September 6, 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 disorders and diseases of many organ systems such as endocrine, rheumatic, hermatologic disorders; neoplastic, respiratory, ophthalmic, dermatological,and gastrointestinal diseases, allergic states, and nervous system disorders (acute exacerbations of multiple sclerosis).
Brian Tambi, chairman, president, and CEO of MGP, said, "Prednisolone sodium phosphate oral solution is the fourth major drug approved for MGP by the FDA in the past 2 months. It is a huge opportunity for us and, along with phenytoin, just launched, and carbamazepine, about to be launched, MGP has built a strong portfolio of therapeutically important and widely prescribed oral suspension drugs for major disease states. Prednisolone sodium phosphate oral solution will be launched immediately."
This article was prepared by Drug Week editors from staff and other
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