Absorica LD (isotretinoin) to treat severe nodular acne. This type of acne causes large, painful bumps under the skin that can lead to scarring. The drug is for patients aged 12 years and older who have not gotten better with other treatments, including antibiotics.

Absorica LD is a retinoid, which means it works by reducing oil production and helping skin cells shed normally. It is not the same as the older drug Absorica, so patients should not switch between them without a doctor's guidance. The approval was based on a study comparing Absorica LD to another isotretinoin product.

For patients, this approval means there is a new option for hard-to-treat acne. However, it is important to know that acne may continue to improve even after the first course of treatment. Doctors recommend waiting at least two months before considering a second course.

If you have severe nodular acne, talk to your doctor about whether Absorica LD might be right for you. Your doctor can explain the benefits and risks, and help you decide on the best treatment plan.

What this means for you:

Absorica LD is a new option for severe acne, but talk to your doctor to see if it is right for you.

Study Details

Study typeFda approval

PublishedNov 2019

View Original Abstract ↓

1 INDICATIONS AND USAGE ABSORICA and ABSORICA LD are indicated for the treatment of severe recalcitrant nodular acne in non-pregnant patients 12 years of age and older with multiple inflammatory nodules with a diameter of 5 mm or greater. Because of significant adverse reactions associated with its use, ABSORICA and ABSORICA LD are reserved for patients with severe nodular acne who are unresponsive to conventional therapy, including systemic antibiotics. Limitations of Use : If a second course of ABSORICA/ABSORICA LD therapy is needed, it is not recommended before a two-month waiting period because the patient’s acne may continue to improve following a 15 to 20-week course of therapy [see Dosage and Administration (2.2) ]. ABSORICA and ABSORICA LD are retinoids indicated for the treatment of severe recalcitrant nodular acne in non-pregnant patients 12 years of age and older with multiple inflammatory nodules with a diameter of 5 mm or greater. Because of significant adverse reactions associated with its use, ABSORICA and ABSORICA LD are reserved for patients with severe nodular acne who are unresponsive to conventional therapy, including systemic antibiotics. (1) Limitations of Use: If a second course of ABSORICA/ABSORICA LD therapy is needed, it is not recommended before a two-month waiting period because the patient’s acne may continue to improve following a 15 to 20-week course of therapy. (1)

FDA approved Absorica LD (isotretinoin) for Severe Recalcitrant Nodular AcneFDA approved new acne drug Absorica LD for severe nodular acne.

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FDA approved Absorica LD (isotretinoin) for Severe Recalcitrant Nodular AcneFDA approved new acne drug Absorica LD for severe nodular acne.

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