Brazil: Overview of API registration

Regulatory Affairs in Latin America

In Brazil, the health authority (ANVISA) will require that all Active Pharmaceutical Ingredients (APIs) manufactured in Brazil, imported for manufacturing of drug products, or included in imported finished products, are registered with the agency.

This regulation has been put in place in 2009, and the implementation has been gradual: ANVISA created a scheme that includes the different API categories in different “waves” of implementation.

In the first implementation wave (deadlines to register in 2010) the following drug substances were included: Cyclosporine, Clozapine, Clindamycin Chlorhydrate, Ciclophosphamide, Ciprofloxacin, Methotrexate, Carbamazepine, Lithium Carbonate, Phenytoin, Sodium Phenytoin, Lamivudine, Penicillamine, Thiabendazole, Efavirenz, Nevirapine, Rifampicin, Ritonavir, Zidovudine, Acyclovir and Ampicillin.

In June 2013, the second implementation wave was announced, including the following substances: Azithromycin, Benzylpenicillin, Cabergoline, Carboplatin, Cephalexin, Cephalothin, Ceftazidime, Cisplatin, Clarithromycin, Ceftriaxone and their respective salts, esters, ethers and hydrates, and the salts, esters, ethers and hydrates of the APIs included in the first…

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Bristol-Myers Squibb announced promising results from an expanded phase 1 dose-ranging study of its lung cancer drug nivolumab

New Drug Approvals

NIVOLUMAB

Anti-PD-1;BMS-936558; ONO-4538

PRONUNCIATION nye vol’ ue mab
THERAPEUTIC CLAIM Treatment of cancer
CHEMICAL DESCRIPTION
A fully human IgG4 antibody blocking the programmed cell death-1 receptor (Medarex/Ono Pharmaceuticals/Bristol-Myers Squibb)
MOLECULAR FORMULA C6362H9862N1712O1995S42
MOLECULAR WEIGHT 143.6 kDa

SPONSOR Bristol-Myers Squibb
CODE DESIGNATION MDX-1106, BMS-936558
CAS REGISTRY NUMBER 946414-94-4

Bristol-Myers Squibb announced promising results from an expanded phase 1 dose-ranging study of its lung cancer drug nivolumab

Nivolumab (nye vol’ ue mab) is a fully human IgG4 monoclonal antibody designed for the treatment of cancer. Nivolumab was developed by Bristol-Myers Squibb and is also known as BMS-936558 and MDX1106.^[1] Nivolumab acts as an immunomodulator by blocking ligand activation of the Programmed cell death 1 receptor.

A Phase 1 clinical trial^[2] tested nivolumab at doses ranging from 0.1 to 10.0 mg per kilogram of body weight, every 2 weeks. Response was assessed after each 8-week treatment cycle, and were evaluable…

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FDA In India: Going Global, Coming Home, Altaf Ahmed Lal, Ph.D. is the Director of FDA’s office in India.

New Drug Approvals

 

Altaf Ahmed Lal, Ph.D. is the Director of FDA’s office in India.

http://blogs.fda.gov/fdavoice/index.php/2013/09/fda-in-india-going-global-coming-home/

Posted on September 24, 2013 by FDA Voice

By: Altaf Ahmed Lal, Ph.D. 

What is it like to be starting my new position as director of FDA’s office in India?

It’s like coming home.

http://blogs.fda.gov/fdavoice/index.php/2013/09/fda-in-india-going-global-coming-home/

My new tenure at FDA began in June, but as a former health attaché in the U.S. Embassy, I played an enthusiastic role in helping to establish FDA in my native country.  I was born in Kashmir, India, and though I left the country in 1980 to explore new professional opportunities in the United States, I have since been drawn back again and again.

http://blogs.fda.gov/fdavoice/index.php/2013/09/fda-in-india-going-global-coming-home/

 

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Founder of leading Indian pharmaceutical company, Sun Pharmaceuticals has been named India’s third richest man

New Drug Approvals

This is the first time Mr Dilip Shanghvi, founder of Sun Pharmaceutical has been named in the top three with a 66 percent surge in his wealth –

25 oct 2013

Singapore: For the first time, founder of leading Indian drugmaker Sun Pharmaceuticals, Mr Dilip Shanghvi has been named in the top three of India’s richest men. Mr Shanghvi has made an appearance in the list prepared by China based ‘Hurun India Rich List’ as the third richest Indian man with a 66 percent surge in his wealth. Energy tycoon and Reliance Industries chairman Mr Mukesh Ambani has topped the list as India’s richest man with personal assets of $18.9 billion, news reports mentioned. The report pointed out that Mr Ambani has retained the top position for the second year even after a wealth decrease of two percent. London-based steel baron Mr Lakshmi Narayan Mittal has been named the second…

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FDA approves second brain imaging drug Vizamyl (flutemetamol F 18 injection)to help evaluate patients for Alzheimer’s disease, dementia

New Drug Approvals

  is the structure on right

Vizamyl (flutemetamol F 18 injection)

http://jnm.snmjournals.org/content/50/8/1251/F1.expansion.html get structure

 

Chemical name:	2-{3-[18F]fluoro-4-(methylamino)phenyl}-1,3-benzothiazol-6-ol    diagnostic aid
Cas Number	765922-62-1
INN  name	flutemetamol
Molecular Formula:

GE Healthcare

FDA PRESS RELEASE

For Immediate Release: Oct. 25, 2013

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm372261.htm

The U.S. Food and Drug Administration today approved Vizamyl (flutemetamol F 18 injection), a radioactive diagnostic drug for use with positron emission tomography (PET) imaging of the brain in adults being evaluated for Alzheimer’s disease (AD) and dementia.

Dementia is associated with diminishing brain functions such as memory, judgment, language and complex motor skills. The dementia caused by AD is associated with the accumulation in the brain of an abnormal protein called beta amyloid and damage or death of brain cells. However, beta amyloid can also be found in the brain of patients with other dementias and in elderly people without neurologic disease.

Vizamyl works by attaching to beta amyloid…

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loteprednol etabonate…Patent expiry this week……of October 20, 2013

New Drug Approvals

loteprednol etabonate

82034-46-6 cas

Drug Patent Expiry for the week of October 20, 2013

Tradename….LOTEMAX

Applicant………Pharmos

SUSPENSION/DROPS; OPHTHALMIC, o.5%

Generic Name………loteprednol etabonate

Patent No.US 5,540,930

http://www.google.co.in/patents/US5540930

The invention provides novel compositions of matter containing water-insoluble steroid drugs suitable for therapeutic use. The invention provides stable aqueous suspensions of water-insoluble steroid drugs of particle sizes of ≦15 μm which remain in such a state so as to allow for immediate suspension, when desired, even after extended periods of settling.

Approval History

Date	Supplement No.	Action	Documents
1998-03-09	000	Approval	Review Letter Label

Publication number	US5540930 A
Publication type	Grant
Application number	US 08/142,743
Publication date	30 Jul 1996
Filing date	25 Oct 1993
Priority date	25 Oct 1993
Fee status	Paid
Also published as	CA2174550A1, CA2174550C, DE69430635D1, DE69430635T2, EP0730443A1, EP0730443A4, EP0730443B1, US5747061, WO1995011669A1, Less «8 More »
Publication number

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FDA Generic Presentation

FDA Generic Presentation from gvanantwerp

Preparing an IND Application

<div style=”margin-bottom:5px”> <strong> <a href=”https://www.slideshare.net/webgoddesscathy/preparing-an-ind-application-cmc&#8221; title=”Preparing an IND Application: CMC” target=”_blank”>Preparing an IND Application: CMC</a> </strong> from <strong><a href=”http://www.slideshare.net/webgoddesscathy&#8221; target=”_blank”>MaRS Discovery District</a></strong> </div>

What is a medical device?

October 14 ,2013 | By Anabela Farrica

Health technologies can be divided in two main categories: medicines and medical devices. A lot has already been said and written about medicines, but medical devices seem to be out of the public eye most of the time. As a consequence, many raise the question: what is, in reality, a medical device?

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VERCIRNON – GSK1605786A (formerly CCX282-B) Anti-inflammatory intended to treat Crohn’s disease and inflammatory bowel disease

New Drug Approvals

http://www.ama-assn.org/resources/doc/usan/vercirnon.pdf

vercirnon
Trade Name:	Traficet-EN
Synonym:	CCX282-B, GSK1605786, GSK 1605786

• C₂₂H₂₁ClN₂O₄S
• Average mass: 444.931091

4-(2-(4-(tert-butyl)phenylsulfonamido)-5-chlorobenzoyl)pyridine 1-oxide

698394-73-9 [RN]

Anti-inflammatory intended to treat Crohn’s
disease and inflammatory bowel disease

GSK1605786A (formerly CCX282-B) targets chemokine receptor CCR9, which is expressed selectively on intestinal lymphocytes and dendritic cells. CCR9 mediates migration of immune cells to the intestine, and blockade of the receptor inhibits migration.

GSK1605786A is being studied in CD at a dose of 500 mg by mouth once daily or 500 mg by mouth twice daily versus placebo. Final data is anticipated to be collected mid-2012 for a study evaluating efficacy over a 12-week treatment period.

A study reviewing maintenance of remission is expected to be complete in July 2014 and a long-term safety study is scheduled for completion in July 2015.

GSK-1605786 (CCX-282; Traficet-EN), a selective antagonist of the CC chemokine receptor (CCR9)…

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Glaxo Plans to File for Malaria Vaccine Approval Next Year

New Drug Approvals

Malaria vaccine candidate reduces disease over 18 months of follow-up in late-stage study of more than 15,000 infants and young children

Malaria is a significant public health burden, claiming 660,000 lives a year – mostly children in sub-Saharan Africa
-Data support plan to submit regulatory application in 2014

Multilateral Initiative on Malaria Pan African Conference, Durban, South Africa — Results from a large-scale Phase III trial, presented today in Durban, show that the most clinically advanced malaria vaccine candidate, RTS,S, continued to protect young children and infants from clinical malaria up to 18 months after vaccination. Based on these data, GSK now intends to submit, in 2014, a regulatory application to the European Medicines Agency (EMA). The World Health Organization (WHO) has indicated that a policy recommendation for the RTS,S malaria vaccine candidate is possible as early as 2015 if it is granted a positive scientific opinion by EMA.

READ…

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GSK and Genmab seek alternative approval for leukaemia drug Arzerra

New Drug Approvals

Arzerra

GlaxoSmithKline and Genmab A/S have announced the submission of leukaemia drug Arzerra to the European Medicines Agency (EMA) for a variation in marketing authorisation.

The companies are seeking authorisation for the drug to be used in combination with an alkylator-based therapy for treatment of Chronic Lymphocytic Leukemia (CLL) patients who have not received prior treatment and are inappropriate for fludarabine-based therapy.

READ ALL AT

http://www.pharmaceutical-technology.com/news/newsgsk-and-genmab-seek-alternative-approval-leukaemia-drug-arzerra?WT.mc_id=DN_News

Ofatumumab(trade name Arzerra, also known as HuMax-CD20) is a humanmonoclonal antibody (for the CD20 protein) which appears to inhibit early-stage B lymphocyte activation. It is FDA approved for treating chronic lymphocytic leukemia that is refractory to fludarabine and alemtuzumab (Campath) and has also shown potential in treating Follicular non-Hodgkin’s lymphoma, Diffuse large B cell lymphoma, rheumatoid arthritis and relapsing remitting multiple sclerosis. Ofatumumab has also received conditional approval in Europe for the treatment of refractory chronic lymphocytic leukemia…

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