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Tivorbex (indomethacin); Iroko Pharmaceuticals; For the treatment of acute pain,

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Tivorbex (indomethacin); Iroko Pharmaceuticals; For the treatment of acute pain, Approved February of 2014

2-{1-[(4-chlorophenyl)carbonyl]-5-methoxy-2-methyl-1H-indol-3-yl}acetic acid

cas 53-86-1

PHILADELPHIA—Iroko Pharmaceuticals, LLC, a global specialty pharmaceutical company dedicated to advancing the science of analgesia, today announced that the U.S. Food and Drug Administration (FDA) has approved TIVORBEX™ (indomethacin) capsules, a nonsteroidal anti-inflammatory drug (NSAID), at 20 mg and 40 mg doses for the treatment of mild to moderate acute pain in adults1.

“TIVORBEX is the second NSAID to be approved from Iroko’s lower dose NSAID pipeline that uses proprietary SoluMatrix Fine Particle Technology™.”

TIVORBEX was approved at dosage strengths that are 20 percent lower than the 25 mg and 50 mg indomethacin products currently on the market2. FDA approval of TIVORBEX was supported by data from two Phase 3 multi-center, placebo-controlled trials that demonstrated significant improvement in pain relief in patients with post-surgical acute pain receiving TIVORBEX compared with patients receiving placebo3.

“The FDA approval of TIVORBEX is another significant milestone for Iroko as it validates our strategic approach towards developing a suite of NSAID products that offer pain management at lower doses,” said John Vavricka, President and CEO of Iroko Pharmaceuticals. “TIVORBEX is the second NSAID to be approved from Iroko’s lower dose NSAID pipeline that uses proprietary SoluMatrix Fine Particle Technology™.”  read at

http://www.businesswire.com/news/home/20140224006983/en/Iroko-Pharmaceuticals-Receives-FDA-Approval-TIVORBEX%E2%84%A2#.Uw7ui-PoSuo

Indometacin (INN) or indomethacin (USAN and former BAN) is a non-steroidal anti-inflammatory drug (NSAID) commonly used as a prescriptionmedication to reduce feverpain, stiffness, and swelling. It works by inhibiting the production of prostaglandins, molecules known to cause these symptoms. It is marketed under more than seventy different trade names.[1]

 

Indomethacin was discovered in 1963[8] and it was first approved for use in the U.S. by the Food and Drug Administration in 1965. Its mechanism of action, along with several other NSAIDs that inhibit COX, was described in 1971.[9]

References

  1.  Trade names are listed on DrugBank.ca entry DB00328
  2. Sanders, Lisa (6 January 2012). “Think Like a Doctor: Ice Pick Pain Solved!”The New York Times.
  3.  Garza, I & Schwedt, TJ. “Hemicrania continua.” UpToDate.http://www.uptodate.com/contents/hemicrania-continua. Accessed 8/27/13.
  4.  Smyth JM, Collier PS, Darwish M et al. (September 2004). “Intravenous indometacin in preterm infants with symptomatic patent ductus arteriosus. A population pharmacokinetic study”Br J Clin Pharmacol 58 (3): 249–58. doi:10.1111/j.1365-2125.2004.02139.x.PMC 1884560PMID 15327584.
  5.  “INDOMETHACIN”Hazardous Substances Data Bank (HSDB). National Library of Medicine’s TOXNET. Retrieved April 4, 2013.
  6.  Giles W, Bisits A (October 2007). “Preterm labour. The present and future of tocolysis”. Best Pract Res Clin Obstet Gynaecol 21 (5): 857–68. doi:10.1016/j.bpobgyn.2007.03.011.PMID 17459777.
  7.  Akbarpour F, Afrasiabi A, Vaziri N (1985). “Severe hyperkalemia caused by indomethacin and potassium supplementation”. South Med J 78 (6): 756–7. doi:10.1097/00007611-198506000-00039PMID 4002013.
  8.  Hart F, Boardman P (October 1963). “Indomethacin: A New Non-steroid Anti-inflammatory Agent”Br Med J 2 (5363): 965–70. doi:10.1136/bmj.2.5363.965PMC 1873102.PMID 14056924.
  9. Ferreira S, Moncada S, Vane J (Jun 23, 1971). “Indomethacin and aspirin abolish prostaglandin release from the spleen”. Nat New Biol 231 (25): 237–9.doi:10.1038/231237a0PMID 5284362.

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DR ANTHONY CRASTO

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DR ANTHONY MELVIN CRASTO Ph.D

DR ANTHONY MELVIN CRASTO Ph.D

DR ANTHONY MELVIN CRASTO, Born in Mumbai in 1964 and graduated from Mumbai University, Completed his Ph.D from ICT, 1991,Matunga, Mumbai, India, in Organic Chemistry, The thesis topic was Synthesis of Novel Pyrethroid Analogues, Currently he is working with GLENMARK PHARMACEUTICALS LTD, Research Centre as Principal Scientist, Process Research (bulk actives) at Mahape, Navi Mumbai, India. Total Industry exp 29 plus yrs, Prior to joining Glenmark, he has worked with major multinationals like Hoechst Marion Roussel, now Sanofi, Searle India Ltd, now RPG lifesciences, etc. He has worked with notable scientists like Dr K Nagarajan, Dr Ralph Stapel, Prof S Seshadri etc, He did custom synthesis for major multinationals in his career like BASF, Novartis, Sanofi, etc., He has worked in Discovery, Natural products, Bulk drugs, Generics, Intermediates, Fine chemicals, Neutraceuticals, GMP, Scaleups, etc, he is now helping millions, has 9 million plus hits on Google on all Organic chemistry websites. His friends call him worlddrugtracker. His New Drug Approvals, Green Chemistry International, All about drugs, Eurekamoments, Organic spectroscopy international, etc in organic chemistry are some most read blogs He has hands on experience in initiation and developing novel routes for drug molecules and implementation them on commercial scale over a 29 year tenure till date Aug 2016, Around 30 plus products in his career. He has good knowledge of IPM, GMP, Regulatory aspects, he has several International patents published worldwide . He has good proficiency in Technology transfer, Spectroscopy, Stereochemistry, Synthesis, Polymorphism etc., He suffered a paralytic stroke/ Acute Transverse mylitis in Dec 2007 and is 90 %Paralysed, He is bound to a wheelchair, this seems to have injected feul in him to help chemists all around the world, he is more active than before and is pushing boundaries, He has 9 million plus hits on Google, 2.5 lakh plus connections on all networking sites, 25 Lakh plus views on dozen plus blogs, He makes himself available to all, contact him on +91 9323115463, email amcrasto@gmail.com, Twitter, @amcrasto , He lives and will die for his family, 90% paralysis cannot kill his soul., Notably he has 13 lakh plus views on New Drug Approvals Blog in 212 countries......https://newdrugapprovals.wordpress.com/ , He appreciates the help he gets from one and all, Friends, Family, Glenmark, Readers, Wellwishers, Doctors, Drug authorities, His Contacts, Physiotherapist, etc

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