ROCKVILLE, Md., Sept. 16, 2009--The FDA has posted on its
website warning letters it sent to Allergan, Inc. and Bioniche
Pharma. For Allergan, the agency said in its letter that a consumer
website and a launch display timeline for eyelash drug
Latisse are misleading "because they omit and minimize risks
associated with Latisse." Regarding Bioniche Pharma, the
FDA reviewed two internet web pages for Sotradecol on the
Bioniche website and the AngioDynamics website. The FDA said,
"The web pages are false or misleading because they present
efficacy claims for Sotradecol but fail to communicate any
information about the risks associated with the product."
Mitosol Mitosol (mitomycin) is an antimetabolite indicated as an adjunct to ab externo glaucoma surgery.
Sklice Sklice (ivermectin) Lotion is a pediculicide indicated for the topical treatment of head lice infestations in patients 6 months of age and older.
Jentadueto Jentadueto (linagliptin and metformin) is a dipeptidyl peptidase-4 (DPP-4) inhibitor and biguanide combination product indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Kalydeco Kalydeco (ivacaftor) is a cystic fibrosis transmembrane conductance regulator (CFTR) potentiator indicated for the treatment of cystic fibrosis (CF) in patients age 6 years and older who have a G551D mutation in the CFTR gene.
Voraxaze Voraxaze (glucarpidase) is a carboxypeptidase enzyme indicated for the treatment of toxic plasma methotrexate levels in patients with delayed methotrexate clearance due to impaired renal function.
Erivedge Erivedge (vismodegib) is a hedgehog pathway inhibitor for the treatment of patients with advanced basal cell carcinoma (BCC).
Including products under brand names Cardinal Health, Medical Specialties, VHA, Triad, Triad Plus, North Safety, Total Resources, Atwater Carey, Lee Medical ...
