Apotex Corp. Announces Approval and Launch of Atropine Sulfate Ophthalmic Solution USP, 1% in the United States

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Dec 07, 2021, 08:00 ET

WESTON, Fla., Dec. 7, 2021 /PRNewswire/ - Apotex Corp. has received approval and was granted a Competitive Generic Therapy (CGT) designation for its generic version of Atropine Sulfate Ophthalmic Solution USP, 1% by the U.S. Food and Drug Administration (FDA). As the first approved application, Apotex has been granted 180 days of CGT exclusivity.

Atropine is indicated for the induction of Cycloplegia and Mydriasis, and 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," said Peter Hardwick, President and CEO of Apotex Corp. "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."

According to the Association for Accessible Medicines U.S. Generic & Biosimilar Medicines Savings Report 2021, the U.S. health care system has saved nearly $2.4 trillion in the last 10 years due to the availability of affordable generics.

About Apotex Corp.

Apotex Corp. is a US based company, headquartered in Weston, Florida. Along with other global affiliates of Apotex, Apotex Corp. are leaders in generic pharmaceuticals and is committed to supplying patients with a broad portfolio of high-quality, affordable medicines covering all major therapeutic areas.

SOURCE Apotex Corp.