Adrenocortical Steroids

FDA gives nod to generic prednisolone oral solution

Published in Drug Week, September 6th, 2002

Morton Grove Pharmaceuticals, Inc., (MGP) of Morton Grove, Illinois, announced the U.s. Food & Drug Administration (FDA) approved for manufacturing and marketing the company's ANDA for prednisolone sodium phosphate oral solution, 5 mg /5 mL.

The FDA concluded that MGP's drug is safe and effective for use as recommended in the labeling and bioequivalent and, therefore, therapeutically equivalent to the brand drug Pediapred Oral Solution, 5 mg /5 mL marketed by Celltech Pharmaceuticals, Inc.

Prednisolone sodium phosphate oral solution is an adrenocortical steroid drug indicated for the treatment of conditions associated with a broad spectrum of...

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Source: Drug Week (2002-09-06)

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