Combination Drugs: Adding Up the Opportunities - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

Combination Drugs: Adding Up the Opportunities
Fixed-dose combination drug therapies give rise to innovation in solid-dosage formulations and manufacturing.


Pharmaceutical Technology
Volume 36, Issue 10, pp. 40-47, 127

References

1. Code of Federal Regulations, Title 21, Food and Drugs (Government Printing Office, Washington, DC), Chapter I, Part 3, Subchapter A, Sec. 3.2 (e).

2. FDA, FY 2011 Performance Report to Congress for the Office of Combination Products (Rockville, MD).

3. FDA, "Frequently Asked Questions About Combination Products" (Rockville, MD), http://www.fda.gov/CombinationProducts/AboutCombinationProducts/ucm101496.htm, accessed Sept. 15, 2012.

4. Code of Federal Regulations, Title 21, Food and Drugs (Government Printing Office, Washington, DC) Chapter 1, Part 300, Subpart B, Sec. 300.50.

5. FDA, FDA Approved Drugs, Drugs@FDA, accessed Sept. 15, 2012.

6. A. Kane, D. Monterroza, and C. Salazar, "Unlocking the Power of New Softgel Technology for Multiple Formulations" Webcast, Pharm. Technol., http://www.PharmTech.com/apiformulations/, accessed Sept. 15, 2012.

7. FDA, Label for Janumet XR (Rockville, MD, 2012).

8. FDA, Label for Juvisync (Rockville, MD, 2011).

9. FDA, Label for Qsymia (Rockville, MD, 2012).

10. FDA, Label for Jalyn (Rockville, MD, 2010).

11. FDA,Label for Suboxone Sublingual Film (Rockville, MD, 2010).


ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
|Monthly
| Weekly

Survey
FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
Reducing drug shortages
70%
Breakthrough designations
4%
Protecting the supply chain
17%
Expedited reviews of drug submissions
2%
More stakeholder involvement
7%
View Results
Eric Langerr Outsourcing Outlook Eric LangerRelationship-building at Top of Mind for Clients
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerRisk Reduction Top Driver for Biopharmaceutical Raw Material Development
Jill Wechsler Regulatory Watch Jill Wechsler Changes and Challenges for Generic Drugs
Faiz Kermaini Industry Insider Faiz KermainiNo Signs of a Slowdown in Mergers
CMOs and the Track-and-Trace Race: Are You Engaged Yet?
Ebola Outbreak Raises Ethical Issues
Better Comms Means a Fitter Future for Pharma, Part 2: Realizing the Benefits of Unified Communications
Better Comms Means a Fitter Future for Pharma, Part 1: Challenges and Changes
Sandoz Wins Biosimilar Filing Race
Source: Pharmaceutical Technology,
Click here