MARCH-APRIL-MAY 2015 US-FDA APPROVED DRUGS

                             MARCH-APRIL-MAY 2015 US-FDA APPROVED DRUGS

                                          MARCH 2015 US-FDA APPROVED DRUGS

1. TRADE (BRAND) NAME- Cresemba
ACTIVE PHARMACEUTICAL INGREDIENT- Isavuconazonium sulfate
COMPANY NAME- Astellas
USE- Isavuconazonium sulfate is a prodrug of 'isavuconazole' which is a triazole anti-fungal drug. It inhibits lanosterol 14-alpha demethylase-an enzyme which is responsible for the conversion of lanosterol to ergosterol- the building block for fungal cell walls. It is approved for the treatment of invasive aspergillosis (a fungal infection which mostly affects lungs and usually occurs with patients with tuberculosis and chronic obstructive pulmonary disorders-COPD) and invasive mucormycosis (a fungal infection mainly affecting the lungs, sinuses and brain).

                                                   ISAVUCONAZONIUM SULFATE

2. TRADE (BRAND) NAME- Cholbam
ACTIVE PHARMACEUTICAL INGREDIENT- Cholic acid
COMPANY NAME- Asklepion Pharmaceuticals
USE- Cholic acid is one of the major bile acids which is produced in the liver of human body from cholesterol. It decreases the effectiveness or downregulation of cholesterol-7-alpha hydrolase - a rate limiting step of bile acid synthesis. Cholbam capsules are approved for the treatment of bile acid synthesis disorders as well as peroxisomal disorders.

                                                               CHOLIC ACID   
                      
3. TRADE (BRAND) NAME- Opdivo
ACTIVE PHARMACEUTICAL INGREDIENT- Nivolumab
COMPANY NAME- Bristol-Myers Squibb
USE- Nivolumab is a humanized whole IgG 4 anti- PD 1 (programmed cell death receptor) monoclonal antibody which acts as an immunomodulator by blocking ligand activation of PD-1 receptor on activated T-cells. It is approved for the use of metastatic melanoma, squamous non-small cell ling cancer and Hodgkin's lymphoma.

4. TRADE (BRAND) NAME- Unituxin
ACTIVE PHARMACEUTICAL INGREDIENT- Dinutuximab
COMPANY NAME- United Therapeutics
USE- Dinutuximab is a chimeric (human/mouse) monoclonal antibody developed for the pediatrics with high-risk neuroblastoma.



                                            APRIL 2015 US-FDA APPROVED DRUGS

1. TRADE (BRAND) NAME- Kybella
ACTIVE PHARMACEUTICAL INGREDIENT- Deoxycholic acid
COMPANY NAME- Kythera Biopharma
USE- Deoxycholic acid is one of the secondary bile acid which is the metabolic by-products of intestinal bacterial. It is used in the emulsification of fats for the absorption of intestine. It is used for destroying the moderate to high amount of fat below the chin in the submental triangle.

                                                       DEOXYCHOLIC ACID


2. TRADE (BRAND) NAME- Corlanor
ACTIVE PHARMACEUTICAL INGREDIENT- Ivabradine
COMPANY NAME- Amgen
USE- Ivabradine is a cardiotonic agent, anti-anginal agent whose mechanism differs the usual anti-anginal drugs like beta blockers, calcium channel blockers. It blocks the "funny" ion current which is highly active in the sinoatrial node. "Funny" ion current is a mixed sodium-potassium inward current activated by hyperpolarization. Thus, by blocking this ion current it slows the heart rate and reduces cardiac pace-maker activity. It is approved for the treatment of chronic heart failure.

IVABRADINE

                                                MAY 2015 US-FDA APPROVED DRUGS

1. TRADE (BRAND) NAME- Viberzi

ACTIVE PHARMACEUTICAL INGREDIENT- Eluxadoline
COMPANY NAME- Actavis
USE- Eluxadoline is a mu- and kappa- opioid receptor agonist and delta- receptor antagonist. It is a novel orally-acting drug acts locally on enteric nervous system and thus decreasing the adverse effects on central nervous system. It is approved for the treatment of irritable bovel syndrome (IBS) with diarrhea and abdominal pain.

                                                                 ELUXADOLINE

2. TRADE (BRAND) NAME- Xifaxan
ACTIVE PHARMACEUTICAL INGREDIENT- Rifaximin
COMPANY NAME- Salix Pharmaceuticals
USE- Rifaximin is a semi-synthetic antibiotic based on rifamycin. It is also approved for the treatment of IBS and thus relieving bloating and flatulence associated with it. Rifaximin binds to the beta subunit of bacterial RNA-polymerase and thus blocking translocation step, inhibiting transcription.

                                                                       RIFAXIMIN

3. TRADE (BRAND) NAME- Stiolto Respimat
ACTIVE PHARMACEUTICAL INGREDIENT- Tiotropium bromide and Olodaterol
COMPANY NAME- Boehringer Ingelheim
USE- Tiotropium bromide is a long acting anticholinergic (muscarinic receptor antagonist) bronchodilator used for the maintainance of COPD which includes chronic bronchitis and emphysema.
Olodaterol is a long acting beta-adrenoreceptor agonist used for the maintainance of COPD including chronic bronchitis and emphysema.

                                                              TIOTROPIUM BROMIDE

                                                                      OLODATEROL

NIPER-JEE STUDY PREPARATION TIPS

                                       NIPER-JEE PREPARATION STUDY TIPS
            National Institute of Pharmaceutical Education and Research (NIPER) is the first national level institute in pharmaceutical sciences with an objective of becoming a centre of excellence for advanced studies and research in the same field. The Government of India has declared it as an 'Institute of National Importance' and is an autonomous body set up under the Department of Pharmaceuticals, Ministry of Chemicals and Fertilizers, Government of India. It offers PG and Ph.D courses under various disciplines such as Pharmaceutical Medicinal Chemistry, Pharmaceutics, Pharmacology, Pharmaceutical Analysis, Pharmaceutical Biotechnology, Toxicology, Clinical Research, Traditional Medicines, Natural Products, Pharmacy Practice, Pharmacoinformatics and MBA (Pharmacy). PG courses include M.S (Pharm), M.Pharm courses in the above areas as well as M.Tech in Pharmaceutical Technology in fields such as Pharmaceutical Biotechnology, Process chemistry and Formulations Technology. NIPERs are located currently at 7 places in India such as
1. Chandigarh or Mohali (S.A.S Nagar)- 1st NIPER to be established in late 1990s,
2. Ahmedabad (Gujarat)
3. Hajipur (Bihar)
4. Kolkata (West Bengal)
5. Rae Bareli (Uttar Pradesh)
6. Guwahati (Assam)
7. Hyderabad (Telangana)
 For more further information you can refer www.niper.gov.in and to respective websites of these 7 NIPER schools.
             NIPER-JEE is a 200 question paper and a paper-pen exam wherein you have to darken the circles on the answer sheet or ORS (Objective Response Sheet) for the correct option/ answer with a duration of 2 hours. Like GPAT, 25% deduction in marks in case of wrong answer is also applicable in NIPER-JEE. Only GPAT/GATE qualified candidates are eligible for appearing in NIPER-JEE exam. There is no as such a well-defined syllabus for NIPER-JEE. So the questions which can be asked are slightly unpredictable. But the general trend of the examination is more or less set and with the below tips you might be able to crack NIPER-JEE with flying colors.

STUDY TIPS-
1. Take your watch along with you at the examination hall. Since you have to solve 200 questions from 2 hours, try to plan your work of solving questions. If you calculate, you have just 36 seconds to solve 1 question. So try to set smaller targets such as solving 25 questions in each 15 minutes of 2 hours. If you strictly follow it, then there is a much greater chance of solving the paper in time. At the end of 15 minutes, if you observe that you are unable to solve the target of 25 questions, leave the remaining questions and move on to next question which is a multiple of 25. Later on if you have time left with you then you can have a look on the questions which were left before. Going through all the 200 questions is very much important since you never know, easy questions may be at the back-end of the question paper like from say 170 / 180 to 200.
PERSONAL EXPERIENCE- In my NIPER-JEE 2014 question paper, questions from 180 to 200 were very easy and due to my planning I was able to have a glance of all 200 questions and was thus able to attempt 140-150 questions.

2. Make your GPAT preparation strong enough. This acts as the base for your NIPER-JEE preparation. If you are very thorough with the core pharma subjects, then your preparation for NIPER-JEE is half done. Make your basics about pharmacy knowledge very clear from subjects like Physical Pharmacy, Pharmaceutical Engineering, Pharmaceutics, Pharmacognosy, Pharmaceutical Analysis, Pharmacology etc.

3. A lot of questions are asked on subjects like Biochemistry, Microbiology, Biotechnology, Genetic Engineering, Molecular Biology. Almost 40-50 questions comes from these areas. So don't neglect these subjects although they are neglected during GPAT preparation.
If you are preparing for your ICT-BPT entrance exam too along with NIPER-JEE, then your preparation for NIPER-JEE becomes a whole lot easier because up to 60% questions in ICT-BPT entrance exam comes from those above subjects (Refer ICT-BPT entrance exam syllabus to get an idea).

4. 5-10 questions have been regularly asked on Novel Drug Delivery Systems (NDDS), name of polymers used in formulation, their basic structure etc.

5. About 8-10 questions are asked on basics of organic chemistry, name reactions and stereochemistry.

6. Approximately 5-10 questions are compulsorily asked based on
a.General Knowledge,
b. Current affairs of the country,
c. Business and Trade Acts & Rules ,
d.Patents and trade treaties like GATT, WTO etc.,
e.statistics,
f. recent US-FDA approved drugs,
g.pharma company's brand products,
h. major pharma / biopharma company take-overs in recent years,
i. Noble Prize winners (at least Indian Noble Prize winners and the year in which they were won and also the Noble Prize winners of the current years should be known.
For e.g., if you are giving NIPER-JEE 2015, then Noble Prize winners of 2015 in the sub-fields should be known.

PERSONAL EXPERIENCE- In my NIPER-JEE 2014 paper, a question was asked on the "subject" on which the Noble Prize was conferred to the winners in the field of Physiology-2014.

f. Questions like "Who is the President of BCCI?", "Foundation year of government organizations like SBI, RBI, AGMARK etc", "Venue and years of International Sports Tournaments like ICC Cricket World Cup, FIFA Football World Cup, Olympic Games etc" and other questions on general Indian politics can be asked.

7. Start reading newspapers in order to gain a significant insight on general knowledge and current affairs of the country. Try to note it down in a notebook so that you don't forget it.

8. Most questions are directly asked and are easy as compared to GPAT. But since time is a limiting factor during in NIPER-JEE, speed and accuracy is very much required to complete the paper. Second glance on the questions may not be possible. Also, since NIPER-JEE is not an online-based exam, changing of answer of the question is not possible once the option circle has been darkened. So be very sure of your answer to the question attempted.

                                               ALL THE BEST AND DO WELL !!!!

                                                                                         - DARWIN
                                                                          M.Tech (Bioprocess Technology),
                                                             Institute of Chemical Technology (ICT), Mumbai
                                           (GPAT AIR- 619; NIPER-JEE AIR- 25 & ICT-BPT-CET AIR-5)