Subject: FDA
Acella Pharmaceuticals, LLC, announces approval of generic to Vituz® Oral Solution
ATLANTA, July 27, 2017 /PRNewswire/ -- Acella Pharmaceuticals, LLC, a leading U.S. developer of specialty pharmaceuticals across several therapeutic categories, recently 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 approval continues Acella Pharmaceuticals' diverse portfolio of products and the commitment to provide effective and affordable health care solutions for its broad and growing 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. 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.
"Access to affordable and effective solutions for common illnesses is critical in our current healthcare environment," said Allen Fields, Acella's Senior VP, Clinical and Regulatory Affairs, Head of Research and Development. "Our team at Acella will continue to focus on product opportunities to positively impact the greatest healthcare needs in our society."
About Acella Pharmaceuticals, LLC
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. Acella specializes in identifying and bringing to market quality, affordable products to customers and patients. For additional information please contact Acella at 678-325-5189, or visit www.acellapharma.com.
An Abbreviated New Drug Application (ANDA) contains data which, when submitted to FDA's Center for Drug Evaluation and Research, Office of Generic Drugs, provides for the review and ultimate approval of a generic drug product. Once approved, an applicant may manufacture and market the generic drug product to provide a safe, effective, low-cost alternative to the American public.
A generic drug product is one that is comparable to an innovator drug product in dosage form, strength, route of administration, quality, performance characteristics and intended use. All approved products, both innovator and generic, are listed in FDA's Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book).
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 Acella Pharmaceuticals, LLC
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