Astellas Pharma won FDA approval for their sNDA for the use of Mycamine (micafungin sodium) for injection in the treatment of patients with candidemia, acute disseminated candidiasis, candida peritonitis and abscesses. Mycamine was approved in 2005 for the treatment of patients with esophageal candidiasis and is the only echinocandin approved for the prophylaxis of candida infections in patients undergoing hematopoietic stem cell transplantation.
Alpharma announced the availability of the Flector patch (diclofenac epolamine topical patch) 1.3% in the US. The adhesive patch delivers medication directly to the site of pain, offering a safe and effective alternative to widely used nonsteroidal anti-inflammatory drugs that are taken orally. The targeted delivery of Flector patch through the skin results in minimal systemic absorption of diclofenac.
MiddleBrook Pharmaceuticals received FDA approval of its NDA for once-daily Moxatag tablets 775 mg (amoxicillin extended-release tablets) for the treatment of adults and pediatric patients 12 years and older with pharyngitis and/or tonsillitis secondary to Streptococcus pyogenes (commonly referred to as strep throat).