Ranbaxy Laboratories, Inc. (RLI) today announced the sales and promotion launch of Absorica (Isotretinoin) Capsules.
A product that is licensed from Cipher Pharmaceuticals Inc. of Mississauga, Ontario.
Absorica is indicated for the treatment of severe recalcitrant nodular acne in patients 12 years of age and older.
Due to its high lipophilicity, oral absorption of isotretinoin is enhanced when given with a high-fat meal, however, Absorica, which is formulated using patented Lidose(r) technology, can be given without regards to meals. The fasted AUC0-t of Absorica is approximately 83% greater than that of Accutane, while both products are bioequivalent under fed conditions. Absorica is therefore not interchangeable and not substitutable with generic products of Accutane(r). Absorica, NDA, was approved based on a large pivotal clinical trial enrolling 925 patients.
Senior Director, Ranbaxy Laboratories Inc. Dr. Ashish Anvekar said, "We are most pleased to make Absorica available as a valuable option for dermatologists and a subset of patients who suffer from severe recalcitrant nodular acne. Absorica will be the flagship brand of the Ranbaxy dermatology product portfolio in the U.S."
Isotretinoin must not be used by female patients who are or may become pregnant. There is an extremely high risk that severe birth defects will result if pregnancy occurs while taking isotretinoin in any amount, even for a short period 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. Because of this toxicity, isotretinoin can only be marketed under a special restricted distribution program. This program is called iPLEDGE(tm).
Under this program, prescribers must be registered and activated with the iPLEDGE program and can prescribe isotretinoin only to registered patients who meet all the requirements of iPLEDGE.
Isotretinoin can be dispensed only by a pharmacy registered and activated with iPLEDGE. Registered and activated pharmacies can only receive isotretinoin from wholesalers registered with iPLEDGE.
Patients on isotretinoin have been known to become depressed or to develop other serious mental health problems. Some people have had thoughts of hurting themselves or putting an end to their own lives.
Some people tried to end their own lives and some have ended their own lives. There have been reports that people on isotretinoin were aggressive or violent. No one knows if isotretinoin caused these problems or behaviors or if they would have happened even if the person did not take isotretinoin.
Isotretinoin use has been associated with pseudotumor cerebri, a condition caused by increased pressure on the brain. This condition may occur more often in patients also taking tetracycline.
Patients should be aware of other serious side effects, including problems with the skin, pancreas, liver, stomach, bones, muscles, hearing, vision, lipids, allergic reactions, blood sugar, or red and white blood cells. The most common, less serious adverse events include dry skin, chapped lips, dry eyes, and dry nose that may lead to nosebleeds. Patients should be advised about these adverse events and routinely monitored by a doctor during treatment with isotretinoin.
Isotretinoin has been associated with inflammatory bowel disease (including regional ileitis) in patients without a prior history of intestinal disorders. In some instances, symptoms have been reported to persist after isotretinoin treatment has been stopped.