On the new drug side we have had user fees since 1992. The Prescription Drug User Fee Act (PDUFA) has been renewed many times. The Act provides that FDA will adhere to certain goals in return for fees levied on industry. The pharmaceutical industry has benefited from PDUFA in greater certainty of the timeframe for [...]
Archive for August, 2010
Will We Have Generic User Fees? Public Meeting To Be Held.
Published August 23rd, 2010 in ANDA's and Events. 0 CommentsLannett’s Morphine Sulfate Oral Solution: 505(b)(2) or 505j?
Published August 23rd, 2010 in 505(b)(2) Issues, ANDA's and News Commentary. 0 CommentsLannett Co., Inc. and its subsidiary Cody Laboratories manufacture Morphine Sulfate Immediate Release Concentrated Oral Solution 20mg/mL. Readers will remember that the various manufacturers of morphine solution were the first to receive FDA enforcement letters based on the Agency’s Unapproved Drugs Initiative. Roxane Laboratories filed an NDA for its product which was approved January 25, [...]
Today, Marwood Group Advisory Services broadcast an e-mail giving its thoughts on the approval of Momenta Pharmaceutical’s generic of Lovenox®. This is a very nice write up of the regulatory history, including the summary of the Citizen Petition filed by Sanofi- Aventis challenging such approval, but it contains a glaring error. Upon approval and an [...]
FDA announced the new PDUFA user fees for fiscal year 2011 (starts October 1, 2010). The fee for a full application containing clinical data is $1,542,000. For a supplement or an NDA not requiring clinical data, the fee is $771,000. A clinical study is generally Phase 2 or Phase 3, so a 505(b)(2) approved based [...]
Experience that shows electronic filing of NDA’s, IND’s and ANDA’s helps speed up the review and approval of these applications. Perhaps because of the software cost and extensive training needed some companies still submit paper applications. Effective today, August 1, 2010, the address to submit the paper ANDA is: Office of Generic Drugs (HFD—600) Center [...]
Failed 505(b)(2)?: Vivus™ Qnexa
Published August 31st, 2010 in 505(b)(2) Issues and News Commentary. 0 CommentsI am often asked about 505(b)(2) drug development failures. After all, 505(b)(2) is a regulatory pathway that is chosen because it is lower cost and has lower risk than a 505(b)(1). The lower risk is attributable to the reliance on the known safety and efficacy of the reference drug product. Indeed, one of the strategies [...]