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FDA approves erythromycin ophthalmic ointment USP 1 g

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LAKE FOREST, Ill. — The U.S. Food and Drug Administration has approved the release of erythromycin ophthalmic ointment USP 1 g as a supplement to erythromycin ophthalmic ointment USP 3.5 g, according to a press release from Akorn, the manufacturer of the compound.

"Recent market shortages have made this an attractive product which is complimentary to the other ophthalmic ointments Akorn currently sells," Akorn CEO Raj Rai, said in the release. "This approval gives us access to both the sizes of erythromycin ophthalmic ointment and positions us to compete effectively in all channels through which the product is sold."

The company has already begun shipping the new antibiotic agent to customers, the release said.

Erythromycin ophthalmic ointment is the only product approved for prophylaxis of ophthalmia neonatorum from Neisseria gonorrhoeae or Chlamydia trachomatis in the U.S.

The FDA approved Akorn's supplemental abbreviated new drug application for erythromycin ophthalmic ointment USP 3.5 g in April.