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FDA Grants Approval of Acella Generic to Vituz Oral Solution.

M2 PHARMA-July 28, 2017-FDA Grants Approval of Acella Generic to Vituz Oral Solution


- US-based specialty pharmaceuticals developer Acella Pharmaceuticals, LLC has received approval from the Food and Drug Administration's for its abbreviated new drug application for a hydrocodone bitartrate and chlorpheniramine maleate oral solution, 5 mg/4 mg per 5 mL, as a bioequivalent product to VITUZ Oral Solution, the company said.

This approval continues Acella Pharmaceuticals' diverse portfolio of products and the commitment to provide effective and affordable health care solutions for its base of customers.

This combination medicine is indicated for relief of cough and symptoms associated with upper respiratory allergies or a common cold in adults 18 years of age and older.

The incidence of the common cold exceeds one billion cases in the United States each year. A majority of the population is likely to have more colds than any other type of illness.

Acella develops, markets, sells and distributes a broad portfolio of non-branded pharmaceutical and other products in the areas of dermatology, women's health, pediatrics and other applications.

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Publication:M2 Pharma
Date:Jul 28, 2017
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