|Name/Company||Approval Dates and Comments|
The US FDA approved a new oral contraceptive (OC) in September 2010 to raise folate levels in women who choose an OC for birth control. The addition of levomefolate calcium raises folate levels for the purpose of reducing the risk of a neural tube defect in a pregnancy conceived while taking Beyaz™ or shortly after discontinuation. This novel formulation combines the hormone ingredients in the birth control pill Yaz® (drospirenone 3 mg / ethinyl estradiol 20 mcg) with 451 mcg levomefolate calcium. The approval of Beyaz™ is based on Yaz®, which contains the same doses of estrogen and progestin, and is approved for three indications: prevention of pregnancy; treatment of symptoms of premenstrual dysphoric disorder in women who choose an OC for contraception; and treatment of moderate acne vulgaris in women =14 years of age, but only if the patient prefers an OC for birth control.
The US FDA approved a generic version of imiquimod 5% cream in September 2010 for the topical treatment of actinic keratoses on the face or scalp, superficial basal cell carcinoma, and external genital and perianal warts in patients =12 years of age (innovator brand Aldara® 5% cream, Graceway Pharmaceuticals).
In September 2010, the US FDA issued requirements for gadolinium-based contrast agents (GBCAs) to carry new warnings on their labels to highlight the risk of nephrogenic systemic fibrosis (NSF), a rare and potentially fatal condition, if the drug is administered to certain patients with kidney disease. The symptoms of NSF can include scaling, hardening and tightening of the skin, red or dark patches on the skin, and stiffness. GBCAs are intravenous agents used with magnetic resonance imaging or magnetic resonance angiography to aid in the detection of abnormalities of body organs, blood vessels, and other tissues. An FDA safety review of the most widely used GBCAs determined that Magnevist® (Bayer HealthCare), Omniscan™ (GE Healthcare), and Optimark™ (Covidien) are associated with a greater risk than other GBCAs for NSF in some patients with kidney disease. More specifically, the new warnings for these three GBCAs will be described as inappropriate for use among patients with acute kidney injury or chronic severe kidney disease. Prior to administration, all GBCA labels will emphasize the need to screen patients to detect these types of kidney dysfunction.
In September 2010, the US FDA’s Anti-Infective Drugs Advisory Committee voted unanimously in favor of approving ceftaroline fosamil (Forest Laboratories Inc.) for the treatment of community acquired bacterial pneumonia and complicated skin and skin structure infections. Ceftaroline is a novel, broad-spectrum injectable cephalosporin antibiotic with activity against both gram-positive bacteria (including methicillin-resistant Staphylococcus aureus [MRSA] and Streptococcus pneumoniae) and common gram-negative pathogens.