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Channel: DR ANTHONY MELVIN CRASTO Ph.D – New Drug Approvals
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Lobeglitazone sulfate (Duvie)

Lobeglitazone Sulfate, CKD-501, IDR-105 (Duvie®)Approved KOREA Chong Kun Dang (Originator) Adjunct to diet and exercise to improve glycemic control in adults with type 2 Diabetes mellitus A dual PPARα...

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AZD 3514 MALEATE

AZD3514; AZD 3514; AZD-3514. CAS 1240299-33-5 Chemical Formula: C25H32F3N7O2 Exact Mass: 519.25696...

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AZD 1981

AZD1981; AZD-1981; 802904-66-1; UNII-2AD53WQ2CX; ; AZD 1981; Molecular Formula: C19H17ClN2O3S Molecular Weight: 388.86788 g/mol 1H-Indole-1-acetic acid,...

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Belinostat (PXD101), a novel HDAC inhibitor

Belinostat (PXD101)  FAST TRACK FDA , ORPHAN STATUS PXD101;PX105684;PXD-101;PXD 101;PX-105684 UNII:F4H96P17NZ N-Hydroxy-3-(3-phenylsulphamoylphenyl)acrylamide...

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Pidotimod, 匹多莫德 , пидотимод , بيدوتيمود ,

  Pidotimod H-Pyr-Thz-OH (4R)-3-[(2S)-5-oxopyrrolidine-2-carbonyl]-1,3-thiazolidine-4-carboxylic acid CAS 121808-62-6 Thymodolic acid, Pidotimod, Timodolic acid, PGT/1A, Axil, Onaka, Pigitil, Polimod...

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Carbotegravir, Dolutegravir, New Patent, WO 2016113372, Lek Pharmaceutical...

WO 2016113372 Carbotegravir, New Patent, WO 2016113372, Lek Pharmaceutical and Chemical Co DD LEK PHARMACEUTICALS D.D. [SI/SI]; Verovskova 57 1526 Ljubljana (SI) MARAS, Nenad; (SI). SELIC, Lovro;...

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WO 2016113415, Sandoz, Riociguat, New Patent

WO 2016113415, Sandoz, Riociguat, New Patent STEFINOVIC, Marijan; (AT). RICHTER, Frank; (AT). GRIESSER, Ulrich; (AT). LANGES, Christoph; (AT) SANDOZ AG [CH/CH]; Lichtstrasse 35 4056 Basel (CH) WO...

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Mifamurtide (Mepact) мифамуртид , ميفامورتيد , 米法莫肽 ,

Mifamurtide (Mepact) MF C59H109N6O19P MW 1237.499 CGP-19835, MFCD09954133, MTP-cephalin, Mtp-PE Muramyl tripeptide phosphatidylethanolamine...

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Delamanid, (Deltyba) デラマニド

Delamanid デラマニド MKT as Deltyba® by Otsuka Pharmaceutical http://www.ama-assn.org/resources/doc/usan/delamanid.pdf...

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Prucalopride succinate (Resolor)

Prucalopride (Resolor) CAS 179474-81-8 , R-093877; R-108512 4-Amino-5-chlor-N-[1-(3-methoxypropyl)-4-piperidinyl]-2,3-dihydro-1-benzofuran-7-carboxamid R-093877|R-108512|Resolor® Resolor;Resotran...

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SPIRONOLACTONE, спиронолактон , سبيرونولاكتون , 螺内酯 ,

Spironolactone Spironolactone, Supra-puren, Suracton, спиронолактон, سبيرونولاكتون , 螺内酯 , Abbolactone, Aldactide, SNL, Spiroctanie, Sprioderm, Verospirone,  Opianin...

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WHO Draft on Analytical Method Validation

DRUG REGULATORY AFFAIRS INTERNATIONAL The World Health Organization (WHO) recently published a draft document on analytical method Validation for comment. Read more about the draft “Guidelines on...

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MHRA GxP Data Integrity Definitions and Guidance for Industry: New Draft...

DRUG REGULATORY AFFAIRS INTERNATIONAL In January and March 2015, the U.K. Medicines and Healthcare Products Regulatory Agency (MHRA) published a “GMP Data Integrity Definitions and Guidance for...

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Written Confirmation expired: Can an API still be imported when produced...

DRUG REGULATORY AFFAIRS INTERNATIONAL What needs to be considered if an API is produced in the time period of a valid written confirmation but imported after this confirmation has expired? This is...

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Varenicline (Chantix™) バレニクリン酒石酸塩

Varenicline (Chantix™) Varenicline MF C13H13N3 MW 211.26 (1R,12S)-5,8,14-Triazatétracyclo[10.3.1.02,11.04,9]hexadéca-2,4,6,8,10-pentaène [French] [ACD/IUPAC Name]...

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FDA approves Adlyxin (lixisenatide) to treat type 2 diabetes

    FDA approves Adlyxin to treat type 2 diabetes 07/28/2016 07:53 AM EDT The U.S. Food and Drug Administration approved Adlyxin (lixisenatide), a once-daily injection to improve glycemic control...

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VELPATASVIR (GS-5816), GILEAD SCIENCES, велпатасвир, فالباتاسفير , 维帕他韦 ,

VELPATASVIR (GS-5816), GILEAD SCIENCES CAS 1377049-84-7 Molecular Formula: C49H54N8O8 Molecular Weight: 883.00186 g/mol Hepatitis C virus NS 5 protein inhibitors KEEP WATCHING AS I ADD MORE DATA,...

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Biafungin, CD 101, a Novel Echinocandin for Vulvovaginal candidiasis

  as  CH3COOH salt CD 101 Biafungin™; CD 101 IV; CD 101 Topical; CD101; SP 3025, Biafungin acetate UNII-G013B5478J FRE FORM, CAS 1396640-59-7 FREE FORM MF, C63-H85-N8-O17, MW, 1226.4035 Echinocandin...

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ANIDULAFUNGIN

OR Anidulafungin V-Echinocandin CAS Number 166663-25-8...

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GSK-2041706A, Potent GPR119 Receptor Agonists

GSK-2041706A [2-([(1S)-1-(1-[3-(1-methylethyl)-1,2,4-oxadiazol-5-yl]-4-piperidinyl)ethyl]oxy)-5-[4-(methylsulfonyl)phenyl]pyrazine]...

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