The U.S. Food and Drug Administration has granted Perrigo Co. final approval for hydrocodone bitartrate and homatropine methylbromide oral solution (syrup) 5 mg/1.5mg per 5 mL.
"This final approval is another example of Perrigo's ongoing commitment to developing high quality value alternatives in important treatment categories," Perrigo CEO John Hendrickson said. "The Rx team continues to leverage the company's development capabilities in order to deliver quality affordable health care products to our customers and consumers around the world."
The medication is intended for symptomatic cough relief in adults and children 6 and older. Sales for 12 months, ending in January, were approximately $16 million.
FDA grants Perrigo approval for cough relief medication
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