Acella Pharmaceuticals, LLC, announces approval of generic to Vituz oral solution.
Acella Pharmaceuticals, LLC, a U.S. developer of specialty pharmaceuticals across several therapeutic categories, announced the Food and Drug Administration’s approval of the company’s abbreviated new drug application (ANDA) for a Hydrocodone Bitartrate and Chlorpheniramine Maleate Oral Solution 5 mg/4 mg per 5 mL as a bioequivalent product to Vituz Oral Solution.
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. Colds can occur at any time of the year, but they are most common in the winter or rainy seasons.1-3
“Acella continues to actualize new product launch opportunities that align with our strategic mission to provide optimal healthcare support for the medical community and their patient population,” said Harold A. Deas, Jr., CEO for Acella Pharmaceuticals.
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References:
1 Turner RB. The common cold. In: Goldman L, Schafer AI, eds. Goldman’s Cecil Medicine. 24th ed. Philadelphia, PA: Saunders Elsevier; 2011:chap 369.
2 Fashner J, Ericson K, Werner S. Treatment of the common cold in children and adults. Am Fam Physician. 2012;86(2):153-159.
3 Singh M, Das RR. Zinc for the common cold. Cochrane Database of Systematic Reviews. 2011, Issue 2. Art. No.: CD001364.
(Source: PR Newswire)
