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ORGANIC SPECTROSCOPY

Read all about Organic Spectroscopy on ORGANIC SPECTROSCOPY INTERNATIONAL 

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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 AFRICURE PHARMA, ROW2TECH, NIPER-G, Department of Pharmaceuticals, Ministry of Chemicals and Fertilizers, Govt. of India as ADVISOR, earlier assignment was with GLENMARK LIFE SCIENCES LTD, as CONSUlTANT, Retired from GLENMARK in Jan2022 Research Centre as Principal Scientist, Process Research (bulk actives) at Mahape, Navi Mumbai, India. Total Industry exp 32 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 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 32 PLUS year tenure till date Feb 2023, 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 100 million plus hits on Google, 2.5 lakh plus connections on all networking sites, 100 Lakh plus views on dozen plus blogs, 227 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 38 lakh plus views on New Drug Approvals Blog in 227 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 He has total of 32 International and Indian awards

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FDA Grants Priority Review To New Drug Application For MNK-795

August 5, 2013 3:13 am / 3 Comments on FDA Grants Priority Review To New Drug Application For MNK-795

FDA Grants Priority Review To New Drug Application For MNK-795 Submitted By Depomed Licensee Mallinckrodt

Controlled Substance Analgesic Combination Product Uses Depomed’s Proprietary Acuform® Technology

NEWARK, Calif., July 29, 2013 /PRNewswire/ — Depomed, Inc. (NASDAQ:DEPO) announced today that the U. S. Food and Drug Administration (FDA) has accepted for filing a New Drug Application (NDA) from Mallinckrodt (NYSE: MNK) for MNK-795.  MNK-795 is a controlled-release oral formulation of oxycodone and acetaminophen that has been studied for the management of moderate to severe acute pain where the use of an opioid analgesic is appropriate.  MNK-795 is formulated with Depomed’s Acuform® drug delivery technology.

 

http://www.pharmalive.com/fda-grants-priority-review-to-new-drug-application-for-mnk-795

FDA has granted tentative approval to India-based Strides Arcolab’s HIV drug emtricitabine and tenofovir disoproxil fumarate tablets, 200 mg/300 mg.

August 3, 2013 6:45 am / 3 Comments on FDA has granted tentative approval to India-based Strides Arcolab’s HIV drug emtricitabine and tenofovir disoproxil fumarate tablets, 200 mg/300 mg.

http://www.stridesarco.com/

chief executive and vice chairman Arun Kumar –Strides arcolab

deepak

Deepak Vaidya, chaiman

Headquartered in India, Strides Arcolab is a pharmaceutical company with a key focus on the development and manufacture of IP-led niche products, particularly sterile injectables. It is among the world’s largest manufacturers of soft gelatin capsules. With 14 world-class manufacturing facilities, an innovative R&D hub and a marketing network in 70 countries, Strides is well positioned to meet the demands of the global pharmaceutical industry and has partnered with several of the world’s leading pharmaceutical companies.

2 August 2013

Strides Arcolab’s HIV drug, which is generic version of Gilead Sciences’ Truvada, gets tentative approval from the US FDA.

Tentative approval implies that the drug has met all standards but cannot be marketed in the US due to existing patent protections Good news for HIV AIDS patients

FDA has granted tentative approval to India-based Strides Arcolab’s HIV drug emtricitabine and tenofovir disoproxil fumarate tablets, 200 mg/300 mg. The drug is a generic version of Truvada, 200 mg/300 mg tablets, which is manufactured by Gilead Sciences.

The product is indicated for use in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV)-1

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EMTRICITABINE

credit-chemdrug

The selective tosylation of L-gulose with tosyl chloride in pyridine, followed by complete acetylation with acetic anhydride gives tetraacetyl-6-O-tosyl-L-gulose (II), which is treated with HBr in AcOH to yield the bromo derivative (III ). The reaction of (III) with potassium O-ethylxanthate in refluxing acetone, followed by deacetylation with NH4OH in methanol affords 1,6-thioanhydro-L-gulopyranose (IV). The selective oxidative cleavage of (IV) by means of NaIO4 , followed by reduction with NaBH4 and protection of the resulting diol with acetone and TsOH provides the acetonide (V), which is silylated at the primary OH group with TBDMS-Cl giving the silyl ether (VI). Elimination of the acetonide group with TsOH in methanol yields the diol (VII), which is cleaved with Pb (OAc) 4 and oxidized with PDC in DMF to afford the carboxylic acid (VIII). The treatment of (VII) with Pb (OAc) 4/pyridine in THF furnishes the diacetate (IX), which is condensed with N4-acetyl-5-fluoro-O-(trimethylsilyl) cytosine (X) by means of TBDMS-OTf in dichloromethane yielding a mixture of the desired (-) (2R, 5S) – isomer (XI) along with its (+) – (2R, 5R)-isomer that is separated by column chromatography. Finally, deacetylation of (XI) with ammonia in methanol, followed by desilylation with TBAF in THF afforded the target compound.
Jeong, LS; et al.; Asymmetric synthesis and biological evaluation of beta-L-(2R, 5S) – and alpha-L-(2R, 5R) -1, 3-oxathiolane-pyrimidine and-purine nucleosides as potential anti- HIV agents. J Med Chem 1993, 36, 2, 181
………………………………….
TENOFOVIR

FDA gives tentative approval to Perrigo s ANDA for generic version of Prandin Tablets

July 21, 2013 1:48 am / Leave a comment

repaglinide

Perrigo Company (Nasdaq: PRGO; TASE) today announced that it has received tentative approval from the U.S. Food & Drug Administration (FDA) for its abbreviated new drug application (ANDA) for repaglinide tablets, the generic equivalent to Prandin® Tablets (repaglinide tablets).

Prandin® tablets (repaglinide tablets), are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type-2 diabetes mellitus and have annual sales of approximately $250 million, as measured by Symphony Health Solutions.

http://www.news-medical.net/news/20130720/FDA-gives-tentative-approval-to-Perrigos-ANDA-for-generic-version-of-Prandin-Tablets.aspx

Repaglinide is an antidiabetic drug in the class of medications known as meglitinides, and was invented in 1983. It is sold byNovo Nordisk under the name of Prandin in the U.S., GlucoNorm in Canada, Surepost in Japan, Repaglinide in Egypt by EIPICO, and NovoNorm elsewhere. In Japan it is produced by Dainippon Sumitomo Pharma.

Repaglinide lowers blood glucose by stimulating the release of insulin from the pancreas. It achieves this by closing ATP-dependent potassium channels in the membrane of the beta cells. This depolarizes the beta cells, opening the cells’ calcium channels, and the resulting calcium influx induces insulin secretion.

 

Actavis to Launch Generic Epilepsy/Bipolar Drug

July 17, 2013 3:14 am / 9 Comments on Actavis to Launch Generic Epilepsy/Bipolar Drug

LAMOTRIGINE

 

PARSIPPANY, N.J., July 15, 2013 (AP) — Drugmaker Actavis Inc. said Monday it’s received U.S. approval to sell a generic version of Lamictal, a tablet for treating epilepsy and bipolar disorder.

Actavis, based in Parsippany, N.J., said the Food and Drug Administration has granted approval for it to sell lamotrigine tablets in doses of 25, 50, 100 and 200 milligrams.http://www.pharmalive.com/actavis-to-launch-generic-epilepsybipolar-drug

Lamotrigine, marketed in the US and most of Europe as Lamictal /ləˈmɪktəl/ byGlaxoSmithKline, is an anticonvulsant drug used in the treatment of epilepsy and bipolar disorder. It is also used off-label as an adjunct in treating depression. For epilepsy, it is used to treat focal seizures, primary and secondary tonic-clonic seizures, and seizures associated with Lennox-Gastaut syndrome. Like many other anticonvulsant medications, Lamotrigine also seems to act as an effective mood stabilizer, and has been the first U.S.Food and Drug Administration (FDA)-approved drug for this purpose since lithium, a drug approved almost 30 years earlier. It is approved for the maintenance treatment of bipolar type I. Chemically unrelated to other anticonvulsants (due to lamotrigine’s being aphenyltriazine), lamotrigine has many possible side-effects. Lamotrigine is generally accepted to be a member of the sodium channel blocking class of antiepileptic drugs,but it could have additional actions since it has a broader spectrum of action than other sodium channel antiepileptic drugs such as phenytoin and carbamazepine and is effective in the treatment of the depressed phase of bipolar disorder, whereas other sodium channel blocking antiepileptic drugs are not. In addition, lamotrigine shares few side-effects with other, unrelated anticonvulsants known to inhibit sodium channels, which further emphasizes its unique properties. Lamotrigine is inactivated by hepatic glucuronidation.

Dr. Reddy’s Announces the Launch of Decitabine for Injection

July 15, 2013 3:40 am / 1 Comment on Dr. Reddy’s Announces the Launch of Decitabine for Injection

File:Decitabine2.png

Decitabine

Hyderabad, India, July 12, 2013 — Dr. Reddy’s Laboratories announced today that it has launched Decitabine for Injection (50mg) a therapeutic equivalent generic version of Dacogen (Decitabine for Injection) in the US market on July 11, 2013, following the approval by the United States Food & Drug Administration (USFDA) of Dr. Reddy’s ANDA for Decitabine for Injection.

The Dacogen brand has U.S. sales of approximately $260 Million MAT for the most recent twelve months ending in July 2013 according to IMS Health*.

Dr. Reddy’s Decitabine for Injection 50 mg is available as a single dose vial.

About Dr. Reddy’s

Dr. Reddy’s Laboratories Ltd. (NYSE: RDY) is an integrated global pharmaceutical company, committed to providing affordable and innovative medicines for healthier lives. Through its three businesses – Pharmaceutical Services and Active Ingredients, Global Generics and Proprietary Products – Dr. Reddy’s offers a portfolio of products and services including APIs, custom pharmaceutical services, generics, biosimilars, differentiated formulations and NCEs. Therapeutic focus is on gastro-intestinal, cardiovascular, diabetology, oncology, pain management, anti-infective and pediatrics. Major markets include India, USA, Russia and CIS, Germany, UK, Venezuela, S. Africa, Romania, and New Zealand. For more information, log on to: http://www.drreddys.com.

Dacogen® is a registered trademark used by Eisai Inc. under license from Astex Pharmaceuticals, Inc

Decitabine (trade name Dacogen), or 5-aza-2′-deoxycytidine, is a drug for the treatment of myelodysplastic syndromes, a class of conditions where certain blood cells are dysfunctional, and for acute myeloid leukemia (AML).[1] Chemically, it is a cytidine analog.

Decitabine is a hypomethylating agent.[2][3] It hypomethylates DNA by inhibiting DNA methyltransferase.

It functions in a similar manner to azacitidine, although decitabine can only be incorporated into DNA strands while azacitidine can be incorporated into both DNA and RNA chains.

Clinical uses

Decitabine is indicated for the treatment of myelodysplastic syndromes (MDS) including previously treated and untreated, de novo and secondary MDS of all French-American-British subtypes (refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, and chronic myelomonocytic leukemia) and Intermediate-1, Intermediate-2, and High-Risk International Prognostic Scoring System groups. In patients with renal insufficiency, Batty and colleagues reported the first case series on the feasibility of therapy with hypomethylating agents in patients with renal insufficiency.[4]

Chemical synthesis

Decitabine can be synthesized from a benzoyl-protected chlorosugar:[5] Decitabine.png

  1.  “EC Approves Marketing Authorization Of DACOGEN For Acute Myeloid Leukemia”. 2012-09-28. Retrieved 28 September 2012.
  2.  Kantarjian H, Issa JP, Rosenfeld CS, et al. (April 2006). “Decitabine improves patient outcomes in myelodysplastic syndromes: results of a phase III randomized study”. Cancer 106 (8): 1794–803. doi:10.1002/cncr.21792. PMID 16532500.
  3.  Kantarjian HM, O’Brien S, Cortes J, et al. (August 2003). “Results of decitabine (5-aza-2’deoxycytidine) therapy in 130 patients with chronic myelogenous leukemia”. Cancer 98 (3): 522–8. doi:10.1002/cncr.11543. PMID 12879469.
  4.  Ravandi, F.; Cortés, J. E.; O’Brien, S.; Pierce, S.; Garcia-Manero, G.; McCue, D.; Santos, F. P. S.; Jabbour, E. et al. (2010). “Feasibility of Therapy with Hypomethylating Agents in Patients with Renal Insufficiency”. Clinical Lymphoma, Myeloma & Leukemia 10 (3): 205–210. doi:10.3816/CLML.2010.n.032. PMID 20511166.  |displayauthors= suggested (help) edit
  5.  Piml, J.; Sorm, F. (1964). Coll. Czech. Chem. Commun. 29: 2576.

FDA clears Aurobindo’s Rizatriptan Benzoate orally disintegrating tablets

July 5, 2013 3:55 am / 2 Comments on FDA clears Aurobindo’s Rizatriptan Benzoate orally disintegrating tablets

India-based Aurobindo Pharma has obtained final FDA approvals to manufacture and market Rizatriptan Benzoate orally disintegrating tablets (ODT) 5mg and 10mg (ANDA 203062)…

read more at

http://drugdiscovery.pharmaceutical-business-review.com/news/fda-clears-aurobindos-rizatriptan-benzoate-orally-disintegrating-tablets-030713

 

Rizatriptan (trade name Maxalt) is a 5-HT1 agonist triptan drug developed by Merck & Co. for the treatment of migraine headaches. It is available in strengths of 5 and 10 mg as tablets and orally disintegrating tablets (Maxalt-MLT).

Maxalt obtained approval by the United States Food and Drug Administration (FDA) on June 29, 1998. It is a second-generation triptan.

Rizatriptan is available only by prescription in Australia, the United States, Canada andNew Zealand. Similarly, it is classed as a POM (Prescription Only Medicine) in the United Kingdom, Italy (as Rizaliv), Israel (as Rizalt), The Netherlands, Croatia and Spain (asMaxalt)

Amneal Pharma the 7th largest generic drug manufacturer in the US drug market has received ANDA approval for generic Skelaxin (metaxalone).

July 1, 2013 3:23 am / 4 Comments on Amneal Pharma the 7th largest generic drug manufacturer in the US drug market has received ANDA approval for generic Skelaxin (metaxalone).

metaxalone

READ ALL AT

http://www.pharmaintellect.com/2013/06/pfizer-skelaxin-to-face-competion-from.html?utm_source=feedburner&utm_medium=email&utm_campaign=Feed%3A+Pharmainvest+%28PharmaInvest%29

Metaxalone (marketed by King Pharmaceuticals under the brand name Skelaxin) is a muscle relaxant used to relax muscles and relieve pain caused by strains, sprains, and other musculoskeletal conditions. Its exact mechanism of action is not known, but it may be due to general central nervous system depression. It is considered to be a moderately strong muscle relaxant, with relatively low incidence of side effects. Skelaxin is available in an 800 mg scored tablet. Possible side effects include nausea, vomiting, drowsiness and CNS side effects, such as dizziness, headache, and irritability.

Metaxalone exhibits increased bioavailability when taken with food.[1] Specifically, in one study, compared to fasted conditions, the presence of food at the time of drug administration increased Cmax by 77.5%, AUC0-t by 23.5%, and AUC0-∞ by 15.4%.[2] Thus, based on the information in the labeling, patients receiving metaxalone therapy are directed to take metaxalone with food, and are informed that taking metaxalone with food results in an increase in the oral bioavailability of metaxalone compared to taking metaxalone without food.[3][4][5]

The metabolism of metaxalone involves the liver cytochrome P450 system. Based on the information in the labeling, patients receiving metaxalone therapy and physicians prescribing metaxalone are directed to take precaution when coadministering it with other medications involving the P450 system.[6][7]

Because of potential for side effects, this drug is on the list for high risk medications in the elderly.

A literature survey reveals very few methods are reported for the determination of metaxalone to date. Nirogi et al.[2] reported a liquid chromatographic method coupled to tandem mass spectrometry for the quantification of metaxalone in human plasma. A stability-indicating HPLC method was introduced by P.K. Sahu et al.[8] Metaxalone has been used as an internal standard for few analytical methods[9][10]

  1.  Skelaxin Package Insert
  2. Nirogi RV, Kandikere VN, Shukla M, Mudigonda K, Shrivastava W, Datla PV (May 2006). “Quantification of Metaxalone in Human Plasma by Liquid Chromatography Coupled to Tandem Mass Spectrometry”. J Anal Toxicol 30 (4): 245–51. PMID 16803662.
  3.  id.
  4.  United States Patent No. 6,407,128
  5.  United States Patent No. 6,683,102
  6.  United States Patent No. 7,122,566, by Jie Du, et al
  7.  United States Patent No. 7,378,434, by Jie Du, et al
  8.  Prafulla Kumar Sahu, M. Mathrusri Annapurna and Dillip Kumar Sahoo, Development and Validation of Stability Indicating RP-HPLC Method for the Determination of Metaxalone in Bulk and its Pharmaceutical Formulations; E-Journal of Chemistry, 2011, 8(S1), S439-S447.[1]
  9.  Mistri H N, Jangid A G, Pudage A, Gomes N, Sanyal M and Shrivastav P, J Chromatogr B, 2007, 853(1), 320-332.
  10.  Mistri H N, Jangid A G, Pudage A and Shrivastav P, J Chromatogr B, 2008, 864(1-2), 137-148.

FDA Approves Pediatric Indication for Astellas’ Mycamine (micafungin sodium) for Injection

June 25, 2013 3:04 am / Leave a comment

File:Micafungin.svg

micafungin sodium

  • C56-H70-N9-O23-S.Na
    1292.265
    Fujisawa (Originator), Merck & Co. (Codevelopment)
    Antifungal Agents, ANTIINFECTIVE THERAPY, 1,3-beta-Glucan Synthase Inhibitors, Echinocandins
    Launched-2002

{5-[(1S,2S)-2-[(3S,6S,9S,11R,15S,18S,20R,21R,24S,25S,26S)-3-[(1R)-2-carbamoyl-1-hydroxyethyl]-11,20,21,25-tetrahydroxy-15-[(1R)-1-hydroxyethyl]-26-methyl-2,5,8,14,17,23-hexaoxo-18-[(4-{5-[4-(pentyloxy)phenyl]-1,2-oxazol-3-yl}benzene)amido]-1,4,7,13,16,22-hexaazatricyclo[22.3.0.09,13]heptacosan-6-yl]-1,2-dihydroxyethyl]-2-hydroxyphenyl}oxidanesulfonic acid

June 24, 2013 , Astellas Pharma US, Inc. (“Astellas”), a U.S. subsidiary of Tokyo-based Astellas Pharma Inc. (Tokyo: 4503), announced that the U.S. Food and Drug Administration (FDA) has approved its Supplemental New Drug Application (sNDA) for the use of MYCAMINE® (micafungin sodium) for injection by intravenous infusion for the treatment of pediatric patients four months and older with candidemia, acute disseminated candidiasis, Candida peritonitis and abscesses, esophageal candidiasis, and prophylaxis of Candida infections in patients undergoing hematopoietic stem cell transplants (HSCT).

http://www.drugs.com/newdrugs/fda-approves-pediatric-indication-astellas-mycamine-micafungin-sodium-3827.html

Micafungin (trade name Mycamine) is an echinocandin antifungal drug developed by Astellas Pharma. It inhibits the production of beta-1,3-glucan, an essential component of fungal cell walls. Micafungin is administered intravenously. It received final approval from the U.S. Food and Drug Administration on March 16, 2005, and gained approval in the European Union on April 25, 2008.

Micafungin is indicated for the treatment of candidemia, acute disseminated candidiasis, Candida peritonitis, abscesses and esophageal candidiasis. Since January 23, 2008, micafungin has been approved for the prophylaxis of Candida infections in patients undergoing hematopoietic stem cell transplantation (HSCT).

Micafungin works by way of concentration-dependent inhibition of 1,3-beta-D-glucan synthase resulting in reduced formation of 1,3-beta-D-glucan, which is an essential polysaccharide comprising one-third of the majority of Candida spp. cell walls. This decreased glucan production leads to osmotic instability and thus cellular lysis

  • Micafungin sodium, FK-463, Mycamine, Funguard,208538-73-2

  • The synthesis of FK-463 can be performed as follows: The enzymatic deacylation of FR-901379 with Streptomyces anulatas No. 4811, S. anulatas No. 8703, Streptomyces strain No. 6907 or A. utahensis IFO13244 gives the deacylated lipopeptide FR-179642 (1), which is then reacylated with 1-[4-[5-(4-pentyloxyphenyl)isoxazol-3-yl]benzoyl]benzotriazole 3-oxide (VI) by means of dimethylaminopyridine (DMAP) in DMF. The acylating compound (VI) can be obtained as follows: The cyclization of 4-pentyloxyphenylacetylene (I) with 4-(hydroxyiminomethyl)benzoic acid methyl ester (II) by means of triethylamine in hot THF gives 4-[5-(4-pentyloxyphenyl)isoxazol-3-yl]benzoic acid methyl ester (III), which is hydrolyzed with NaOH in hot THF/water yielding the corresponding free acid (IV). Finally, this compound is condensed with 1-hydroxybenzotriazole (V) by means of 1-ethyl-3-[3-(dimethylamino)propyl]carbodiimide (EDMCA) in dichloromethane.
    Fromtling, R.A.; Castr, Drugs Fut 1998, 23, 12, 1273
    The synthesis of FK-463 can be performed as follows: The enzymatic deacylation of FR-901379 with Streptomyces anulatas No. 4811, S. anulatas No. 8703, Streptomyces strain No. 6907 or A. utahensis IFO13244 gives the deacylated lipopeptide FR-179642 (1), which is then reacylated with 1-[4-[5-(4-pentyloxyphenyl)isoxazol-3-yl]benzoyl]benzotriazole 3-oxide (VI) by means of dimethylaminopyridine (DMAP) in DMF. The acylating compound (VI) can be obtained as follows: The cyclization of 4-pentyloxyphenylacetylene (I) with 4-(hydroxyiminomethyl)benzoic acid methyl ester (II) by means of triethylamine in hot THF gives 4-[5-(4-pentyloxyphenyl)isoxazol-3-yl]benzoic acid methyl ester (III), which is hydrolyzed with NaOH in hot THF/water yielding the corresponding free acid (IV). Finally, this compound is condensed with 1-hydroxybenzotriazole (V) by means of 1-ethyl-3-[3-(dimethylamino)propyl]carbodiimide (EDMCD) in dichloromethane.
  • 38th Intersci Conf Antimicrob Agents Chemother (Sept 24 1998, San Diego)1998,:Abst F-145

Forest Announces U.S. Availability of New Once-Daily NAMENDA XR

June 16, 2013 4:16 am / Leave a comment

 

memantine

Forest Announces U.S. Availability of New Once-Daily NAMENDA XR

— Treatment for moderate to severe Alzheimer’s Disease is now available to patients in a convenient extended release formulation —

NYSE:FRX.NEW YORK–(BUSINESS WIRE)–Forest Laboratories, Inc. announced today that NAMENDA XR(TM) (memantine hydrochloride) once-daily formulation is now available in pharmacies throughout the United States. NAMENDA XR is approved by the U.S. Food and Drug Administration (FDA) for the treatment of moderate to severe dementia of the Alzheimer’s type.

http://www.pharmalive.com/once-daily-namenda-xr-launched-in-us

Memantine is the first in a novel class of Alzheimer’s disease medications acting on theglutamatergic system by blocking NMDA-type glutamate receptors. It was first synthesized by Eli Lilly and Company in 1968. Memantine is marketed under the brandsAxura and Akatinol by Merz, Namenda by Forest, Ebixa and Abixa by Lundbeck andMemox by Unipharm. Memantine has been shown to have a modest effect in moderate-to-severe Alzheimer’s disease  and in dementia with Lewy bodies. Despite years of research, there is little evidence of effect in mild Alzheimer’s disease.

DRUG SCALEUP AND MANUFACTURING INTERNATIONAL BY DR ANTHONY M CRASTO, WORLD DRUG TRACKER

June 14, 2013 4:04 am / 7 Comments on DRUG SCALEUP AND MANUFACTURING INTERNATIONAL BY DR ANTHONY M CRASTO, WORLD DRUG TRACKER

http://drug-scaleup-and-manufacturing.webnode.com/news/my-website-on-scaleup-of-organic-compounds/

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