Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

"NDA DAY" PLANNED FOR NOVEL DOSAGE FORM OF PREVIOUSLY APPROVED

Executive Summary

"NDA DAY" PLANNED FOR NOVEL DOSAGE FORM OF PREVIOUSLY APPROVED ingredient, FDA Pilot Drug Review Division consumer safety officer James Hannan told a May 14 conference in Washington, D.C. Reporting on the continued use of "NDA Days" as an overview to bring together the final stages of application review, Hannan told the "1990 NDA Pipeline Conference" that his division is beginning to schedule the next of the sponsor/agency meetings for July. FDA typically sets a firm date for an "NDA Day" about three weeks prior to the event. Alza's fentanyl patch product is a logical candidate for the July "NDA Day" based on the status of that application, Hannan's description of "novel dosage" form to be reviewed, and the purview of the Pilot Drug Division at FDA. As a narcotic analgesic, the active ingredient is being reviewed by the analgesic drug review group. The patch dosage form has been pending at FDA since the end of 1987. Alza says that the company has been informed that TTS-fentanyl will be the subject of an "NDA Day." FDA's Pilot Drug Division hopes to be able to devote more attention to final labeling review at the future "NDA Days." That has been an area that has led to delays following "NDA Day" agreements on the bulk of the approval issues. For the upcoming, July meeting, FDA hopes to have a final package insert complete by the end of the "NDA Day." TTS-fentanyl will be marketed by Janssen Pharmaceutica. The J&J subsidiary has marketed the ingredient as an injectable analgesic used in conjunction with anesthetics. Alza will have the right to co-market the product to oncologists. Alza has maintained in the past that the active ingredient shows great potential as an analgesic. When the company first described the compound to analysts several years ago, an Alza exec said fentanyl is "more than 100 times as powerful in the containment of pain as morphine." The ingredient has not been available for analgesia because it cannot be delivered orally. TTS-fentanyl is being developed for "patients experiencing acute postoperative pain or the severe, long-term pain often associated with cancer." The dosage form can deliver the ingredient for up to 72 hours. Alza has worked closely with the Pilot Drug Division at FDA. It is one of two companies that has reportedly discussed management information systems with the division for tracking NDA documents. The other company that has consulted with FDA on that effort is Wyeth-Ayerst. The "NDA Day" review process is being tested outside the Pilot Drug Division. The Oncology & Pulmonary Drug Division in the Office of Drug Evaluation I has reportedly experimented with the NDA concept.

You may also be interested in...



Part D Discount Liability Coming Into Focus: CMS Releases Drug Cost Data

Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011

FDA Skin Infections Guidance Spurs Debate On Endpoint Relevance

FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials

Shire Hopes To Sow Future Deals With $50M Venture Fund

Specialty drug maker Shire has quietly begun scouting deals with a brand-new $50 million venture fund, the latest of several in-house investment arms to launch with their parent company's pipelines, not profits, as the measure of their worth

UsernamePublicRestriction

Register

LL029263

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel