The 2012 PDUFA User Fees have been announced in the Federal Register. In summary, the fees are: Applications: Full – requiring clinical data (e.g., Phase 2 or 3): $1,841,500 Not requiring clinical data : 920,750 Supplements requiring clinical data : 920,750 Establishment fee: $520,100 Product: $98,970 For those doing the math, the cost [...]
Archive for the 'News Commentary' Category
Whew! Supreme Court rules generic labels must track RLD
Published June 24th, 2011 in News Commentary. 0 CommentsA lot of generic companies are breathing easier today. As we discussed in this blog before, two district courts ruled that generic companies must comply with state laws and add warnings to the label even if it differs from that of the brand product (the Reference Listed Drug – RLD). The cases went to the [...]
Yesterday (08Jun11) The Wall Street Journal reported (subscription may be required) that Pfizer will cut an additional $1 Billion – mostly in administrative costs. These cuts come after cuts to sales and R&D. What’s driving all of these cuts is two-fold: loss of sales of their products to generics and failure to obtain approval for [...]
Why generic companies might like 505(b)(2)
Published June 2nd, 2011 in ANDA's and News Commentary. 0 CommentsHow would you like to spend a couple of hundred thousands of dollars (or equivalent local currency) and countless months getting FDA approval and patent expiration and then face 14 competitors? What’s the ROI for that? June 1, 2011 Donepezil Hydrochloride Tablets, Matrix Laboratories Ltd., Approval Donepezil Hydrochloride Tablets, Cipla Ltd., Approval Donepezil Hydrochloride Tablets, Wockhardt [...]
KV’s Makena® Part 1: 505(b)(1) or 505(b)2)?
Published May 18th, 2011 in 505(b)(2) Process and News Commentary. 0 CommentsIn a previous posting, I provided background on KV’s Makena (17α-hydroprogesterone caproate injection aka 17P). The development and regulatory history contains many lessons. In this posting I’d like to examine the choice of regulatory route. Makena was approved under 505(b)(2) as seen from the approval letter (at this writing the approval documents are not posted [...]
Revised Safety Reporting for BE/BA Studies Effective March 28, 2011
Published March 23rd, 2011 in News Commentary. 0 CommentsOn September 29, 2010 FDA published a Final Rule revising the requirements for safety reporting for INDs and other BE/BA studies. At the same time FDA issued an accompanying draft guidance to assist in interpreting the new rule. The Final Rule, revising 21 CFR §§ 312.32, 312.64 and 320.31, becomes effective March 28, 2011. The [...]
What is the Pediatric Drug Development Approach for Rare Diseases and Orphan Drugs?
Published March 23rd, 2011 in 505(b)(2) Issues and News Commentary. 0 CommentsAs part of the PDUFA V reauthorization discussions, the FDA and industry are talking about better approaches to rare disease drug development and orphan drugs. Public interests and Congress have mandated that FDA develop new guidances on the required studies needed for NDA approval. In these discussions, participants refer to the “pediatric drug development approach” [...]
Approvals of ANDAs slows
Published February 21st, 2011 in ANDA's, Events and News Commentary. 0 CommentsI attended the 2011 Generic Pharmaceutical Association (GPhA) meeting last week. There was lots of useful information from several speakers. One area in particular stood out to me — the approvals of ANDAs are slowing and there is a growing awareness that the root cause is not just the Office of Generic Drugs (OGD). As [...]
Contrave® Rejection: The Long and the (Too) Short of it
Published February 21st, 2011 in 505(b)(2) Issues and News Commentary. 0 CommentsOn February 1st Orexigen(R) Therapeutics, Inc. and Takeda Pharmaceutical Company Limited (Takeda) announced that the FDA issued a complete response letter dated January 31, 2011 regarding the New Drug Application for Contrave® (naltrexone HCl/bupropion HCl) extended-release tablets for the treatment of obesity, including weight loss and maintenance of weight loss (http://ir.orexigen.com/phoenix.zhtml?c=207034&p=irol-newsArticle&ID=1522207&highlight=). In the letter, FDA [...]
Stability Changes coming to ANDAs
Published October 4th, 2011 in ANDA's and News Commentary. 0 CommentsThis post comes from D.C. where I am attending the GPhA Fall Technical Conference. We just completed a presentation by FDA’s Glen Smith. He detailed the proposed new stability requirements for ANDA drug products. It is essentially the adoption of ICH Q1A. For readers of this blog, we know that 505(b(2) NDA’s must have 12 months [...]