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Home » NEW DRUGS » Pernix Therapeutics Holdings, Inc., a specialty pharmaceutical company, today announced that its subsidiary, Hawthorn Pharmaceuticals, Inc., has received FDA approval of a NDA for Vituz Oral Solution (hydrocodone bitartrate and chlorpheniramine maleate).

Pernix Therapeutics Holdings, Inc., a specialty pharmaceutical company, today announced that its subsidiary, Hawthorn Pharmaceuticals, Inc., has received FDA approval of a NDA for Vituz Oral Solution (hydrocodone bitartrate and chlorpheniramine maleate).

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Hydrocodone bitartrate is morphinan-6-one, 4,5-epoxy-3-methoxy-17-methyl-, (5α)-, [R-(R*,R*)]-2,3-dihydroxybutanedioate (1:1), hydrate (2:5); also known as 4,5α-Epoxy-3-methoxy-17-methylmorphinan-6-one tartrate (1:1) hydrate (2:5); a fine white crystal or crystalline powder, which is derived from the opium alkaloid, thebaine; and may be represented by the following structural formula:

Hydrocodone bitartrate Structural Formula Illustration

Hydrocodone Bitartrate
C18H21N03•C4H606•2.5 H20
Molecular weight = 494.5

Chlorpheniramine maleate is 2-pyridinepropanamine, γ-(4-chlorophenyl)-N,N-dimethyl-, (Z)-2-butenedioate (1:1) and has the following chemical structure:

Chlorpheniramine maleate Structural Formula Illustration

Chlorpheniramine Maleate
C16H19C1N2•C4H404
Molecular weight = 390.86

Feb 28, 2013 – Pernix Therapeutics Holdings, Inc., a specialty pharmaceutical company, today announced that its subsidiary, Hawthorn Pharmaceuticals, Inc., has received U.S. Food and Drug Administration (FDA) approval of a new drug application (NDA) for Vituz Oral Solution (hydrocodone bitartrate and chlorpheniramine maleate). Vituz is indicated for the relief of cough and symptoms associated with upper respiratory allergies or a common cold in adults 18 years of age and older.

Cooper Collins, President and CEO of Pernix, said, “Vituz broadens our cough and cold product line and is our first NDA approved by the FDA, since we closed the acquisition of Hawthorn and Cypress at the end of December 2012. We look forward to the launch of this new treatment option for cough and cold symptoms, which is expected prior to the fall of this year.”


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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 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 year tenure till date Dec 2017, 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, 50 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 19 lakh plus views on New Drug Approvals Blog in 216 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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