Apotex launches generic Atropine Sulfate Ophthalmic Solution

Apotex’s latest generic has received approval from the Food and Drug Administration and granted a Competitive Generic Therapy, CGT, designation.

Atropine Sulfate Ophthalmic Solution USP, 1% has also been given 180 days of CGT exclusivity, the Weston, Fla.-based company said.

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Indicated for the induction of cycloplegia and mydriasis, the product also is for the penalization of the healthy eye in the treatment of amblyopia.

“We are grateful to utilize the FDA’s CGT approval pathway as it enables us to provide first-to-market access to a low-cost, high-quality generic version of Atropine to Americans,” Peter Hardwick, president and CEO of Apotex said. “This launch highlights the agility of our manufacturing facilities and represents the critical role generics play in the U.S. health care system cost savings.”