ISTA Pharmaceuticals, Irvine, CA, Nov. 2 (DDMAC).The agency reviewed a journal advertisement for Vitrase (hyaluronidase HyaluronidaseAny one of a family of enzymes, also known as hyaluronate lyases or spreading factors, produced by mammals, reptiles, insects, and bacteria, which catalyze the breakdown of hyaluronic acid. injection; Ovine ovine pertaining to, characteristic of, or derived from sheep. ovine atopic dermatitis symmetrical erythema, alopecia, lichenification, excoriation on woolless areas; sporadic cases, recur each summer. , 200 USP Units/mL and Lyophilized, Ovine, 6200 USP Units) and concluded that the ad was false and misleading because it failed to reveal material facts and minimized the associated risks. According to the approved product labeling, Vitrase is indicated as an adjuvant to increase the absorption and dispersion of other injected drugs, hypo dermoclysis, and as an adjunct in subcutaneous urography urography /urog·ra·phy/ (u-rog´rah-fe) radiography of any part of the urinary tract. ascending urography , cystoscopic urography retrograde u. for improving resorption or radiopaque agents. DDMAC stated the ad failed to include any of the warnings associated with the use of the drug or the precautions regarding the incompatibility with furosemide furosemide /fu·ro·sem·ide/ (fu-ro´se-mid) a loop diuretic used in the treatment of edema and hypertension. fu·ro·se·mide n. A white to yellow crystalline powder used as a diuretic. , benzodiazepines and phenytoin phenytoin /phen·y·to·in/ (fen´i-toin?) an anticonvulsant used in the control of various kinds of epilepsy and of seizures associated with neurosurgery. phen·y·to·in n. . By omitting these risks, the journal ad misleadingly suggested that Vitrase is safer than has been demonstrated, the agency concluded. F-B: Doc. 13672W ISTA Pharmaceuticals's advertisement: Failed to include any of the warnings associated with the use of the drug [Vitrase]. Neglected to reveal material facts and minimized the associated risks. Failed to include contraindications with furosemide, benzodiazepines and phenytoin. |
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