Hawthorn Pharmaceuticals, Inc. to market FDA-approved Zamicet™ (hydrocodone bitartrate and acetaminophen oral solution)
Madison, Miss. – September 3, 2008 – Hawthorn Pharmaceuticals, Inc. announces the nationwide launch of Zamicet™ (hydrocodone bitartrate and acetaminophen oral solution). The oral solution, recently approved by the Food and Drug Administration (FDA), is indicated for moderate to moderately severe pain with dosing to two years of age. Zamicet™ Oral Solution contains 10 mg of hydrocodone bitartrate and 325 mg of acetaminophen per 15 mL.
“We are very optimistic about the opportunities that Zamicet™ gives Hawthorn,” said Chris Smith, EVP of Sales and Marketing. “Zamicet™ will offer patients a safe dose of acetaminophen with an effective dose of hydrocodone in a liquid form. Many patients require a pain medication that is in a liquid form. Zamicet™ should help fill this need and benefit both adult and children.” Hawthorn Pharmaceuticals, Inc. acquired the exclusive marketing, sales and distribution rights to Zamicet™ Oral Solution from Pharmaceutical Associates, Inc.
Important Safety Information:
Zamicet™ (hydrocodone bitartrate and acetaminophen oral solution) is indicated for the relief of moderate to moderately severe pain. The most common side effects associated with hydrocodone/acetaminophen are abdominal pain, dizziness, drowsiness, light-headedness, nausea, shortness of breath, unusual tiredness, and vomiting. Zamicet™ contains hydrocodone which, in high doses or certain patients, may cause dose-related respiratory depression, elevated intracranial pressure, or irregular breathing. Infants may have increased sensitivity to these respiratory depressant effects. As with any narcotic, special caution should be used when prescribing hydrocodone to elderly or debilitated patients, as well as individuals with impaired hepatic or renal function, hypothyroidism, Addison’s disease, prostatic hypertrophy, or urethral stricture. Caution should also be exercised with patients who are likely to take other acetaminophen-containing medications, allergy medicines, antidepressant medicines, or other medicines that cause central nervous system depression, including alcohol. Hydrocodone, like all narcotics, may impair mental and/or physical abilities required for the performance of potentially hazardous tasks such as driving a car or operating machinery. Such tasks should be avoided while taking this product. Zamicet™ should not be taken if a patient is allergic to hydrocodone or acetaminophen. Patient should check with physician if they are pregnant or are nursing. Hydrocodone can produce drug dependence and has the potential for being abused.
About Hawthorn Pharmaceuticals
Hawthorn Pharmaceuticals, Inc., founded in 1998, is a specialty pharmaceutical company that develops and markets prescription pharmaceutical products to multiple physician specialties. Hawthorn has a diverse product line marketed by its nationwide sales force. Hawthorn has an aggressive product development pipeline including multiple new drug applications (NDAs) in various stages of development. Hawthorn expects additional submissions with the Food and Drug Administration (FDA) to be approved in 2008. Additionally, Hawthorn has successfully signed several in-licensing agreements with multinational companies in the past several years and continues to utilize strategic alliances as part of its overall pharmaceutical pipeline.
