FDA Approves Perrigo’s Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution

Perrigo Company has received final approval from the U.S. Food and Drug Administration for hydrocodone bitartrate and homatropine methylbromide oral solution (syrup), 5 mg/1.5 mg per 5 mL.

Hydrocodone bitartrate and homatropine methylbromide oral solution (syrup), 5 mg/1.5 mg per 5 mL is indicated for the symptomatic relief of cough in adults and children 6 years of age and older. Annual sales for the 12 months ending January 2017 were approximately $16 million.  

Perrigo CEO John T. Hendrickson stated, "This final approval is another example of Perrigo's ongoing commitment to developing high quality value alternatives in important treatment categories. The Rx team continues to leverage the Company's development capabilities in order to deliver Quality Affordable Healthcare Products® to our customers and consumers around the world."