Drug makers and biotech companies have numerous projects under development in 2011. However, chances for a new round of big blockbusters to replace those that are expiring are little, according to researchers.
The rate at which FDA is approving new drugs continues to be sluggish as there were only 17 approvals in 2010, as compared to 26 approvals in 2008 and 25 in 2009. Out of the seventeen, thirteen were specialty drugs; 2 were for contraceptives and 1 for an ophthalmic anti-allergy.
Applications for new drugs dropped from 160 in 2009 to 125 in early 2010. The lists of drugs in the pipeline for 2011 are as under:
Gralise: FDA has approved DepoMed Inc. (Nasdaq: DEPO), Gralise as a once-daily treatment for persistent pain condition caused by nerve damage after a shingles infection.
Gattex: NPS Pharmaceuticals Inc (Nasdaq: NPSP), Gattex which will reduce the need for intravenous feeding in two-thirds of patients with short-bowel syndrome. The drug is expected to be available for sale in second-half of 2011.
Viibryd tablets (vilazodone hydrochloride): FDA approved Viibryd (vilazodone), Trovis Pharmaceuticals LLC product on January 21, 2011 for the treatment of major depression disorder.
Lupus, GlaxoSmithKline Plc (NYSE: GSK), product is a human monoclonal antibody drug. BLyS-specific inhibitor is the first in a new class of drugs. The approval is expected in March, 2011. If approved, it will be the first drug in more than 50 years for the treatment of lupus.
Natroba (spinosad), a product of ParaPRO LLC, indicated for the treatment of head lice infestations for children and adults.
GE Healthcare's DaTscan (ioflupane I 123 injection) is a radio-pharmaceutical for diagnostic, which use single-photon emission computed tomography to assist in the evaluation of adult patients for Parkinsonian syndromes.
Tasocitinib a Pfizer Inc. (NYSE: PFE), product for psoriasis and rheumatoid arthritis (RA).
Abstral (fentanyl), an Orexo AB product, indicated for the management of breakthrough pain in cancer patients.