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FDA Approves Tris Pharma’s New Drug Application for Karbinal ER

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Carbinoxamine Maleate

C16H19ClN2O·C4H4O4 406.86
Ethanamine,2-[(4-chlorophenyl)-2-pyridinylmethoxy]-N,N-dimethyl-,(Z)-2-butenedioate (1:1).
2-[p-Chloro-a-[2-(dimethylamino)ethoxy]benzyl]pyridine maleate (1:1) [3505-38-2].

April 3, 2013

Tris Pharma, a specialty pharmaceutical company focused on developing innovative drug delivery technologies, today announced that the U.S. Food and Drug Administration (FDA) has approved its New Drug Application (NDA) for Karbinal ER (carbinoxamine maleate) Extended-release Oral Suspension 4mg/5mL, the first sustained-release histamine receptor blocking agent indicated for the treatment of seasonal and perennial allergic rhinitis in children ages 2 and up.

“Karbinal ER is dosed only once every 12 hours, making it an attractive treatment option for the millions of allergy sufferers who don’t respond to second-generation antihistamines and aren’t satisfied with the cumbersome dosing schedules associated with the first-generation antihistamines,” said Ketan Mehta, founder, President, and CEO of Tris Pharma. “The approval of Karbinal ER marks our fourth liquid extended-release NDA approval based upon our proprietary OralXR+ technology. We are in the process of finalizing our marketing partner and plan to launch later this year in anticipation of the fall allergy season.”

Based on physician interviews approximately 30 percent of patients don’t get adequate relief from the non-sedating antihistamines. Carbinoxamine is a mildly-sedating antihistamine with years of proven safety and efficacy. Prior to 2006, carbinoxamine was widely used, with dozens of carbinoxamine-containing combination products including extended-release solid-dose products. However, nearly all of these were older products that hadn’t gone through the FDA’s rigorous approval process. Following the Drug Efficacy Study Implementation (DESI) review, the FDA removed all unapproved products with the exception of two immediate-release formulations, creating a void for patients and doctors who valued the benefits associated with an extended-release formulation.

Dr. Laura Garabedian, a New York-based pediatrician, said, “While I’ve always found carbinoxamine to be an effective option for treating the symptoms of allergies in children, the existing immediate-release formulations of carbinoxamine require dosing multiple times a day. This is especially inconvenient for children who are in school. Now, with the approval of Karbinal ER, I look forward to having an effective and great-tasting extended-release liquid formulation to offer patients as young as two years old.”

Karbinal ER Extended-release Oral Suspension is an H1 receptor antagonist indicated for the symptomatic treatment of:

  • Seasonal and perennial allergic rhinitis
  • Vasomotor rhinitis
  • Allergic conjunctivitis due to inhalant allergens and foods
  • Mild, uncomplicated allergic skin manifestations of urticaria and angioedema
  • Dermatographism
  • As therapy for anaphylactic reactions adjunctive to epinephrine and other standard measures after the acute manifestations have been controlled
  • Amelioration of the severity of allergic reactions to blood or plasma

Tris Pharma is a specialty pharmaceutical company focused on the research and development of technologies-driven products. Tris has pioneered the delivery of sustained release in the liquid, chewable/ODT and strip dosage forms so patients do not have to swallow a pill. Tris’ Nobuse™ technology provides abuse deterrence for opioids and other abuse-prone drugs. Tris’ R&D and manufacturing facilities are located in Monmouth Junction, New Jersey, U.S.A. For more information, please visit http://www.trispharma.com.


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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 LIFE SCIENCES LTD, Research Centre as Principal Scientist, Process Research (bulk actives) at Mahape, Navi Mumbai, India. Total Industry exp 30 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, Dr T.V. Radhakrishnan and Dr B. K. Kulkarni, 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 Open superstar 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 30 PLUS year tenure till date June 2021, Around 35 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, 90 Lakh plus views on dozen plus blogs, 233 countries, 7 continents, 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 33 lakh plus views on New Drug Approvals Blog in 233 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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