BAY LABS' HALOPERIDOL ORAL SOLUTION ANDA PROSPECTIVELY APPROVED
• By The Pink Sheet
BAY LABS' HALOPERIDOL ORAL SOLUTION ANDA PROSPECTIVELY APPROVED by FDA on March 7. The actual approval is delayed until the patent for McNeil's Haldol expires April 15. Bay Labs is the first company to obtain a generic approval for the tranquilizer. The haloperidol approval also represents the first time that Bay Labs has been first among generic mfrs. to receive an ANDA approval for a post-1962 drug. Bay Labs said it plans to begin shipping the drug the date the Haldol patent expires. The generic drug is indicated for use in treatment of psychotic disorders, Tourette's Syndrome, and hyperactive children. The ANDA approval is for a 2 mg/ml solution. Haldol is available in tablet, concentrate, and injectable formulations. McNeil also has an NDA pending for the injectable dosage for prolonged neuroleptic therapy. FDA's Psychopharmacologic Drugs Advisory Cmte. recommended approval of the indication last October ("The Pink Sheet" Oct. 14, p. 6). McNeil has already prepared for future tablet dosage forms of generic haloperidol. In an effort to bolster brand recognition, the company announced in October that it was redesigning Haldol tablets by cutting an "H" shape into the tablet.
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