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FDA OKs Par's Miralax Generic
Posted on 2006-05-30 14:39:00
Par Pharmaceutical Companies, Inc. today announced that its wholly-owned subsidiary, Kali Laboratories, Inc., has received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application for polyethylene glycol 3350 NF powder for oral solution, 17 grams/scoopful. Polyethylene glycol 3350 NF powder for oral solution is the generic version of Miralax(TM), which is marketed by Braintree Laboratories, Inc. and is indicated for the treatment of occasional constipation. Total annual U.S. sales of polyethylene glycol 3350 NF powder for oral solution exceed $150 million. Par will begin shipping the product immediately.
Par Pharmaceutical Companies, Inc. develops, manufactures and markets generic drugs and innovative branded pharmaceuticals for specialty markets. In 2005, Par received approval for and introduced the appetite stimulant Megace ES, its first branded pharmaceutical product. Par's generic products division is committed to providing high-quality pharmaceuticals that are affordable and accessible to patients.
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