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ClaravisThis page contains recent news articles, when available, and an overview of Claravis but does not offer medical advice. You should contact your physician with regard to any health issues or concerns.Overview: Claravis (when available) Tretinoin, also known as all-trans-retinoic acid (ATRA), is a naturally occurring derivative of vitamin A (retinol). Retinoids such as tretinoin are important regulators of cell reproduction, proliferation, and differentiation and are used to treat acne and photodamaged skin and to manage keratinization disorders such as ichthyosis and keratosis follicularis. Tretinoin also represents the class of anticancer drugs called differentiating agents and is used in the treatment of acute promyelocytic leukemia (APL). For the the induction of remission in patients with acute promyelocytic leukemia (APL), French-American-British (FAB) classification M3 (including the M3 variant); For the topical treatment of acne vulgaris, flat warts and other skin conditions (psoriasis, ichthyosis congenita, icthyosis vulgaris, lamellar icthyosis, keratosis palmaris et plantaris, epidermolytic hyperkeratosis, senile comedones, senile keratosis, keratosis follicularis (Darier's disease), and basal cell carcinomas.); For palliative therapy to improve fine wrinkling, mottled hyperpigmentation, roughness associated with photodamage. Mechanism Of Action: Tretinoin binds to alpha, beta, and gamma retinoic acid receptors (RARs). RAR-alpha and RAR-beta have been associated with the development of acute promyelocytic leukemia and squamous cell cancers, respectively. RAR-gamma is associated with retinoid effects on mucocutaneous tissues and bone. Although the exact mechanism of action of tretinoin is unknown, current evidence suggests that the effectiveness of tretinoin in acne is due primarily to its ability to modify abnormal follicular keratinization. Comedones form in follicles with an excess of keratinized epithelial cells. Tretinoin promotes detachment of cornified cells and the enhanced shedding of corneocytes from the follicle. By increasing the mitotic activity of follicular epithelia, tretinoin also increases the turnover rate of thin, loosely-adherent corneocytes. Through these actions, the comedo contents are extruded and the formation of the microcomedo, the precursor lesion of acne vulgaris, is reduced. Tretinoin is not a cytolytic agent but instead induces cytodifferentiation and decreased proliferation of APL cells in culture and in vivo. When Tretinoin is given systemically to APL patients, tretinoin treatment produces an initial maturation of the primitive promyelocytes derived from the leukemic clone, followed by a repopulation of the bone marrow and peripheral blood by normal, polyclonal hematopoietic cells in patients achieving complete remission (CR). The exact mechanism of action of tretinoin in APL is unknown. News Articles on Tretinoin Decrease chance of birth defects - Jan 21, 2008 The acne drug isotretinoin (sold under the brand names Accutane, Amnesteem, Claravis and Sotret) poses a high risk of serious birth defects. Jackson Clarion Ledger, New products join acne fight - Jul 24, 2007 MLive.com,Kraker's clear complexion started emerging when her dermatologist prescribed a daily dosage of Claravis, one of a handful of retinoids used to treat severe Purchasing isotretinoin online is risky, FDA warns - Apr 4, 2007 AAP News (subscription)...will appear in online search results for Accutane (isotretinoin) or one of the generic-name versions, Amnesteem, Claravis or Sotret. FDA CAPSULES - Apr 3, 2007 Newsday,Isotretinoin is sold as Accutane, Amnesteem, Claravis and Sotret. VOLUNTARY RECALL OF RHINO MAX SUPPLEMENT. Cosmos Trading Inc. is recalling its supplement Web Page By FDA Warns Of Online Purchase And Use Of Generic Form ... - Apr 2, 2007 All Headline NewsThe drug isotretinoin is sold under the brand name Accutane and three generic names: Amnesteem, Claravis and Sotret. The web page from the FDA also guides FDA Launches Web Page Warning Against Buying Accutane And Its Generic - Apr 2, 2007 WebWire (press release),...under any one of its four names (Isotretinoin is sold under the brand name of Accutane and in generic versions called Amnesteem, Claravis, and Sotret. Roche's Accutane Isn't Safe to Buy Online, US Warns (Update1) - Mar 28, 2007 BloombergInternet users who search for information on Accutane or its generic equivalents, called Amnesteem, Claravis, and Sotret, will see a link to the new FDA Web Web Page Launched for Accutane - Mar 30, 2007 Facts and Comparisons,The page will appear in online search results for Accutane (isotretinoin) or one of its generic versions (Amnesteem, Claravis, or Sotret) and stresses this Online Roaccutane warning - Mar 29, 2007 Health24.com,...someone searches for Accutane (the American version of Roaccutane), or any other generic form of isotretinoin, such as Amnesteem, Claravis or Sotret. FDA MedWatch: Accutane (isotretinoin)- Webpage Warning Against ... - Mar 28, 2007 PharmaLive.com (press release),...will appear in online search results for Accutane (isotretinoin) or one of the generic versions, Amnesteem, Claravis, and Sotret. FDA discourages consumers from purchasing Accutane online - Apr 2, 2007 News-Medical.net,...generic versions -- Amnesteem from Mylan Laboratories, Claravis from Barr Pharmaceuticals and Sotret from Ranbaxy Laboratories -- according to FDA. Junk food ads dominate children's television. - Mar 29, 2007 Hellenic News of America,The new Web page also will pop up for "other generic forms of isotretinoin, such as Amnesteem, Claravis or Sotret." The Wall Street Journal (3/29) and Debate again shadows Accutane 24 Sep 2006 Accutane and Amnesteem, Sotret and Claravis – the three generics approved in the past four years – are the only effective treatment for severe recalcitrant ... -Fort Wayne Journal Gazette FDA Needs To Ban Accutane Sep 23, 2006 ...in patients. Isotretinoin is also sold under the brand names of Accutane, Roaccutane, Amnesteem, Claravis and Sotret. The purpose ... -Media Monitors Network Popular Acne Drug, Isotretinoin, Linked To Depression In Animal ... Sep 19, 2006 Isotretinoin is also sold under the brand names: Accytane, Roaccutane, Amnesteem, Claravis and Sotret. The drug is usually used for teenagers with severe acne. ... -Medical News Today Accutane Restrictions Creating Problems Aug 29, 2006 ...or take isotretinoin. Isotretinoin is sold as Accutane and in three generic versions: Amnesteem, Claravis and Sotret. Doctors and ... -Sci-Tech Today Accutane restrictions creating problems Aug 28, 2006 ...or take isotretinoin. Isotretinoin is sold as Accutane and in three generic versions: Amnesteem, Claravis and Sotret. "Every time ... -Sky Valley Journal Complaints abound for acne drug program Sep 14, 2006 Accutane, along with Amnesteem, Sotret and Claravis - the trio of generics approved in the past four years - are the only effective treatment for severe ... -Myrtle Beach Sun News Restrictions curb use of powerful acne drug Sep 12, 2006 Isotretinoin is sold as Accutane, from Roche Holding AG, and in three generic versions: Amnesteem from Mylan Laboratories Inc., Claravis from Barr ... -Pittsburgh Post Gazette Health Highlights: Aug. 29, 2006 Aug 29, 2006 ...the Associated Press reported. The drug is also sold in three generic versions -- Amnesteem, Claravis and Sotret. Nine out of 10 ... -Forbes Accutane rules create problems Aug 28, 2006 ...or take isotretinoin. Isotretinoin is sold as Accutane and as three generics: Amnesteem, Claravis and Sotret. The registry program ... -DetNews.com Accutane Restrictions Creating Problems 29 Aug 2006 ...take isotretinoin. Isotretinoin is sold as Accutane and in three generic versions: Amnesteem, Claravis and Sotret. The registry ... -Washington Post Acne drug registry irritates patients Aug 21, 2006 ...iPledge, which is jointly administered by companies that sell the drug as generic isotretinoin or under the brand names Accutane, Amnesteem, Claravis and Sotret ... -Chicago Sun-Times Barr Reports GAAP Earnings of $3.12 Per Share for Fiscal 2006 and ... Aug 15, 2006 ...of the Company's Dextro Combo and Didanosine products, which more than offset lower sales of certain existing products, including Mirtazapine, Claravis(TM) and ... -Finanzen.net Barr OK for new dose of acne drug Claravis May 12, 2006 WOODCLIFF LAKE, NJ, May 12 (UPI) -- Barr said Friday it has been OK'd to sell its acne drug Claravis -- a generic of Roche's Accutane -- in a 30 mg dose. ... - United Press International Barr gets FDA approval for new strength of acne drug May 15, 2006 Barr, which markets its line of isotretinoin capsules under the tradename Claravis, will launch the new dosage strength immediately. ... - Pharmaceutical Business Review Barr Receives Approval for Isotretinoin Capsules USP, 30 mg May 12, 2006 The Company will launch the product immediately under the tradename Claravis(TM). ... Claravis is indicated for the treatment of severe recalcitrant nodular acne. ... - PR Newswire Barr Receives Approval for Isotretinoin Capsules USP, 30 mg May 12, 2006 Represents Fourth Strength in Company's Claravis(TM) Product Line WOODCLIFF LAKE, NJ, May 12 /PRNewswire-FirstCall/ -- Barr Pharmaceuticals, Inc. ... - PR Newswire New Dosage for Barr Acne Drug Approved May 12, 2006 ...said Friday its subsidiary received Food & Drug Administration approval to make and market a 30 mg dosage of its Claravis capsules. ... - Houston Chronicle Barr unit gets regulatory nod for generic acne drug dosage May 12, 2006 The company said in a statement it will immediately launch the product, for the treatment of severe recalcitrant nodular acne, under the Claravis tradename. ... - Reuters Barr slides on patent woes May 12, 2006 ...as isotretinoin. Barr plans to launch the 30 mg formulation of the product immediately, under the brand name Claravis. The product ... - MarketWatch Accutane: Kills Acne, But Can It Kill You Too? Apr 18, 2006 Other names for accutane include Amnesteem, Claravis, Isotretinoin and Sotret. But wait, there is always some sort of "bad" that comes with the "good". ... - MediaSyndicate Accutane - Another Case of Too Little Too Late Apr 16, 2006 The drug is manufactured by Roche Pharmaceuticals and is also marketed under the generic names Amnesteem, Claravis, Isotretinoin, and Sotret. ... - Scoop.co.nz New warnings, risks, or restrictions for three skin drugs Mar 13, 2006 People using isotretinoin (Accutane, Amnesteem, Claravis, Sotret) to treat acne or other skin disorders literally need to get with the program--the iPLEDGE ... - Consumer Reports (subscription) FDA won't delay Accutane registry debut Feb 23, 2006 The drug, known formally as isotretinoin, is best known as Accutane but also is sold generically as Amnesteem, Claravis and Sotret. ... - USA Today FDA to set limits on acne drug, despite complaints Feb 24, 2006 The drug, best known as Accutane and also sold as Amnesteen, Sotret and Claravis, is considered a highly effective treatment for severe and disfiguring acne. ... - Contra Costa Times, Accutane Safety Program Improved Before Start Date Feb 24, 2006 Accutane is marketed in the United States by Hoffman-LaRoche Inc and is also available generically as Amnesteem (made by Genpharm Inc), Claravis (made by Barr ... - Medscape (subscription) Birth defects prompt limits on acne drug Mar 1, 2006 ...register online with iPledge, a new risk management program sponsored by the four companies that market isotretinoin, sold as Accutane, Claravis, Sotret and ... - San Jose Mercury News, FDA Considers Extending Accutane Deadline Feb 10, 2006 ...drug isotretinoin. Isotretinoin is sold as Accutane and in three generic versions: Amnesteem, Claravis and Sotret. But glitches ... - Forbes FDA might extend acne-drug deadline Feb 11, 2006 ...acne drug isotretinoin. Isotretinoin is sold as Accutane and in generic versions: Amnesteem, Claravis and Sotret. But glitches in ... - Orlando Sentinel, Accutane registry to begin next week Feb 21, 2006 The program focuses on the drug isotretinoin, best known as Accutane but also sold generically as Amnesteem, Claravis and Sotret. ... - Seattle Post Intelligencer Accutane program to prevent pregnancies among users to begin March ... Feb 26, 2006 ...get medication,� she said. Accutane is also sold under the brand names of Amnesteem, Claravis and Sotret. Even though the drug ... - Earthtimes.org National Briefs Feb 23, 2006 The drug, best known as Accutane and also sold as Amnesteen, Sotret and Claravis, is used by as many as 200,000 people a month, the FDA said. ... - Winston-Salem Journal, Barr Reports Second Quarter Fiscal 2006 GAAP Earnings of $0.88 Per ... Feb 7, 2006 2005 and sales of its Didanosine product that was launched in December 2004, which offset lower sales of certain other products, including Claravis(TM) and ... - MSN Money American Academy of Dermatology Looks to Delay Start of Accutane ... Feb 11, 2006 March 1. Isotretinoin is sold in the Accutane brand as well as in three generic versions: Amnesteem, Claravis and Sotret. However ... - All Headline News March of Dimes Applauds FDA Monitoring Program Feb 9, 2006 ...tests. Other brands of isotretinoin include Amnesteem, Claravis and Sotret. Other retinoids include Targretin and Vesanoid. The ... - PR Newswire, March of Dimes Applauds FDA Monitoring Program 09 Feb 2006 ...tests. Other brands of isotretinoin include Amnesteem, Claravis and Sotret. Other retinoids include Targretin and Vesanoid. The ... - PR Newswire Barr Reports Second Quarter Fiscal 2006 GAAP Earnings of $0.88 Per ... Feb 7, 2006 2005 and sales of its Didanosine product that was launched in December 2004, which offset lower sales of certain other products, including Claravis(TM) and ... - PR Newswire Acne medication can cause depression Jan 10, 2006 Roche, openly shares this information. Other brand names include Amnesteem, Claravis and Sotret. These drugs, synthetic derivatives ... - Newsday Doctors fear acne drug rules go too far Jan 30, 2006 These precautions were part of a program organized by the makers of Accutane and other brands of isotretinoin (Amnesteem, Claravis and Sotret) meant to prevent ... - Atlanta Journal Constitution (subscription) Twitching eye likely signals eyestrain, not diet problem Jan 16, 2006 Isotretinoin (Accutane, Claravis, others): This powerful drug is used for acne that scars or doesn’t respond to other treatments. ... - Fort Wayne Journal Gazette Brand Names/Synonyms: Claravis is also known by the following brand names and/or synonymsAberel; Accutane; Airol; Aknefug; Aknoten; All Trans Retinoic Acid; All Trans-Retinoic Acid; Amnesteem; Avita; Beta-Retinoic Acid; Claravis; Dermairol; Eudyna; Isotretinoin; Lsotretinoin; Panretin; Renova; Retin-A; Retin-a Micro; Retinoate; Retinoic Acid; Retinoic Acid, All Trans Isomer; Retionic Acid; Retisol-A; Solage; Sotret; Stieva-A; Stieva-a Forte; Trans-Retinoic Acid; Tretin M; Tretinoin; Tri-Luma; Vesanoid; Vitamin a Acid; Vitinoin; β-Retinoic Acid Drug Category: Claravis is categorized under the following by the FDA: Keratolytic Agents; Antineoplastic Agents; Cell Stimulants and Proliferants (84:16.00); ATC:D10AD01; ATC:D10AD04; ATC:D10BA01; ATC:L01XX14; ATC:L01XX22 Dosage Forms: CAPSULE; CREAM; GEL; LIQUID Absorption: 1-31% (topical); Interactions: Interactions for Tretinoin: Concomitant topical medications, medicated or abrasive soaps, shampoos, cleansers, cosmetics with a strong drying effect, products with high concentrations of alcohol, astringents, spices or lime, permanent wave solutions, electrolysis, hair depilatories or waxes, and products that may irritate the skin should be used with caution in patients being treated with RENOVA because they may increase irritation with RENOVA. RENOVA should not be administered if the patient is also taking drugs known to be photosensitizers (e.g., thiazides, tetracyclines, fluoroquinolones, phenothiazines, sulfonamides) because of the possibility of augmented phototoxicity. Chemical IUPAC Name: 3,7-dimethyl-9-(2,6,6-trimethyl-1-cyclohexenyl)-nona-2,4,6,8-tetraenoic acid : |
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