Lupin receives USFDA approval for Phenylephrine and Ketorolac Intraocular Solution

Lupin Limited (Lupin) announced that it has received approval for its Phenylephrine and Ketorolac Intraocular Solution, 1%/0.3%, from the United States Food and Drug Administration (U.S. FDA).

Lupin’s Phenylephrine and Ketorolac Intraocular Solution, 1%/0.3%, is the generic version of Omidria Intraocular Solution, 1%/0.3%, Omeros Corporation (Omeros). It is indicated for:

• maintaining pupil size by preventing intraoperative miosis

• reducing postoperative ocular pain

Phenylephrine and Ketorolac Intraocular Solution, 1%/0.3%, is added to an ocular irrigating solution used during cataract surgery or intraocular lens replacement.

Phenylephrine and Ketorolac Intraocular Solution, 1%/0.3%, had annual sales of approximately USD 42.8 million in the US (IQVIA MAT March 2019).