FDA approves Perrigo’s hydrocodone bitartrate and homatropine methylbromide

WASHINGTON — The U.S. Food and Drug Administration approved Perrigo’s 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, according to Perrigo. 

“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,” said Perrigo CEO John T. Hendrickson.