New Drug Approvals

Lu AE58054


C20H19F5N2O, 398.37


1H-​Indole-​3-​ethanamine, 6-​fluoro-​N-​[[3-​(2,​2,​3,​3-​tetrafluoropropoxy)​phenyl]​methyl]​-


CAS No: 467458-02-2  hydrochloride, M.Wt: 434.83
Lu AE58054 Hydrochloride Formula: C20H20ClF5N2O


H. Lundbeck A/S (Lundbeck) and Otsuka Pharmaceutical Co., Ltd. (Otsuka) today announced a license and development agreement for Lu AE58054, a selective 5HT6receptor antagonist currently in development for the treatment of Alzheimer’s disease. Under the terms of the agreement, Lundbeck will grant Otsuka co-development and co-commercialization rights to Lu AE58054 in the U.S., Canada, East Asia including Japan, major European countries and Nordic countries.

Lu AE58054 is a potent and selective 5-HT6 receptor antagonist under development byLundbeck as an augmentation therapy for the treatment of cognitive deficits associated with Alzheimer’s disease and schizophrenia.[1][2]

Phase III trials recently began for Lu-AE58054, a novel 5-HT6 antagonist for Alzheimer’s disease (AD) from H Lundbeck and Otsuka. Lu-AE58054 already demonstrated significant improvement of cognitive function in an earlier phase II trial when administered with Aricept.


This orally…

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New Drug Approvals


27 MAR 2013

The clock is ticking for Sarepta Therapeutics , a multitude of biotech investors and the boys who suffer from Duchenne muscular dystrophy.

Armed with promising Phase IIb data from a small study of eteplirsen involving only 12 patients with the lethal disease, Sarepta CEO Chris Garabedian is completing one of the most closely-watched high wire acts in the industry. At a time most companies would be focused solely on organizing a pivotal late-stage study, there’s intense speculation that the biotech will shoot for an accelerated approval with the data in hand. And it all comes down to their sit-down with the FDA to review mid-stage data.

Eteplirsen, also called AVI-4658, is an experimental drug, currently in clinical trials. It is designed for treatment of some mutations which cause Duchenne muscular dystrophy (DMD), a genetic degenerative muscle disease. Eteplirsen is a product of Sarepta Therapeutics

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New Drug Approvals


CAS Number: 128607-22-7

OSPHENA is indicated for the treatment of moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy, due to menopause

Also known as:
  • CCRIS 9205
  • Deamino-hydroxytoremifene
  • Fc-1271
  • FC-1271a
  • Ospemifene
  • Osphena

Molecular Formula: C24H23ClO2
Molecular Weight: 378.89 g.mol-1

Ospemifene, FC-1271a
Orion Corp. (Originator), Hormos (Codevelopment) 

Marja Sodervall, Maire Eloranta, Arja Kalapudas, Brian Kearton, Michael McKenzie, “METHODSFORTHEPREPARATION OF FISPEMIFENEFROMOSPEMIFENE.” U.S. Patent US20080214860, issued September 04, 2008.



Patent No


PatentExpireyDate patent use code
6245819 Jul 21, 2020 U-1369
8236861 Aug 11, 2026 U-1369
8236861 Aug 11, 2026 U-1370
Exclusivity Code ExclusivityDate
NCE Feb 26, 2018


Date of issue ofmarketing authorisation valid throughout the European Union 15/01/2015


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New Drug Approvals

Good News For Pfizer’s Orphan Drug Bosulif (Bosutinib) in Europe



mar 28,2013

Regulators in Europe have given a partial green light to Pfizer ‘s leukaemia drug Bosulif.

The European Commission has granted conditional marketing authorisation for Bosulif (bosutinib) for the treatment of adults with chronic, accelerated or blast phase Philadelphia chromosome-positive (Ph+) chronic myelogenous leukaemia (CML). The drug can be given to patients previously treated with one or more tyrosine kinase inhibitors ie Novartis’ Gleevec (imatinib) and Tasigna (nilotinib) or Bristol-Myers Squibb’s Sprycel (dasatinib).

The European Medicines Agency’s  (EMA) Committee for Medicinal Products for Human Use (CHMP) on January 17, 2013, adopts a positive opinion, recommending a conditional marketing authhorization for Pfizer’s orphan drug Bosulif (Bosutinib) for Chronic Leukemia (CML).  Bosutinib receives orphan designation from the European Commission (EC) on August 4, 2010, for CML.

Pfizer receives FDA approval on September 4, 2012, for orphan drug Bosulif (Bosutinib) for CML…

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New Drug Approvals

({[(S)-1-(4-amino-2-oxo-1,2-dihydropyrimidin-1-yl)-3-hydroxypropan-2-yl]oxy}methyl)phosphonic acid


Cidofovir is an injectable antiviral medication for the treatment of cytomegalovirus (CMV)retinitis[1] in patients with AIDS. It suppresses CMV replication by selective inhibition of viral DNA polymerase and therefore prevention of viral replication and transcription.[2] It is an acyclic nucleoside phosphonate, and is therefore independent of phosphorylation by viral enzymes,[3] in contrast to, for instance, acyclovir.

Maintenance therapy with cidofovir involves an infusion only once every two weeks, making it a convenient treatment option. Because dosing is relatively infrequent, a permanent catheter is not necessary for infusions.

Cidofovir was discovered at the Institute of Organic Chemistry and Biochemistry, Prague, by Antonín Holý, and developed by Gilead Sciences and is marketed with the brand name Vistide by Gilead in the USA, and by Pfizer elsewhere.


Cidofovir syn.png

Brodfuehrer, P; Howell, Henry G.; Sapino, Chester; Vemishetti, Purushotham (1994). “A practical synthesis of (S)-HPMPC”.Tetrahedron Letters 35 (20): 3243. doi:10.1016/S0040-4039(00)76875-4.

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New Drug Approvals

Vibativ (telavancin)

12 MAR 2013

Clinigen Group and Theravance have signed an exclusive commercialization agreement for Vibativ (telavancin) in the EU and few other countries located in Europe.

The bactericidal, once-daily injectable lipoglycopeptide antibacterial agent is indicated for nosocomial pneumonia, including ventilator-associated pneumonia, believed to be caused by methicillin resistant Staphylococcus aureus when no other alternatives are suitable.

Clinigen chief executive officer Peter George said, “VIBATIV is a second product for Clinigen’s Specialty Pharmaceuticals (SP) portfolio, complementing the division’santi-viral product, Foscavir.”

Under the deal, Clinigen will make 5m upfront payment to Theravance that is even entitled to earn sales based royalties.

The agreement is signed for a minimum of 15 years, with an option to extend exercisable by Clinigen.

Theravance chief executive officer Rick Winningham said, “We look forward to working with Clinigen in making VIBATIV available to patients with nosocomial pneumonia in the EU.”

Telavancin (trade name Vibativ)…

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New Drug Approvals

877606-63-8 cas no of afacifenacin

any str error, mail to

SMP-986 (afacifenacin fumarate)

(4S)-4-phenyl-3-(1-{[3-(trifluoromethoxy)phenyl]methyl}piperidin- 4-yl)-3,4-dihydroquinazolin-2(1H)-one muscarinic receptor antagonist

  • Developed in-house
  • SMP-986 possesses the dual pharmacological actions of muscarinic receptor antagonism (non-selective) and inhibition of the bladder afferent pathway through Na+-channel blockade. This compound is being evaluated for its ability to ease urinary urgency and reduce the frequency of both urination and incontinence. The compound has also exhibited the potential to have lower incidence of side effects related to muscarinic receptor antagonism, such as dry mouth.
  • Development stage: Phase II in the U.S. and Europe. Phase II in Japan

7 mar 2013

Dainippon Sumitomo Pharma Co., Ltd. (DSP) and Nippon Shinyaku Co., Ltd. Announce they have concluded a license agreement for exclusive rights to develop, manufacture and commercialize SMP-986 in Japan, a new therapeutic agent for overactive bladder created by DSP.

Completing Phase 2 studies in Japan…

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