Apr 3 2006, 2:14 PM EST
News source: Business Wire
Connetics Corporation (NASDAQ:CNCT), a specialty pharmaceutical company that develops and commercializes dermatology products, today announced the filing of a Citizen Petition with the U.S. Food and Drug Administration (FDA) to request that any generic products that reference Soriatane(R) (acitretin) meet several criteria in addition to rigorous bioequivalency testing prior to approval. The criteria outlined in the Citizen Petition will ensure that patients are adequately protected from generic versions of acitretin that might not be comparable in safety and efficacy to the branded product.Subtle differences between Soriatane and a generic acitretin that change the extent or route of metabolism, absorption, distribution or elimination of acitretin can significantly increase the risks associated with the well-known conversion of acitretin to the potent teratogen, etretinate, and therefore reduce the effectiveness of current safeguards to manage these risks. The Citizen Petition outlines several ways in which the FDA can confirm that a generic acitretin is in every way the same as Soriatane, in order to ensure that the labeling instructions and other safeguards put in place for Soriatane are sufficient to give the same level of protection to patients who receive generic acitretin.
"In the Citizen Petition, Connetics has outlined certain tests we strongly believe the FDA should require of any company to ensure its generic product is the same as Soriatane with regard to important attributes that are related to product safety," said Thomas G. Wiggans, Chairman and Chief Executive Officer of Connetics. "Typically, a few basic bioequivalency tests are required for an amended new drug application (ANDA). But the overall pharmacologic equivalence of a generic takes on greater significance for a product with the chemical complexities of acitretin, which directly impact the way it can be most safely used."
About Soriatane
Soriatane is a once-daily oral retinoid medication that is supplied in 10 mg and 25 mg capsules for the treatment of severe psoriasis in adults, including plaque, erythrodermic, pustular, guttate and palmar-plantar. Soriatane is the only oral once-a-day medication approved for both initial and maintenance treatment for severe psoriasis in adults. Acitretin is a metabolite of the teratogen etretinate, and for women should only be considered for those with severe psoriasis unresponsive to other therapies or whose clinical condition contraindicates the use of other treatments. Soriatane is contraindicated in females who are pregnant or who intend to become pregnant during therapy or at any time for at least three years following discontinuation of therapy.
About Connetics
Connetics Corporation is a specialty pharmaceutical company focused on the development and commercialization of innovative therapeutics for the dermatology market. Connetics has branded its proprietary foam drug delivery vehicle VersaFoam(R). The Company's marketed products are OLUX(R) (clobetasol propionate) Foam, 0.05%, Luxiq(R) (betamethasone valerate) Foam, 0.12%, Soriatane(R) (acitretin) capsules and Evoclin(R) (clindamycin) Foam, 1%. Connetics is developing Velac(R) (a combination of 1% clindamycin and 0.025% tretinoin) Gel, for treating acne; Desilux(TM) (desonide) VersaFoam-EF, 0.05%, a low-potency topical steroid formulated to treat atopic dermatitis; Primolux(TM) (clobetasol propionate) VersaFoam-EF, 0.05%, a super high-potency topical steroid formulation to treat atopic dermatitis and plaque psoriasis; and Extina(R) (ketoconazole) VersaFoam-HF, 2%, to treat seborrheic dermatitis. Connetics' product formulations are designed to improve the management of dermatological diseases and provide significant product differentiation. In Connetics' marketed products, these formulations have earned wide acceptance by both physicians and patients due to their clinical effectiveness, high
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