• WHAT IS 505(b)(2)?
  • SERVICES
    • Identify Products
      • Strategic Drug Assessment
      • Pre-IND / Integrated Development Plan
      • Product Ideation
    • Develop Products
      • Nonclinical Testing
      • CMC Development
      • Clinical Studies, Phases I-IV
      • Market Assessment
    • Regulatory Strategy
      • Complex Generics
      • FDA Meetings & Submissions
      • Additional Strategies
  • 505(b)(2) BLOG
  • ABOUT
    • The Company
      • Our History
      • Our Experience
      • Leadership Team
    • Resources
      • Success Stories
      • White Papers
      • Speaking Events & Webinars
    • The Latest
      • Press and News
      • Events
  • CAREERS
  • CONTACT US
  • WHAT IS 505(b)(2)?
  • SERVICES
    • Identify Products
      • Strategic Drug Assessment
      • Pre-IND / Integrated Development Plan
      • Product Ideation
    • Develop Products
      • Nonclinical Testing
      • CMC Development
      • Clinical Studies, Phases I-IV
      • Market Assessment
    • Regulatory Strategy
      • Complex Generics
      • FDA Meetings & Submissions
      • Additional Strategies
  • 505(b)(2) BLOG
  • ABOUT
    • The Company
      • Our History
      • Our Experience
      • Leadership Team
    • Resources
      • Success Stories
      • White Papers
      • Speaking Events & Webinars
    • The Latest
      • Press and News
      • Events
  • CAREERS
  • CONTACT US

FDA Stops DESI Unapproved Rx Narcotics

  • Posted by: Ken Phelps
  • Published on: April 1, 2009

Yesterday, 3/31/09, FDA sent warning letters to nine pharmaceutical companies  to stop manufacturing 14 unapproved narcotic drugs.  These drugs are unapproved because they were made without NDA or ANDA approvals, falling under the category of DESI or grandfathered drugs.

Warning letters were sent to the following companies (I have listed the affected drug products for each company – note that the same 2 products are sold by 2 companies):

 Glenmark Generics Inc. Morphine Sulfate Tablets, 15 mg & 30 mg
Morphine Sulfate Solution Immediate Release Concentrate, 20 mg/ml
Morphine Sulfate Solution Immediate Release Oral Solution, 20mg/5ml
 Lannett Company, Inc. Morphine Sulfate Solution Immediate Release 20mg/ml
Hydromorphone HCl Tablets, 2mg and 4mg
 Lehigh Valley Technologies Inc. Morphine Sulfate Tablets, 15 mg & 30 mg;
Morphine Sulfate Solution Concentrate, 20 mg/ml
 Mallinckrodt Inc. Pharmaceuticals Group Morphine Sulfate Concentrate Oral Solution 20mg/ml
 Xanodyne Pharmaceuticals Inc. Roxanol Oral Solution, 20 mg/ml
Roxicodone Tablets, 5 mg
 Physicians Total Care, Inc. Morphine Sulfate Immediate Release Tablets, 30 mg;
Hydromorphone Tablets, 2 mg;
Hydromorphone Hydrochloride Tablets 4 mg
 Roxane Laboratories, Inc. Hydromorphone Hydrochloride Tablets, 2 mg & 4 mg
 Boehringer Ingelheim Roxane Inc. Roxanol Oral Solution, 20 mg/ml;
Roxicodone Tablets, 5 mg
 Cody Laboratories, Inc. Morphine Sulfate Solution Immediate Release 20mg/ml

Camargo is engaged in a number of conversions of DESI to 505(b)(2) NDA’s.  Clients are concerned that, once approved, the FDA would allow the unapproved competition to remain on the market.  We believe actions such as this confirm that the FDA, once an NDA product is available, will take action.  This latest action is a result of a program instituted in January 2007 ( summary here).

Need Help With A Project?

Contact the 505(b)(2) experts at Camargo Pharma about the challenge you are facing with your 505(b)(2) project.

Click Here To Get Help

Need Help?

Contact the 505(b)(2) experts at Camargo Pharma today.

Click Here

Recent Posts
  • The Shutdown From Camargo’s Perspective
  • Scope of Orphan Drug Exclusivity – How Broad is Broad?
  • Market Assessment: Is Your Product Going To Make It On The Market?
Categories
  • 505(b)(2) Development
  • Camargo Counsel
  • Case Study
  • Clinical Studies, Phases I-IV
  • CMC
  • Combination Products
  • Commercialization
  • DESI Drug
  • Device
  • Nonclinical Testing
  • Orphan Drug
  • Prodrug
  • Product Selection and Planning
  • Regulatory Strategy & Submissions
  • Services
  • Therapeutic Areas
  • What Went Wrong?
TRUSTED RESOURCES
  • Center Watch Trial Listing
  • Drugs @ FDA
  • Electronic Orange Book
  • FDA Dockets Home Page
  • US Patent & Trademark Access

camargo pharma

Camargo Pharmaceutical Services provides comprehensive drug development services specialized for the 505(b)(2) approval pathway and analogous European processes.

Headquarters:
9825 Kenwood Road, Suite 203
Cincinnati, OH 45242

Durham Office
2505 Meridian Parkway, Suite 150
Durham, NC 27713

Phone: (513) 561-3329
Toll free: (888) 451-5708
Fax (513) 561-3367

LATEST FROM THE BLOG
  • The Shutdown From Camargo’s Perspective
  • Scope of Orphan Drug Exclusivity – How Broad is Broad?
  • Market Assessment: Is Your Product Going To Make It On The Market?
  • “Breakthrough” the Barriers: Breakthrough Therapy Designation for 505(b)(2)
  • On the “Fast Track”: Fast Track Designations for Your 505(b)(2) Drug Development Program
ADDITIONAL LINKS
  • Home
  • In The News
  • Services
  • 505(b)(2) Blog
  • About Us
  • Camargo Careers
  • Contact Us
© 2019 Camargo | Privacy Policy