Ranbaxy Launches Absoricatm (Isotretinoin) Capsules in the U.S. Healthcare Market
Gurgaon, India, November 26, 2012
Ranbaxy Laboratories, Inc. (RLI), a wholly owned subsidiary of Ranbaxy Laboratories Limited (RLL), 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® 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®. 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."
Please refer to the Absorica package insert for full prescribing and dispensing instructions at http://dailymed.nlm.nih.gov.
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™. 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.
About Ranbaxy Laboratories Inc.
Ranbaxy Laboratories Inc. (RLI) based in Jacksonville, Florida, is a wholly owned subsidiary of Ranbaxy Laboratories Limited (RLL), India's largest pharmaceutical company. RLI is engaged in the sale and distribution of branded prescription products in the U.S. healthcare system.
About Ranbaxy Laboratories Limited
Ranbaxy Laboratories Limited (RLL), India's largest pharmaceutical company, is an integrated, research based, international pharmaceutical company producing a wide range of quality, affordable generic medicines, trusted by healthcare professionals and patients across geographies. Ranbaxy's continued focus on R&D has resulted in several approvals, in developed and emerging markets many of which incorporate proprietary Novel Drug Delivery Systems (NDDS) and technologies, developed at its own labs. The company has further strengthened its focus on generics research and is increasingly working on more complex and specialty areas. Ranbaxy serves its customers in over 125 countries and has an expanding international portfolio of affiliates, joint ventures and alliances, ground operations in 43 countries and manufacturing operations in 8 countries. Ranbaxy is a member of the Daiichi Sankyo Group. Through strategic in-licensing opportunities and its hybrid business model with Daiichi Sankyo, a leading global pharma innovator headquartered in Tokyo, Japan, Ranbaxy is introducing many innovator products in markets around the world, where it has a strong presence. This is in line with the company's commitment to increase penetration and improve access to medicines, across the globe. For more information, please visit www.ranbaxy.com.
About Cipher Pharmaceuticals Inc.
Cipher Pharmaceuticals (TSX: DND) (OTC: CPHMF) is a growing specialty pharmaceutical company that commercializes novel formulations of successful, currently marketed molecules. Cipher's strategy is to in-license clearly differentiated products, advance them through the clinical development and regulatory approval stages, and out-license to international marketing partners. For more information, please visit www.cipherpharma.com.
Absorica is a trademark of Ranbaxy Laboratories Limited.
Lidose is a registered trademark of SMB Laboratories.
Accutane is a registered trademark of Hoffman-La Roche.
Posted: November 2012
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