Sprout Pharmaceuticals Appeals FDA Decision on NDA for Flibanserin to Treat Hypoactive Sexual Desire Disorder in Premenopausal Women

New Drug Approvals

Flibanserin, girosa
167933-07-5
 cas no

147359-76-0 (monoHCl)

Flibanserin, BIMT-17-BS, BIMT-17
1 – [2 – [4 – [3 – (Trifluoromethyl) phenyl] piperazin-1-yl] ethyl] -2,3-dihydro-1H-benzimidazol-2-one
1-[2-(4-(3-trifluoromethyl-phenyl)piperazin-1-yl)ethyl]-2,3-dihydro-1H-benzimidazol-2-one
C20-H21-F3-N4-O, 390.412, Boehringer Ingelheim (Originator)
  • Bimt 17
  • BIMT 17 BS
  • Bimt-17
  • Flibanserin
  • Girosa
  • UNII-37JK4STR6Z
Boehringer Ingelheim (Originator)
Antidepressants, Disorders of Sexual Function and Reproduction, Treatment of, ENDOCRINE DRUGS, Mood Disorders, Treatment of, PSYCHOPHARMACOLOGIC DRUGS, Treatment of Female Sexual Dysfunction, 5-HT1A Receptor Agonists, 5-HT2A Antagonists
Patents
EP 526434, JP 94509575, US 5576318, WO 9303016.
 WO2010/128516 , US2007/265276
Papers
Pharmaceutical Research, 2002 ,  vol. 19,  3,   pg. 345 – 349
Naunyn-Schmiedeberg’s Archives of Pharmacology, 1995 ,  vol. 352, 3  pg. 283 – 290
Journal of Pharmaceutical and Biomedical Analysis, v.57, 2012 Jan 5, p.104(5)
FLIBANSERIN
…………………….

December 11, 2013 – Sprout Pharmaceuticals today announced that it has received and appealed the Food and Drug Administration’s (FDA) Complete Response Letter (CRL) for flibanserin through the Formal Dispute Resolution process.

Flibanserin is an…

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ScinoPharma’s $113 million China API plant is ready to go

New Drug Approvals

Western drugmakers aren’t the only ones building new plants in China. Taiwan’s ScinoPharm has just finished up a $113 million facility to make active pharmaceutical ingredients (APIs) for China, as well as for export to the U.S. and Europe.

read all here

 

drill  animation

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Greener, cheaper, safer drugs and perfume using iron

Green Chemistry International

photo of perfume bottles on a tray
Researchers say iron can replace the rare and sometimes toxic compounds used to create perfumes and drugs (photo by Jenn Durfey via Flickr)

University of Toronto researchers have developed safer, cheaper and more environmentally-friendly techniques to produce compounds commonly used in drugs and perfumes.

Researchers used the  new techniques to create active, iron-based catalysts. These catalysts are needed to produce certain compounds used in the drug and perfume industries.  read all here

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CHYAVAN PRASH ; AN EXCELLENT AYURVEDA PREPARATION FOR ALL AGES TO BE TAKEN IN COLD SEASON

****आयुर्वेद : आयुष**** ई०टी०जी० आयुर्वेदास्कैन ****AYURVEDA : E.T.G. AyurvedaScan **** ****आयुष आविष्कार**** ई० एच० जी० ****होम्योपैथीस्कैन **** E.H.G. Homoeopathy Scan

CHYAVAN001
AYURVEDA, the Indian System of Medicine have full of hundreds of thousands of formulea and have almost a great hidden treasures of remedies for all ailing conditions. Among these formulea, CHARAK have mentioned an excellent combination of Herbs and food articles, which is used since centuries in India and in Indian continents.
charak001CHARAK SAMAHITA, the great Olden Book of CLASSICAL AYURVEDA PHILOSOPHY, THE INDIAN SYSTEM OF MEDICINE ; ORIGINALLY WRITTEN IN “SANSAKRIT LANGUAGE”,

CHYAVAN PRASH is one of them, widely used in all seasons , specially in Cold for maintaining Health and to protect from cold and cold exposure related anomalies.

Truely to say, CHYAVAN PRAS is a RASAYANA. Rasayan literally have wide means in AYURVEDA. To understand RASAYAN, one have to understand the SAPTA DHATU, which is a fundamental principles subject. SAPATA DHATU is considered equivalent to AYURVEDA PATHOLOGY.

charak001 001PAGES FROM CHARAK SAMAHITA MENTIONING THE FORMULA OF HERBS AND METHODS…

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Merck Statement on FDA Advisory Committee for GRASTEK® (Timothy Grass Pollen Allergen Extract), Merck’s Investigational Sublingual Allergy Immunotherapy Tablet

New Drug Approvals

pollen

An allergen is a type of antigen that produces an abnormally vigorous immune response in which the immune system fights off a perceived threat that would otherwise be harmless to the body. Such reactions are called allergies. In technical terms, an allergen is an antigen capable of stimulating a type-I hypersensitivity reaction in atopic individuals through Immunoglobulin E (IgE) responses.[1] Most humans mount significant Immunoglobulin E responses only as a defense against parasitic infections. However, some individuals may respond to many common environmental antigens. This hereditary predisposition is called atopy. In atopic individuals, non-parasitic antigens stimulate inappropriate IgE production, leading to type I hypersensitivity. Sensitivities vary widely from one person (or other animal) to another. A very broad range of substances can be allergens to sensitive individuals.

WHITEHOUSE STATION, N.J., Dec. 12, 2013–(BUSINESS WIRE)–Merck (NYSE:MRK), known as MSD outside the United States and Canada, today issued the following statement…

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The US Food and Drug Administration (FDA) has granted a six-month Priority Review designation to Genzyme’s New Drug Application (NDA) for Cerdelga (eliglustat)

New Drug Approvals

13 dec 2013

Genzyme’s Cerdelga NDA receives US FDA priority review designationpharmabiz.comThe US Food and Drug Administration (FDA) has granted a six-month Priority Review designation to Genzyme’s New Drug Application (NDA) for Cerdelga (eliglustat), an investigational oral therapy for adult patients with Gaucher disease

ELIGLUSTAT TARTRATE

THERAPEUTIC CLAIM Treatment of lysosomal storage disorders

CHEMICAL NAMES

1. Octanamide, N-[(1R,2R)-2-(2,3-dihydro-1,4-benzodioxin-6-yl)-2-hydroxy-1-(1-
pyrrolidinylmethyl)ethyl]-, (2R,3R)-2,3-dihydroxybutanedioate (2:1)

2. bis{N-[(1R,2R)-2-(2,3-dihydro-1,4-benzodioxin-6-yl)-2-hydroxy-1-(pyrrolidin-1-
ylmethyl)ethyl]octanamide} (2R,3R)-2,3-dihydroxybutanedioate

MOLECULAR FORMULA C23H36N2O4 . ½ C4H6O6

MOLECULAR WEIGHT 479.6

MANUFACTURER Genzyme Corp.

CODE DESIGNATION Genz-112638

CAS REGISTRY NUMBER 928659-70-5

old article cut paste

Genzyme Announces Positive New Data from Two Phase 3 Studies for Oral Eliglustat Tartrate for Gaucher Disease


Eliglustat tartrate (USAN)
CAS:928659-70-5
February 15, 2013
Genzyme , a Sanofi company (EURONEXT: SAN and NYSE: SNY), today announced positive new data from the Phase 3 ENGAGE and ENCORE studies of eliglustat tartrate, its investigational oral therapy for Gaucher disease type 1. The results from the ENGAGE study were…

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