Drug Development Comments - Focused on 505(b)(2)
Exalgo, hydromorphone extended release tablet was approved March 1, 2010. I waited a couple of days to see if it was approved under 505(b)(1) or 505(b)(2). At this writing, we don’t know.
We have previously detailed in this blog the regulatory approval saga for this drug. When we last heard, FDA had told CombinatoRx/Covidien/Alza [...]
Another example of the importance CMC was reported in January. Warner Chilcott plc received a complete response letter from the FDA. The “low dose” oral contraceptive NDA was the file in question. The FDA inspection of the third-party drug substance manufacturing facility and control testing laboratory used to support the application reported outstanding [...]
On February 19th, 2010, FDA published a proposed rule in the Federal Register to revise 21 CFR §§ 16, 58, 71, 101, 171, 190, 312, 511, 571 and 812 to require Sponsors of the various impacted regulatory applications to file a report with FDA providing specific information when someone “has or may have (emphasis added) [...]
Tuesday, 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 [...]
As 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 [...]
Talking 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!
Another example of the importance CMC was reported in the news today. Warner Chilcott plc received a complete response letter from the FDA. Their “low dose” oral contraceptive NDA was the file in question. The FDA inspection of the third-party drug substance manufacturing facility and control testing laboratory used to support the application [...]
Although morphine sulfate oral solution has been used for many years in pain management, it had never been approved by the FDA. As part of their ongoing unapproved drugs initiative, the FDA announced on March 30, 2009 that it was taking enforcement action against Roxane and 6 other firms selling morphine sulfate oral solution. [...]
FDA is trying to remove unapproved new drugs from the market. This past year the FDA approved URL’s colchicine. Previously, FDA announced it was taking action against unapproved colchicine on the market. We have commented on these actions in this blog.
A recent article in Kaiser Health News questions whether the approval of these [...]
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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 [...]