RANBAXY RECEIVES PARAGRAPH IV CERTIFICATION
Gurgaon, India, Sept. 19, 2013 – Ranbaxy Laboratories Inc. (RLI), a wholly owned subsidiary of Ranbaxy Laboratories Limited, today announced that the company has received a Paragraph IV Certification Notice of filing from Watson Laboratories Inc. of an Abbreviated New Drug Application (“ANDA”) to the U.S. Food and Drug Administration (“FDA”) for a generic version of Absorica™ (isotretinoin capsules), a product that is licensed from Cipher Pharmaceuticals Inc. (TSX: DND) (”Cipher”) of Mississauga, Ontario. read all a thttp://www.pharmalive.com/watson-files-anda-for-ranbaxys-absorica
Isotretinoin, INN, /ˌaɪsoʊtrɨˈtɪnoʊ.ɨn/, first marketed as Accutane by Hoffmann-La Roche, is a medication primarily to curecystic acne. Rarely, it is also used to prevent certain skin cancers (squamous-cell carcinoma), and can be used in the treatment of brain, pancreatic and other cancers. It is used to treat harlequin-type ichthyosis, a usually lethal skin disease, and lamellar ichthyosis. It is a retinoid, meaning it is related to vitamin A, and is found in small quantities naturally in the body.
Isotretinoin is currently the standard of care for treatment of severe, scarring cystic acne. The most common adverse effects are a transient worsening of acne (lasting 2–3 weeks), dry lips (cheilitis), dry skin, and a propensity to sunburn easily. Other side effects are rare but do include: muscle aches and pains (myalgias), headaches. Isotretinoin is known to cause birth defectsdue to in utero exposure because of the molecule’s close resemblance to retinoic acid, a natural vitamin A derivative which controls normal embryonic development.
In the United States a special procedure is required to obtain the pharmaceutical. In most other countries a consent form is required which explains these risks. Women taking isotretinoin must not get pregnant during, and for 1 month after isotretinoin therapy. Sexual abstinence, or effective contraception is mandatory during this period. Barrier methods by themselves (such as condoms) are not considered adequate due to the unacceptable failure rates of approximately 3%. Women who fall pregnant whilst on isotretinoin therapy are generally counselled to have a termination. Isotretionin has no effect on male reproduction.
There is little evidence in the medical literature linking isotretinoin use with depression and suicide. Despite this, there exists a popular misconception amongst the public that isotretinoin use commonly causes depression.
In 2009, Roche decided to remove Accutane from the US market after juries had awarded millions of dollars in damages to former Accutane users over inflammatory bowel disease claims. Other common brands are Roaccutane (Hoffman-La Roche, known as Accutane in the United States before July 2009), Amnesteem (Mylan), Claravis (Barr), Isotroin (Cipla) or Sotret(Ranbaxy).