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Manager, Package Engineering - GSK-USA- Research Triangle Park, North Carolina

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• develop business case justifications, which should include robust market research data, complete equipment engineering evaluation, and financial justification.
• specify processes relating to packaging materials, molds, tooling, components and functional testing
• provide NPS documentation support and team leadership with the completion of the CIDD, PIDD, Pack Brochures, and graphic logo and pack designs.
• provide critical documentation including Package Component Specifications, General Specifications, and PAO/PRFs.
• provide technical/project management support to all USA Manufacturing locations (UMO, Bristol, Zebulon)
• improve production and procurement efficiencies through development and implementation of cost effective packaging technologies

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Reports of hearing loss due to Erectile Dysfunction Drugs Levitra, Viagra and Cialis:

Submitted by sailajabyrisetty on Sat, 01/26/2008 - 23:40.

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fda
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FDA has received reports of sudden decreased or loss of hearing after using the Erectile Dysfunction drugs such as, Viagra, Levitra, and Cialis. Revatio, a Sildenafil product marketed for pulmonary arterial hypertension, is also included in the list. In some cases, the sudden hearing loss was accompanied by tinnitus and dizziness. So, FDA asked manufacturers to add a precaution about potential hearing loss to the products labeling.

This request is based on 29 post-marketing reports of sudden hearing loss. In most cases, hearing loss involved one ear and occurred within hours to 3 days of the last dose. Hearing loss appears to be persistent in about 2 out of 3 cases. As per FDA request, the labeling for Viagra, Levitra and Cialis was revised to address this new safety information.
FDA is working on revising label for ‘Revatio’ too.