Roche said the FDA has approved a supplemental New Drug Application to market Tamiflu (oseltamivir phosphate) capsules in 30 mg and 45 mg doses. The lower dose capsules provide an alternative for the treatment and prevention of influenza types A and B in patients one year and older. Since the capsules have a longer shelf life than the liquid suspension formulation (five years vs. 24 months), they also offer an improved option for government pandemic stockpiling. Tamiflu will continue to be available in a 75 mg capsule for adults as well as liquid suspension formulation for children. The 30 mg and 45 mg capsules will be available in pharmacies nationwide and for government stockpiling for the 2007-2008 flu season. To date, Roche has filled orders from the US federal government and states for 43.7 million Tamiflu treatment courses.
Bradley Pharmaceuticals announced that its Doak Dermatologics subsidiary recently launched two new product line extensions from its Kerol and Rosula brand portfolios. Kerol topical suspension (50% Urea), a potent keratolytic in a vehicle containing lactic acid & salicylic acid, is an addition to the line of Kerol Redi-Cloths keratolytic moisturizers. Kerol topical suspension is indicated for the treatment of hyperkeratotic conditions such as dry, rough skin, dermatitis, psoriasis, xerosis, ichthyosis, eczema, keratosis pilaris, keratosis palmaris, keratoderma, corns and calluses. Rosula clarifying wash (sodium sulfacetamide 10% and sulfur 4%) is the fourth product launched under the Rosula brand. The new Rosula clarifying wash formulation combines 10% sodium sulfacetamide and 4% sulfur in a urea vehicle and is indicated for the treatment of acne vulgaris, acne rosacea and seborrrheic dermatitis. Bradley launched the Rosula brand in 2003 with Rosula Aqueous Gel which was followed by Rosula aqueous cleanser and Rosula NS medicated pads.
Fosteum (capsules), designed to safely address the underlying disease processes of osteopenia and osteoporosis, is now available nationwide from Primus Pharmaceuticals.