Par Pharmaceutical unit granted final FDA approval for generic product for constipation

By Lisa Kerner

Erie, Pa., May 30 - The Food and Drug Administration has granted final approval to Kali Laboratories, Inc., a wholly owned subsidiary of Par Pharmaceutical Cos., Inc. for its abbreviated New Drug Application for polyethylene glycol 3350 NF powder for oral solution, 17 grams/scoopful, the generic version of Miralax for the treatment of occasional constipation.

Par said it will begin shipping the product immediately.

Total annual U.S. sales of polyethylene glycol 3350 NF powder for oral solution exceed $150 million, according to a company news release.

Spring Valley, N.Y.-based Par develops, manufactures and markets generic drugs and branded pharmaceuticals for specialty markets.

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