2010 FDA Approved Drugs as of 28th June,2010

Following are the FDA Approved Drugs as of 28th june, 2010.No need to remember
brand name of the drug.Remember only Drug name.Under each drug, the first point is
indication(use) and the 2nd point is its mechanism of action of that drug. some already
known drugs may approved for their new indication,combination with other drug or new
type of formulation. So first you read drugs which are very new to market then just once
go through already existed drugs
(imiquimod)
 for the topical treatment of clinically typical visible or palpable actinic keratoses of the
full face or balding scalp in immunocompetent adults.
 which belongs to a class of drugs called immune response modifiers (IRM's).
it is known that imiquimod activates immune cells through the toll-like receptor 7,
commonly involved in pathogen recognition, on the cell surface.

(denosumab)

 postmenopausal women with osteoporosis at high risk for fracture

 is a fully human monoclonal antibody that binds to RANKL, a transmembrane or soluble
protein essential for the formation, function, and survival of osteoclasts, the cells
responsible for bone resorption. Prolia prevents RANKL from activating its receptor,
RANK, on the surface of osteoclasts and their precursors. Prevention of the
RANKL/RANK interaction inhibits osteoclast formation, function, and survival, thereby
decreasing bone resorption and increasing bone mass and strength in both cortical and
trabecular bone.

(pancrelipase
 exocrine pancreatic insufficiency
 Pancrelipase contains multiple enzyme classes, including porcine-derived lipases,
proteases, and amylases. The pancreatic enzymes in PANCREAZE catalyze the
hydrolysis of fats to monoglyceride, glycerol and free fatty acids, proteins into peptides
and amino acids, and starches into dextrins and short chain sugars such as maltose and
maltriose in the duodenum and proximal small intestine, thereby acting like digestive
enzymes physiologically secreted by the pancreas
(Liraglutide
 type 2 diabetes mellitus
 an analog of human GLP-1 and acts as a GLP-1 receptor agonist. Liraglutide increases
intracellular cyclic AMP (cAMP) leading to insulin release in the presence of elevated
glucose concentrations.

(velaglucerase alfa
 Gaucher disease
 is a human glucocerebrosidase product.Gaucher disease, caused by deficiency of the
enzyme glucocerebrosidase, results in accumulation of a toxic glycolipid substrate, called
glucocerebroside. Velaglucerase alfa supplements or replaces beta-glucocerebrosidase,
the enzyme that catalyzes the hydrolysis of glucocerebroside, reducing the amount of
accumulated glucocerebroside and correcting the pathophysiology of Gaucher disease.

N.Ramana Chary,M.S(Pharma),NIPER,Mohali. Page 1

 2010 FDA Approved Drugs as of 28th June,2010

Everolimus
 organ rejection following kidney transplant
 binds to the immunophilin FK Binding Protein-12 (FKBP-12) to generate an
immunosuppressive complex that binds to and inhibits the activation of the mammalian
Target of Rapamycin (mTOR), a key regulatory kinase. Inhibition of mTOR activation
results in the inhibition of T lymphocyte activation and proliferation associated with
antigen and cytokine (IL-2, IL-4, and IL-15) stimulation and the inhibition of antibody
production
tocilizumab
 rheumatoid arthritis
 is a recombinant humanized anti-human interleukin 6 (IL-6) receptor monoclonal
antibody of the immunoglobulin IgG1 kappa subclass. It binds specifically to both
soluble and membrane-bound IL-6 receptors (sIL-6R and mIL-6R), and has been shown
to inhibit IL-6-mediated signaling through these receptors.
onabotulinumtoxinA
 upper limb spasticity
 is a sterile, vacuum-dried purified botulinum toxin type A, produced from fermentation of
Hall strain Clostridium botulinum type A. Botox blocks neuromuscular transmission by
binding to acceptor sites on motor or sympathetic nerve terminals, entering the nerve
terminals, and inhibiting the release of acetylcholine. This inhibition occurs as the
neurotoxin cleaves SNAP-25, a protein integral to the successful docking and release of
acetylcholine from vesicles situated within nerve endings
(collagenase clostridium histolyticum)
 Dupuytren’s contracture
 consisting of two microbial collagenases in a defined mass ratio, Collagenase AUX-I and
Collagenase AUX-II, which are isolated and purified from the fermentation of
Clostridium histolyticum bacteria. Collagenases are proteinases that hydrolyze collagen
in its native triple helical conformation under physiological conditions, resulting in lysis
of collagen deposits. Injection of Xiaflex into a Dupuytren’s cord, which is comprised
mostly of collagen, may result in enzymatic disruption of the cord

(carglumic acid
 Erammonemia
 synthetic structural analogue of N-acetylglutamate (NAG), which is an essential allosteric
activator of carbamoyl phosphate synthetase 1 (CPS 1) in liver mitochondria. CPS 1 is
the first enzyme of the urea cycle, which converts ammonia into urea. NAG is the
product of N-acetylglutamate synthase (NAGS), a mitochondrial enzyme. Carglumic acid
acts as a replacement for NAG in NAGS deficiency patients by activating CPS 1

(cabazitaxel)
is an orally bioavailable taxane anti-neoplastic agent. It works by disrupting the microtubular
network that is essential for mitotic and interphase cellular functions and causes inhibition of cell
division and cell death. Cabazitaxel has been shown to inhibit cell division and tumor cell
proliferation by binding to and stabilizing tubulin, a protein in the microtubules of cells which
provides a skeleton for maintaining cell shape

(rifaximin)
 hepatic encephalopathy recurrence in adults

N.Ramana Chary,M.S(Pharma),NIPER,Mohali. Page 2

 2010 FDA Approved Drugs as of 28th June,2010

 a non-aminoglycoside semi-synthetic, nonsystemic antibiotic derived from rifamycin.

Rifaximin acts by binding to the beta-subunit of bacterial DNA-dependent 507 RNA
polymerase resulting in inhibition of bacterial RNA synthesis.

(meningitis vaccine
 invasive meningococcal disease
 is a quadrivalent conjugated vaccine containing the Neisseria meningitidis serogroups A,
C, Y and W-135. The presence of serum bactericidal antibodies protects against invasive
meningococcal disease. Vaccination with Menveo leads to the production of bactericidal
antibodies directed against the capsular polysaccharides of serogroups A, C, Y and W-
135.

(Pneumococcal 13-valent Conjugate Vaccine

 invasive disease caused by Streptococcus pneumoniae
 is a sterile suspension of saccharides of the capsular antigens of Streptococcus
pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F. B-cells
produce antibodies in response to antigenic stimulation via T-dependent and T-
independent mechanisms. Prevnar 13, comprised of polysaccharides conjugated to a
carrier protein, elicits a T-cell dependent immune response. Protein carrier-specific T-
cells provide the signals needed for maturation of the B-cell response and generation of
B-cell memory. This type of response induces immune memory and elicits booster
responses on re-exposure in infants and young children to pneumococcal polysaccharides

(gatifloxacin ophthalmic solution

 bacterial conjunctivitis
 a fluoroquinolone antibacterial. Gatifloxacin inhibits DNA gyrase and topoisomerase IV.
DNA gyrase is an essential enzyme that is involved in the replication, transcription, and
repair of bacterial DNA. Topoisomerase IV is an enzyme known to play a key role in the
partitioning of the chromosomal DNA during bacterial cell division

(dalfampridine)
 walking in patients with multiple sclerosis
 is a potassium channel blocker, The mechanism by which dalfampridine exerts its
therapeutic effect has not been fully elucidated

(sipuleucel-T)
 hormone refractory prostate cancer
 an autologous cellular immunotherapy. While the precise mechanism of action is
unknown, Provenge is designed to induce an immune response targeted against PAP, an
antigen expressed in most prostate cancers

(doxepin)
 Insomnia
 binds with high affinity to the histamine H1 receptor where it functions as an antagonist.
The exact mechanism by which doxepin exerts its sleep maintenance effect is unknown
but is believed due to its antagonism of the H1 receptor

N.Ramana Chary,M.S(Pharma),NIPER,Mohali. Page 3

 2010 FDA Approved Drugs as of 28th June,2010

ketorolac tromethamine)
 moderate to severe pain
 non-steroidal anti inflammatory drug Ketorolac. Ketorolac is an analgesic that inhibits the
enzyme cylooxygenase (COX), an early component of the arachidonic acid cascade,
resulting in the reduced synthesis of prostaglandins, thromboxanes, and prostacyclin

(estradiol valerate + dienogest)

 Contraception
 is an estradiol-based oral contraceptive combining estradiol valerate with the progestin
dienogest.primarily by suppressing ovulation. Other possible mechanisms may include
cervical mucus changes that inhibit sperm penetration and endometrial changes that
reduce the likelihood of implant ation

(trazodone hydrochloride
 major depressive disorder
 acts as a dual serotonin agonist and serotonin reuptake inhibitor.

naproxen + esomeprazole
 arthritis in patients at risk for NSAID-associated ulcers
 naproxen, like that of other NSAIDs, is not completely understood but may be related to
prostaglandin synthetase inhibition. By acting specifically on the proton pump,
esomeprazole blocks the final step in acid production, thus reducing gastric acidity.

(hydromorphone hydrochloride) extended release

 moderate to severe pain
 a Schedule II a mu-opioid agonist.

(dutasteride + tamsulosin
 benign prostatic hyperplasia
 Dutasteride inhibits the conversion of testosterone to dihydrotestosterone (DHT), the
androgen primarily responsible for the initial development and subsequent enlargement
of the prostate gland. Tamsulosin, an alpha-blocker, is indicated for the treatment of the
signs and symptoms of BPH.Tamsulosin works by relaxing the muscles in the bladder
and prostate

Miconazole
 oropharyngeal candidiasis
 Miconazole works by inhibiting the synthesis of ergosterol, a critical component of
fungal cell membranes.. Miconazole also affects the synthesis of triglycerides and fatty
acids and inhibits oxidative and peroxidative enzymes, increasing the amount of reactive
oxygen species within the cell

aztreonam for inhalation solution

 cystic fibrosis patients with Pseudomonas aeruginosa
 a monobactam antibacterial.Aztreonam binds to penicillin binding proteins of susceptible
bacteria, which leads to inhibition of bacterial cell wall synthesis and death of the cell

N.Ramana Chary,M.S(Pharma),NIPER,Mohali. Page 4