Hawthorn Pharmaceuticals, Inc., a subsidiary of Pernix Therapeutics Holdings, Inc. (PTX) Thursday said it has received approval from the U.S. Food and Drug Administration, or FDA, for VITUZ Oral Solution.
VITUZ solution is indicated for the relief of cough and symptoms associated with upper respiratory allergies or a common cold in adults 18 years of age and older.
The company also said that its subsidiary, Cypress Pharmaceuticals, Inc., has been granted final approval by the FDA for Mefenamic Acid Capsules USP, 250 mg, a generic version of Ponstel Capsules, 250 mg, indicated for relief of mild-to-moderate pain in patients treated of primary dysmenorrhea.
"VITUZ broadens our cough and cold product line and is our first NDA approved by the FDA, since the acquisition of Hawthorn and Cypress, " said Cooper Collins, President, CEO.
Launch of the new treatment option for cough and cold symptoms is expected prior to the fall of 2012. Mefenamic Acid Capsules are expected to launch in the second quarter.
by RTT Staff Writer
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