July 8, 2002
Morton Grove Pharmaceuticals, Inc., (MGP) of Morton Grove, Illinois, announced today the Food & Drug Administration (FDA) approved for manufacturing and marketing the company's ANDA for Prednisolone Sodium Phosphate Oral Solution, 5 mg (base)/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 (base)/5 mL marketed by Celltech Pharmaceuticals, Inc.
The FDA ruled that since MGP was the first applicant to submit a complete ANDA with a Paragraph IV Certification, the company is granted 180 days of marketing exclusivity as provided under the Drug Price Competition and Patent Restoration Act of 1994 (Hatch-Waxman Amendment).
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, gastrointestinal diseases; allergic states and nervous system disorders (acute exacerbations of multiple sclerosis).
Brian Tambi, Chairman, President & CEO of MGP, commented that "Prednisolone Sodium Phosphate Oral Solution is the fourth major drug approved for MGP by the FDA in the past two 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. These three oral suspensions are the dosage form of choice for the older and pediatric patient populations in which we specialize. MGP is the leading pharmaceutical company in these healthcare market segments. In the next few months, we expect a number of further FDA approvals. Thus, 2002 and the next three (3) years are promising to be great years for MGP. All of us at MGP are very pleased."
Morton Grove Pharmaceuticals, Inc., is a specialty pharmaceutical company that develops, manufactures and markets a broad line of prescription generic oral liquid, topical, sterile inhalation and intra-nasal prescription drugs. MGP is a private company owned by Brian Tambi and William Blair Capital Partners of Chicago, Illinois.
SOURCE Morton Grove Pharmaceuticals, Inc.
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