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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Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
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A new pilot aims to take Brazil closer to ‘digital transformation.’
The European Medicines Agency says that a regulatory reliance pilot that it is supporting to speed up assessments of post-approval changes appears to be accelerating evaluation timelines in non-EU countries.
The UK regulator’s draft guideline on the use of external control arms based on real-world data reflects concepts similar to those outlined by the US Food and Drug Administration.
The Pink Sheet's list of EU centralized approvals of new active substances has been updated to include two new products, one of which is Vyjuvek, Krystal Biotech's advanced therapy for treating dystrophic epidermolysis bullosa.
