Biopharmaceutics Inc. announces FDA orphan drug status approval.BELLPORT, N.Y.--(BUSINESS WIRE)--July 13, 1995--Biopharmaceutics Inc. (AMEX AMEX See: American Stock Exchange :BPH BPH abbr. benign prostatic hyperplasia BPH Benign prostatic hypertrophy, a very common noncancerous cause of prostatic enlargement in older men. ) announced today that the Food and Drug Administration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) has granted the company's application for Orphan Drug Status for use as adjuvant therapy in the treatment of primary brain tumors, utilizing Mitolactol (DBD), the company's cancer drug which already holds Orphan Drug Status for the treatment of cervical cancer. DBD has successfully completed Phase III testing for both cervical cancer and brain cancer and the company now has patent-like protection for DBD through the Orphan Drug Status. The company's Consultant, Dr. Stewart Ehrreich, is currently assembling and organizing the materials necessary to file a New Drug Application for DBD with the FDA. The company anticipates filing the New Drug Application (NDA (Non Disclosure Agreement) An agreement signed between two parties that have to disclose confidential information to each other in order to do business. In general, the NDA states why the information is being divulged and stipulates that it cannot be used for any ) in the first quarter of 1996 and believes it will take between 9 and 15 months to receive approval of the NDA from the FDA after the filing. In granting Biopharm's application, the FDA expanded the coverage originally requested by Biopharm from Malignant Astrocytoma astrocytoma /as·tro·cy·to·ma/ (as?tro-si-to´mah) a tumor composed of astrocytes; the most common type of primary brain tumor and also found throughout the central nervous system, classified on the basis of histology or in order of (Brain Cancer) Grades III and IV. CONTACT: Biopharmaceutics Inc. Stuart Fine, 516/286-5800 |
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