Novel New Drug Approvals in 2011: A Succinct Analysis of Drug Discovery Trends in the United States



  • D Samba Reddy


Thirty (30) new drugs have been approved by the FDA in 2011 for marketing in the United States. This list includes novel new drugs, known as new molecular entities (NMEs), biologics and new indications for drugs already approved. Eleven of the 30 NMEs were new drugs approved for orphan diseases, while twelve are considered first-in-class drugs with a unique new mechanism of action. During 2011, the FDA approved many unique and new drugs for chronic obstructive pulmonary disease, deep vein thrombosis, systemic lupus erythematosus (SLE), and epilepsy. In addition,  several new biologicals were approved in the past year for the treatment of macular degeneration, acute lymphoblastic leukemia, Hodgkin lymphoma, melanoma, chronic hepatitis C, and SLE. The introduction of 30 NMEs in 2011 underscores a robust success rate. It confirms that innovation is once again beginning to pay off. Analysis of drug approvals reveals a unique new trend in drug discovery in the face of stiff competition from generic products and declining revenues. In the existing climate of reduced pipeline for NMEs, the future and survival of big companies rests heavily on their unique niche products and biologics with relatively less competition from generic manufacturers. However, the competition for biosimilars is growing by the hour and therefore, crafting innovative generic biologicals is vital for generic biotech companies. Although the number of NMEs approved in the past 10 years has been declining, there is a substantial increase in R&D expenditure for drug discovery. Overall, the new drug approval list unveils unique and emerging trends in drug discovery especially in the current generics era. 


Download data is not yet available.


Metrics Loading ...


Biologics, blockbuster drugs, cancer drugs, clinical trials, new drugs, drug discovery, NMEs, pipeline syndrome, preclinical models.




How to Cite

Reddy DS. Novel New Drug Approvals in 2011: A Succinct Analysis of Drug Discovery Trends in the United States. Scopus Indexed [Internet]. 2012 Aug. 31 [cited 2024 Jun. 20];5(2):1661-5. Available from:



Review Articles


CDER (2012). 2011 Novel new drugs. CDER, FDA Brochure, January 2012, pp-1-14.

Hussar DA (2011). New therapeutic agents marketed in the first half of 2011: Part 1. Pharmacy Today, October, 86-93.

Mancano MA (2012a). New drugs of 2011. Part 1. Pharmacy Times, January issue.

Mancano MA (2012b). New drugs of 2011. Part 2. Pharmacy Times, February, pp-89-98.

Mullard A (2011). Reliability of new drug target claims called into question. Nature Rev Drug Discovery 10: 643-644.

Reddy DS and Woodward R (2004). Ganaxolone: A perspective overview. Drugs Future 29: 227-242.

Reddy DS (2010). Neurosteroids: Endogenous role in the human brain and therapeutic potentials. Progress in Brain Research 186: 113-137.

Scannell JW, Blanckley A, Helen Boldon H, and Warrington B (2012). Diagnosing the decline in pharmaceutical R&D efficiency. Nature Rev Drug Discovery 11: 191-200.

Swinney DC and Anthony J (2011). How were new medicines discovered? Nat Rev Drug Discovery 10: 507-519.

Wickenden A, Priest B, and Erdemli G (2012). Ion channel drug discovery: challenges and future directions. Future Med Chem 4:661-679.

Most read articles by the same author(s)

1 2 > >>