Amnesteem, Clavaris and Sotret are generic versions of Isotretinoin, the popular acne-medication sold by Hoffman La Roche as Accutane. Like Accutane, all three of these generics have been linked to serious side effects such as depression, aggressive or violent behavior, thoughts of suicide, attempts at suicide, tingling sensation of the skin, sun sensitivity, back, joint, and muscle pain, fever and other signs of infection, painful swallowing and pancreatic disease.
Amnesteem was originally approved on November 8, 2002 for the treatment of severe nodular acne. The medication guide for the drug, which is manufactured by GenPharm, warns patients that "Mental problems and suicide" are possible serious side effects (possible depression side effects such as; sadness, anxiety, empty mood, and feelings of worthlessness). Amnesteem is no longer listed on GenPharm's product list.
Clavaris and Sotret are other forms of generic Accutane. Clavaris was originally approved in April of 2003 and is manufactured by Barr Laboratories. The drug is currently still on the market. Sotret was approved in December of 2002 and is manufactured by Ranbaxy Pharmaceuticals, Inc.
In order for a manufacturing firm to market and sell a generic drug, the FDA requires the following:
- There must be an FDA approved brand name drug that is the reference for the proposed generic.
- The generic must have the same active ingredient or ingredients and the same labeled strength as this reference product. It must have the same dosage form-tablet (patches and liquids are examples of dosage forms). It must be administered the same way as well.
- The manufacturer must show the generic drug as "bioequivalent" to the brand name drug.
- The generic drug's labeling must be essentially the same as that of the approved drug.
- The firm must fully document the generic drug's chemistry, manufacturing steps, and quality control measures. Each step of the process must be detailed for the FDA to review.
- The firm must assure the FDA that the raw materials and finished product meet USP specifications, if these have been set. The USP, or U.S. Pharmacopoeia, is the non-profit, scientific body chartered by Congress to set standards for drug purity in this country.
- The firm must show that its generic drug maintains stability as labeled before it can be sold. Once on the market, the firm must continue to monitor the drug's stability. The firm must show that the container and its closure system won't interact with the drug. Firms making sterile drugs must submit sterility assurance data showing microbiologic integrity of these products.
- The firm must provide a full description of the facilities it uses to manufacture, process, test, package, label and control the drug. It must certify that it complies with federal regulations about current good manufacturing practices and undergo FDA inspection of the manufacturing facility to assure compliance.
- Before FDA approves a generic drug, it usually conducts an inspection at the proposed manufacturing site to make sure the firm is capable of meeting its application commitments and to ensure the firm can manufacture the product consistently.
If you or a loved one have taken Amnesteem, Clavaris or Sotret and have experienced any side effects, contact us immediately at 800-966-4999 and see why our law firm has recovered over $100 million on behalf of our clients.
