On March 16, 2010 FDA ordered Glenmark Generics and Konec to cease manufacturing and distribution of nitroglycerin tablets. These actions are part of the FDA program to remove unapproved products from the market. In this case, Pfizer makes the approved product, so these removed products can be thought of as unauthorized generics.
Archive for March, 2010
FDA Removes Unapproved Nitroglycerin Tablets
Published March 18th, 2010 in News Commentary. 0 CommentsFDA’s Determination of Vyvanse as NME Upheld
Published March 12th, 2010 in 505(b)(2) Issues and News Commentary. 0 CommentsOn March 4, 2010 the U.S. District Court for the District of Columbia agreed that FDA was within its rights to grant Shire’s Vyvanse (lisdexamfetamine dimesylate) NME status and thus, 5-years exclusivity. New Rivers Pharmaceuticals (NRP) was the original sponsor of the lisdexamfetamine NDA. During the 2/23/2007 approval, FDA determined that the API was a new molecular [...]
FDA’s DAARP is now DAAP, DPAP is now DPARP
Published March 10th, 2010 in News Commentary. 0 CommentsEffective March 15th, the FDA’s Division of Anesthesia, Analgesia, and Rheumatology Products is being reorganized. This reorganization is part of some other reassignments announced yesterday (3/09/2010) by the FDA. The “R” part – Rheumatology, will move to the Division of Pulmonary and Allergy Products, which will be renamed the Division of Pulmonary, Allergy, and Rheumatology [...]
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 (clinical [...]
Do Not Neglect Your Third-Party Drug Substance Manufacturer
Published March 2nd, 2010 in Uncategorized. 0 CommentsAnother 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 deficiencies which [...]
Proposed FDA rule would make Sponsors more responsible for data integrity – way more responsible
Published March 2nd, 2010 in Uncategorized. 0 CommentsOn 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) [...]
505(b)(2) Approvals
Published March 26th, 2010 in 505(b)(2) Issues and News Commentary. 0 CommentsFor those who missed it, I have recently posted 505(b)(2) approvals 2004 – to February 2010. I am working on pre-2004 approvals and will add the post as time permits. I have seen various postings and articles on the number of 505(b)(2) approvals. The numbers do not always agree. Why don’t they agree? Many people [...]