Hawthorn Pharmaceuticals, Inc. Receives FDA Approval On Granisol™ Oral Solution

Main Category: Cancer / Oncology
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 17 Mar 2008 - 1:00 PST

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Hawthorn Pharmaceuticals, Inc. announced the US Food and Drug Administration (FDA) approval of the company's Granisol™ (granisetron HCl) Oral Solution. Granisol™ is an oral solution for the prevention of nausea and vomiting associated with cancer therapy. Granisol™ is the AA-rated equivalent of Roche's Kytril® Oral Solution.

"According to the National Cancer Institute, oral mucositis occurs in almost all patients receiving radiation for head and neck malignancies, in more than 75% of bone marrow transplant recipients, and in nearly 40% of patients receiving chemotherapy," said Chris Smith, Vice President of Sales. "We feel this product will fill an important need in helping to prevent nausea and vomiting associated with chemotherapy or radiation for cancer therapy patients who may have difficulty swallowing tablets."

Granisol™ Oral Solution is available through all the national drug wholesalers as well as multiple other distribution channels and will begin shipping immediately. Granisol™ Oral Solution is available by prescription only in the United States.

Important Safety Information

Granisol™ (granisetron HCl) is indicated for the prevention of nausea and vomiting associated with initial and repeat courses of emetogenic cancer therapy, including high-dose cisplatin and with radiation, including total body irradiation and fractionated abdominal radiation. The most frequently reported clinical adverse events occurring in >5% of patients receiving Granisol™ were headache, constipation, asthenia, and diarrhea. The use of Granisol™ in patients following abdominal surgery or in patients with chemotherapy induced nausea and vomiting may mask progressive ileus and/or gastric distention. For full prescribing information, visit http://www.hawthornrx.com/PIs/GranisolPI.pdf.

About Hawthorn Pharmaceuticals

Hawthorn Pharmaceuticals, Inc., founded in 1998, is a specialty pharmaceutical company that develops and markets prescription pharmaceutical products to multiple physician specialties. Hawthorn has a diverse product line marketed by its nationwide sales force. Hawthorn has an aggressive product development pipeline including multiple new drug applications (NDAs) in various stages of development. Hawthorn expects additional submissions with the Food and Drug Administration (FDA) to be approved in the first half of 2008. Additionally, Hawthorn has successfully signed several in-licensing agreements with multinational companies in the past several years and continues to utilize strategic alliances as part of its overall pharmaceutical pipeline.

Hawthorn Pharmaceuticals