I attended the Annual GPhA meeting this past week. This event is attended by the CEO’s and other top brass of most of the major generic pharmaceutical companies. This year was highlighted by a presentation from the FDA Commissioner, Dr. Margaret Hamburg. In her remarks, Dr. Hamburg admitted to a need for FDA to step up [...]
Archive for February, 2010
Can and Should ANDA Labeling Differ from the RLD?
Published February 11th, 2010 in ANDA's and News Commentary. 0 CommentsIn the past two months, two appellate courts, the Fifth Circuit and the Eighth Circuit have handed down decisions which essentially state that generic pharmaceutical companies can be sued in state courts for failure-to-warn regarding serious side effects, where the generic companies had conformed their labeling to that of the current Reference Listed Drug.
For a [...]
Roche’s Actemra Approved For RA After Year’s Delay
Published February 11th, 2010 in 505(b)(2) Issues and News Commentary. 0 CommentsJohn Jenkins, Office of New Drugs Director, remarked on the low rate (30 percent) of firstcycle approvals for standard review applications (‘The Pink Sheet,’ Dec. 7, 2008). He attributed the low approval rate in part to the submission of applications that require amendments, often because the original submissions were incomplete or incorrect. A recent example [...]
News on the Biosimilar Front
Published February 8th, 2010 in News Commentary and Uncategorized. 0 CommentsTuesday, February 2nd, Teva Pharmaceuticals announced that the FDA will review its new biologic license application (BLA) to sell a biotechnology medicine, Neutroval, to boost white blood cells, which is “similar” to Amgen Inc’s Neupogen®(filgrastim). The new product is already marketed as TevaGrastim in Europe. There is a regulatory pathway for approving generic versions of [...]
Pediatric Assessments in Drug Development: timing in Europe vs. US
Published February 5th, 2010 in 505(b)(2) Issues, How to: and Uncategorized. 0 CommentsAs we have noted in this blog on several occasions, under the Pediatric Research Equity Act (PREA) (21 U.S.C. 355c), all new drug applications for a new active ingredient, new indication, new dosage form, new dosing regimen, or new route of administration are required to contain an assessment of the safety and effectiveness of the product [...]
505(b)(2) Food Revealed
Published February 4th, 2010 in News Commentary and Uncategorized. 0 CommentsTalking about teaching old dogs new tricks! For over 40 years we’ve been spilling ketchup from those nasty packets. Today, Heinz revealed a vast improvement:
We can only wish all 505(b)(2) drug developments could impact so many lives!
Once Daily Trazodone Approved
Published February 4th, 2010 in 505(b)(2) Issues and News Commentary. 0 CommentsYesterday, 2/3/10, FDA approved under 505(b)(2) Canadian-based Labopharm’s once-daily version of trazodone HCl for the treatment of depression (as of this writing, this approval is not posted on the FDA web site). The initial PDUFA date was July 18, 2009 but this was missed because FDA found issues when inspecting the API manufacturing facility – [...]
In a time where there are going to be government spending caps and cuts, the Administration is proposing a 23% increase in FDA’s 2011 budget (see pages 19-21). Some of this additional money is proposed to come from new fees on food facilities ($220 million) and generic drug makers ($38 million in user application fees [...]
Spending on DTC Ads
Published February 23rd, 2010 in News Commentary and Uncategorized. 0 CommentsAt GPhA last week, one of the CEO’s on an industry panel said that big pharma spent more on DTC (direct-to-consumer) advertising than on R&D. Clearly, generic companies don’t like this promotional activity, but I was skeptical of the facts. A quick Google of DTC costs brought an article in the New England Journal of Medicine with [...]