FDA’s “Spotlight on Drug Innovation”-An ongoing update of novel new drug approvals in 2011

As an ongoing update, FDA has brought out a list of new molecular entities approved in 2011 under the project titled: "Spotlight on Drug Innovation".

So far in 2011, FDA has approved more than 150 new brand name and generic drug products. Many are duplicate therapies that will compete in the marketplace with the same kind of products already approved. 


But some are new and innovative chemical structures never used before in clinical practice. Novel new drugs are often called new molecular entities (NMEs). Many of these products offer new hope for patients suffering from the conditions these products are intended to treat.
  
Here is a glimpse of the NMEs approved in 2011...check it out!!

Drug Name	Active Ingredient	Date	What it’s used for
Datscan	ioflupane i-123	01/14	An imaging drug used to assist in the evaluation of adult patients with suspected Parkinsonian syndromes (PS).
Natroba	spinosad	01/18	For the treatment of head lice infestation in patients ages 4 years and older. Press Release
Viibryd	vilazodone hydrochloride	01/21	To treat major depressive disorder in adults. Press Release
Daliresp	roflumilast	02/28	To decrease the frequency of flare-ups (exacerbations) or worsening of symptoms from severe chronic obstructive pulmonary disease (COPD). Press Release
Edarbi	azilsartan medoxomil	02/25	To treat high blood pressure (hypertension) in adults. Press Release
Gadavist	gadobutrol	03/14	For use in patients undergoing magnetic resonance imaging (MRI) of the central nervous system. Press Release
Benlysta	belimumab	03/10	To treat patients with active, autoantibody-positive lupus (systemic lupus erythematosus) who are receiving standard therapy, including corticosteroids, antimalarials, immunosuppressives, and nonsteroidal anti-inflammatory drugs. Press Release
Yervoy	ipilimumab	3/25	To treat patients with late-stage (metastatic) melanoma, the most dangerous type of skin cancer. Press Release
Horizant	gabapentin enacarbil	04/06	A once-daily treatment for moderate-to-severe restless legs syndrome (RLS). Press Release
Vandetanib	vandetanib	04/06	To treat adult patients with late-stage (metastatic) medullary thyroid cancer who are ineligible for surgery and who have disease that is growing or causing symptoms. Press Release
Zytiga	abiraterone acetate	04/28	In combination with prednisone (a steroid) to treat patients with late-stage (metastatic) castration-resistant prostate cancer who have received prior docetaxel (chemotherapy). Press Release
Tradjenta	linagliptin	05/02	An adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Press Release
Victrelis	boceprevir	05/13	To treat certain adults with chronic hepatitis C. Press Release FDA Briefing on New Hepatitis C Drugs Consumer Information on Hepatitis B and C
Edurant	rilpivirine	05/20	For the treatment of HIV-1 infection in adults who have never taken HIV therapy. Press Release
Incivek	telaprevir	05/23	To treat certain adults with chronic hepatitis C infection. Press Release FDA Briefing on New Hepatitis C Drugs Consumer Information on Hepatitis B and C
Dificid	fidaxomicin	05/27	For the treatment of Clostridium difficile-associated diarrhea (CDAD). Press Release
Potiga	ezogabine	06/13	For use as an add-on medication to treat seizures associated with epilepsy in adults. Press Release

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Nulojix (Belatacept) approved by FDA, BMS on a roll after back to back success!!

A  little more than a year after the FDA decided to take a wait-and-see approach on Bristol-Myers Squibb's Nulojix (belatacept), federal regulators have finally blessed the marketing application for the drug, which is expected to offer a better way to prevent the rejection of newly transplanted kidneys.

That represents another solid regulatory win for BMS, which recently won federal approval of Yervoy (ipilimumab) for skin cancer. With an R&D budget last year of little more than $3.5 billion, BMS has had more approvals this year than several biopharma companies well known for spending far more than that. The official OK also marks a surge in new drug approvals at the FDA this year.

BMS's application for the drug hit a snag at the FDA last year after regulators asked for additional follow-up data from late-stage trials and raised an issue with problems found at the Puerto Rican manufacturing plant where the treatment will be made. Once the regulators waved a green flag on the manufacturing site, an approval was virtually assured.

Nulojix is a type of drug called a selective T-cell costimulation blocker. The drug helps to prevent organ rejection after a kidney transplant.

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Daniel Kraft: Medicine's future? There's an app for that | Video on TED.com

Daniel Kraft offers a fast-paced look at the next few years of innovations in medicine, powered by new tools, tests and apps that bring diagnostic information right to the patient's bedside.


A Must Watch!!

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Potiga (ezogabine) Receives FDA Approval

Valeant Pharmaceuticals International Inc.(Meda’s partner for ezogabine - known as retigabine outside of the U.S.) has received approval from the U.S.FDA for Potiga(ezogabine).

Potiga is approved for adjunctive treatment for adults with partial-onset seizures. It is the first approved potassium channel opener for this indication.

                                                            Retigabine (INN) or ezogabine (USAN)

The efficacy of ezogabine as adjunctive therapy in partial onset seizures was established in 3 controlled clinical studies involving 1,239 adult patients.

The primary endpoint was percent change in seizure frequency from baseline in the double-blind treatment phase.

Outside of the U.S., ezogabine is known as retigabine (brand name Trobalt), and received marketing authorization in the European Union (EU) on March 28th 2011.

Valeant and GSK had been working on the drug jointly and this drug is believed to play a needed role in the management of partial onset seizures in patients who are uncontrolled on their current medications.

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Teva beats Valeant to grab Cephalon

Teva Pharmaceutical Industries has swooped in to grab Cephalon away from prospective buyer Valeant Pharmaceuticals. The Israel-based generics giant has agreed to pay $6.8 billion  for Cephalon, best known for its sleep-disorder drugs Provigil and Nuvigil. The $81.50-per-share offer beats Valeant's $73 hostile bid by almost 12 percent.

Cephalon's pain, sleep and cancer drugs will help Teva reduce its reliance on the big-selling Copaxone(a Multiple Sclerosis drug), which faces increasing competitive threats.

As Bloomberg notes, with Cephalon's drugs, Teva would boast $7 billion a year in branded sales. The company would also have two blockbusters to its credit, Copaxone and Cephalon's Provigil.

The Israeli company has been buying up companies and products as part of its long-term strategy to be a $31 billion company by 2015.

Cephalon marks the third major deal for Teva after previous purchases of Barr Pharmaceuticals and Ratiopharm (germany), thus becoming the biggest generics maker in Europe.

Teva pharmaceuticals is the largest generic drug manufacturer in the world and one of the 15 largest pharmaceutical companies worldwide.In 2008, sales totalled $11.08 billion, $13.9 billion in 2009, and in 2010 total sales rose to $16.1 billion, of which a major portion was in Europe and North America.

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NIPER JEE 2011 - Important updates

New Update:
Get your Admit Card from here:


http://119.226.214.30/NIPER/NIPER-HALLTICKETS-JULY2011/


If it is not accesible, try this:


http://www.niper.nic.in/niperjee2011.html

General Instructions:

Details of eligibility, qualifications, availability of programmes, admission  procedure and other relevant information is available in the Information Brochure (will be available on the website http://www.niper.ac.in/niperjee2011.html. 

Reservation of seats for SC/ST/OBC/PH and Kashmiri Migrants candidates will be as per Government of India norms.  

Candidates appearing for final qualifying examinations can also apply but they must produce final result on the day of Counselling/Interview/GD, failing which their candidature shall be rejected.

Candidate shall fill the registration form online by registering on www.niper.ac.in/niperjee2011.html. The process of online registration shall commence on 1st June 2011 and will continue till 15th June 2011. 

Candidate shall have to fill up all items given in online registration form (including no. and date of Demand Draft for Rs. 1000), upload softcopy of recent photograph, submit form and take printout of the registration slip (incomplete forms or forms which are not properly submitted will not be accepted), put signatures at the bottom of the registration slip and attach  following:

 i) a non refundable Demand Draft of Rs. 1000/-(Rs.500/- for SC/ST) payable at S.A.S. Nagar (Mohali)/Chandigarh in favour of “NIPER JEE-2011”.

 ii) Copy of the award letter (if any) pertaining to GATE/GPAT/NET etc.

 iii) Sponsorship certificate from industry/government sponsored candidates (format given at Annexure-2 in information brochure).

•  Indian nationals residing abroad and foreign nationals have to remit US$100 by Bank Draft payable to “NIPER JEE-2011”. Payment by Cheque/Postal Order will not be accepted. 

•  Candidates will have to make their own arrangements for travel and boarding for attending written test, GD & interview and counseling.

•  Registration  slip  with attachments  should  be  sent  to Registrar, National Institute of Pharmaceutical Education and  Research, (NIPER), Sector 67,  S.A.S.Nagar  (Mohali),  Punjab,  160062, (through speed post/registered post) so as to reach him on or before 22nd June 2011. 

•  NIPER-Joint Entrance Examination 2011 (for  all disciplines  of the  Masters  programme)  will be held on Sunday, the 3rd July , 2011 at Ahmedabad, Bangalore,       Chandigarh, Delhi, Hyderabad, Jaipur, Kolkata, Lucknow, Mumbai, Nagpur, Pune and Trivandrum. The centres may be altered if sufficient numbers of candidates do not register for a particular centre.

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NIPER JEE 2011 - IMPORTANT DATES

Particulars	Dates
Notification of admission	15th April, 2011
Date of commencement of online registration	1st June 2011
Last date for online registration	15th June, 2011
Last date of receipt of filled registration form alongwith demand draft	22nd June, 2011
Date for receiving admit card by e-mail	30th June, 2011
NIPER Joint Entrance Examination (10.00 AM to 12.00 noon)	3rd July, 2011
Declaration of result of written test (website-www.niper.gov.in/niperjee2011.html)	7th July, 2011
Group Discussion and Interview of M.B.A. (Pharm.)	12-13th July, 2011
Declaration of the list of selected candidates and admission to M.B.A. (Pharm.)	14th July, 2011
Declaration of the waitlisted candidates and admission to M.B.A. (Pharm.). Candidates shall report at 10:00 a.m. and those who fail to report in time shall be declared absent and not considered for admission. Admission shall close at 10:30 a.m.	15th July, 2011
NIPER Joint Counselling for admission to Masters Programmes	20-22nd July, 2011
Orientation	29th July, 2011
Commencement of classes	1st August, 2011

Insitues an Courses

Institutes	Available disciplines
NIPER, Ahmedabad	Biotechnology, Medicinal Chemistry, Natural Products, Pharmaceutical Analysis, Pharmaceutics, Pharmacology & Toxicology
NIPER, Guwahati	Biotechnology, Pharmacology & Toxicology, Pharmacy Practice
NIPER, Hajipur	Biotechnology, Pharmacoinformatics, Pharmacy Practice
NIPER, Hyderabad	Medicinal Chemistry, Pharmaceutical Analysis, Pharmaceutics, Pharmacology & Toxicology
NIPER, Kolkata	Medicinal Chemistry, Natural Products, Pharmacoinformatics
NIPER, Rae Barelli	Medicinal Chemistry , Pharmaceutics
NIPER, S.A.S. Nagar	Biotechnology, Medicinal Chemistry, Natural Products, Pharmaceutical Analysis, Pharmaceutical Management, Pharmaceutical Technology (Biotechnology), Pharmaceutical Technology (Process Chemistry)*, Pharmaceutical Technology (Formulations), Pharmaceutics, Pharmacoinformatics, Pharmacology & Toxicology, Pharmacy Practice, Clinical Research, Regulatory Toxicology, Traditional Medicine

 * Earlier this discipline was named as Pharmaceutical Technology (Bulk Drugs)

Eligibility-     (A) M.S. (Pharm.); M.Pharm. ; M.Tech. (Pharm.)

Discipline	Programme	Eligibility for Application
Biotechnology	M.S.(Pharm.)	B.Pharm./M.Sc.(Biological Sciences)
Medicinal Chemistry	M.S. (Pharm.)	B.Pharm./M.Sc.(Organic Chemistry)
Natural Products	M.S. (Pharm.)	B.Pharm./M.Sc.(Organic Chemistry)
Pharmaceutical Analysis	M.S. (Pharm.)	B.Pharm./M.Sc.(Organic/ Analytical Chemistry)
Pharmaceutical Technology (Biotechnology)	M.Tech. (Pharm.)	B.Pharm./M.Sc.(Life Sciences)
Pharmaceutical Technology (Process Chemistry) *	M.Tech. (Pharm.)	B.Pharm./M.Sc.(Organic Chemistry)/B.Tech. (Chemical Engg. or equivalent)
Pharmaceutical Technology (Formulations)	M.Pharm.	B.Pharm.
Pharmaceutics	M.S.(Pharm.)	B. Pharm.
Pharmacoinformatics	M.S. (Pharm.)	B.Pharm./M.Sc.(Organic/Physical/Pharmaceutical Chemistry)/M.Sc./B.Tech. (Bioinformatics)/M.Sc. (Biochemistry/Biotechnology/Molecular Biology/ Microbiology)
Pharmacology & Toxicology	M.S. (Pharm.)	B.Pharm./B.V.Sc./M.B.B.S.
Pharmacy Practice	M.Pharm.	B. Pharm.
Clinical Research	M.Pharm.	B. Pharm.
Regulatory Toxicology	M.S. (Pharm.)	B.Pharm./B.V.Sc./M.Sc.(Pharmacology/Toxicology/Life Sciences/Biochemistry/Medical Biotechnology/ Zoology)/M.B.B.S.
Traditional Medicines	M.S. (Pharm.)	B.Pharm./B.A.M.S./M.Sc.(Botany)

* Earlier this discipline was named as Pharmaceutical Technology (Bulk Drugs)

Eligibility-     (B) M.B.A. (Pharm.)

Pharmaceutical Management

M.B.A.(Pharm.)

B.Pharm./B.Tech.(Chemical Engg. or equivalent)/ M.Sc. (Chemical / Life Sciences)

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LOOPHOLES IN HATCH WAXMAN ACT

The Drug Price Competition and Patent Term Restoration Act, informally known as the "Hatch-Waxman Act", is a 1984 United States federal law which established the modern system of generic drugs. The informal name comes from the Act's two sponsors, representative Henry Waxman of California and senator Orrin Hatch of Utah.

Hatch-Waxman amended the Federal Food, Drug, and Cosmetic Act.as a result of which the would-be marketers of generic drugs can file Abbreviated New Drug Applications (ANDAs) to seek FDA approval of the generic. 

Although it has been a boon for the small players in the market and saved people from emptying their bank accounts fully......there are some loopholes which we cannot just ignore!! They require some action to be taken and the FDA needs to amend the act to prevent the discrepancies observed today......"

The major loopholes in the act which have been explored by the brand name manufacturers to gather full advantage are:

1. Warehousing patents and frivolous lawsuits:

The Buspar case (BMS vs Mylan Pharmaceuticals) relates to both the Para III and Para IV certifications.

Bristol Mayer Squibb (BMS) Co had patent number 4182763 with a primary claim of buspirone as an anxiolytic agent. This patent expired on July 21, 2000, and Mylan Pharmaceuticals filed a Para III certification and obtained a tentative approval to market the generic version of the drug not before July 22, 2000.

However, BMS obtained another patent  just 12 hours before the expiry of its first (763) patent claiming the active metabolite of buspirone as responsible for the anxiolytic effect.

The patent was for the combination of the chemical compound in the drug with stomach acid which was produced naturally.

The patent was listed in the Orange Book and as per the laws was informed to Mylan that the ANDA was incomplete and needed justification that its generic version of buspirone would not infringe upon the new patent.

Mylan in anticipation filed a Para IV certification under the Hatch Waxman Act which led to the patent infringement lawsuit against Mylan immediately halting the final market approval of the generic and the associated stays and delays.

FDA could not approve the marketing of the generic that Mylan had already loaded on trucks for shipment.

It is also referred to as Evergreening or Warehousing of patents. An innovator may patent multiple attributes of a product (may be color, manufacturing process or the chemicals produced when the drug is ingested in the body) and keeps on adding patents in the Orange Book, essentially forcing the generic to hose between waiting for the patents to expire or file a Para IV certification which brings along the risks of litigation and associated costs and delays.

The provision of filing a patent infringement lawsuit gives the brand name manufacturer at least an additional two and a half years of product monopoly has resulted in a wave of such lawsuits.

2. Maneuvering the six month Generic Exclusivity

The practices commonly referred to as ‘Sweetheart deals’ allow the first generic manufacturer and the innovator to enter into an agreement and to have a control when to introduce the generic.

This would not trigger the 180 days generic exclusivity period offered to the first generic and the FDA is bound not to approve another generic until the 180 day generic exclusivity period perishes.

This will suspend the competition for an indefinite period of time. This extended brand name monopoly allows the brand name and the generic manufacturer to share the financial awards keeping other generic competitors in an indeterminate state.

Case study:-

Cardizem CD (diltiazem hydrochloride) is a prescription drug manufactured by Hoechst-Marion Roussel, Inc. (“HMRI”) that is used to treat angina and hypertension.

The Cardizem litigation arises primarily out of an interim “settlement” of patent infringement litigation brought by HMRI against Andrx Pharmaceuticals, Inc., the first ANDA filer for Cardizem CD.

In settling the patent infringement litigation, HMRI and Andrx allegedly agreed that, beginning upon final FDA approval of Andrx’s generic product, HMRI would pay Andrx $10 million per quarter not to enter the market with its generic product until the conclusion of the patent litigation.

The intention of this article is to bring to notice the exploitation of the loopholes of Hatch Waxman Act by several multinational companies. This in turn affects the common people as the generic products could not enter the market early and deprives them of the monetary relief (which they would be enjoying with generics). Its time to take action.....USFDA!!

( Several more cases have been observed.refer other cases from: Saigal N. et al, USFDA Generic Approval Process,Indian J.Pharm. Educ. Res.; Jul-Sept, 2009:232-238. available from the internet at:http://www.ijperonline.com/archives/IJPER_43_3_2009.pdf)

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The Generic Drug Approval Process- made easy

For a better understanding of the generic drug approval, one must be clear about the drug development process. Once a new compound has been identified in the laboratory,it undergoes the drug development process before it can be marketed for public use.

The entire drug development process can be summarized in a series of steps:

Drug Development Steps:

• PreclinicalTesting
• Investigational New Drug Application (IND).
• Clinical Trials
• New Drug Application(NDA)
• Approval

Investigational New Drug Application (IND)

After completing preclinical testing, a company files an IND with the U .S. Food and Drug Administration (FDA) to begin to test the drug in people. The IND application is the result of a successful preclinical development program. The IND is also the vehicle through which the innovator advances to the next stage of drug development known as clinical trials (human trials) . 

New Drug Application (NDA)

Following thecompletion of all three phases of clinical trials, a company analyzes all of the data and files an NDA with FDA if the data successfully demonstrate both safety and effectiveness.

The NDA contains all of the scientific information that the company has gathered. NDAs typically run 1 00,000 pages or more. By law, FDA is allowed six months to review an NDA.

Approval

Once FDA approves an NDA, the new medicine becomes available for physicians to prescribe. A company must continue to submit periodic reports to FDA, including any cases of adverse reactions and appropriate quality-control records. For some medicines,FDA requires additional trials (Phase IV) to evaluate long-term effects.

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A Pharmacist

Who is a pharmacist?

I came across some definitions which are really interesting....

check it out...

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