Go-Ahead Given to Four Drugs for Cardio Conditions, Eczema, MS, and OPC
GSK, SkinMedica, Berlex, and Schering-Plough receive approvals.
The FDA approved GlaxoSmithKline's Coreg CR and SkinMedica’s Desonate, as well as expanded indications for Berlex’ Betaseron® and Schering-Plough’s Noxafil®.
GlaxoSmithKline's Coreg CR (carvedilol phosphate extended release capsules) has been authorized to treat hypertension, postmyocardial infarction left ventricular dysfunction, and mild-to-severe heart failure.
SkinMedica’s Desonate (desonide gel) 0.05% received the go ahead for the treatment of mild-to-moderate atopic dermatitis. It is a low-potency topical steroid formulated in a water- based Hydrogel vehicle developed by Dow Pharmaceutical Sciences. The product is approved for use in children older than three months and adults. The company predicts that it will be available to physicians in first quarter 2007.
Berlex’ Betaseron (interferon beta-1b) has been expanded to include patients with multiple sclerosis (MS) who have experienced a first clinical episode and have MRI features consistent with MS. This adds to Betaseron’s indication for relapsing forms of MS to reduce the frequency of clinical exacerbations. Betaseron is the only high-dose, high-frequency interferon beta indicated for patients at the earliest stage of MS, according to Berlex.
Schering-Plough’s Noxafil (posaconazole) Oral Suspension was approved for oropharyngeal candidiasis, including infections refractory to itraconazole and/or fluconazole. Noxafil is a triazole antifungal agent. This follows the approval of the drug for prophylaxis of invasive aspergillus and candida infections in patients 13 years and older who are at high risk of developing these infections due to being severely immunocompromised.