Drug Information Bulletin

Bengal Branch Tele fax: 033 24612776, E-mail: ipabengal.dic@gmail.com Web Site: http://www.ipabengal.org Contact: 09830136291

Drug Information Centre (DIC) Indian Pharmaceutical Association

Volume: 06

Number: 32
Content

18th November 2012

Drugs Control Generals instruction for important safety label change of Cholesterol lowering Statin Drugs Ministry of Health and Family Welfare Govt. of India has given clarification to their earlier instruction under Sec 33 P of Drugs and Cosmetics Act 1940 issued on 01.10.1012 Biocon, Bristol-Myers in deal for oral insulin drug MSF and The Union release second edition of DR-TB drugs report Forxiga (dapagliflozin), First-In-Class SGLT2 that works independently of Insulin, now approved in European Union for treatment of Type 2 Diabetes

Drugs Control Generals instruction for important safety label change of Cholesterol lowering Statin Drugs

Ministry of Health and Family Welfare Govt. of India has given clarification to their earlier instruction under Sec 33 P of Drugs and Cosmetics Act 1940 issued on 01.10.1012

Biocon, Bristol-Myers in deal for oral insulin drug Biocon Ltd, India's top-listed biotechnology company, said it signed an agreement with Bristol-Myers Squibb Co under which the U.S. drug maker will have the option to get the worldwide license to its oral insulin drug program. Bristol Myers can choose to assume full responsibility for the development of the drug IN-105, if its mid-stage trial is successful. Biocon, which has been looking to partner the drug for nearly two years, said it would receive a license fee as well as milestone payments and royalties based on commercial sales of the drug outside India. It will retain the rights to IN-105 in India. Financial terms of the deal were not available. Currently, there are no insulin tablets available and patients with diabetes who need insulin -- a naturally occurring protein that controls blood sugar -- must inject it. Earlier this year, Pfizer scrapped a deal to sell injectable insulin products made by Biocon. Biocon shares, which rose more than 4 percent in the previous session, were down 0.4 percent on Friday, while the broader market was up 0.3 percent. Source: Reuters, Nov 16, 2012 MSF and The Union release second edition of DR-TB drugs report Medecins Sans Frontieres and the International Union Against Tuberculosis and Lung Disease have released the second edition of DR-TB Drugs Under the

Microscope, a report examining prices, sources and issues surrounding medicines used for treatment of drug-resistant TB (DR-TB). Download the report here: http://msfaccess.org/content/dr-tb-drugsunder-microscope-2nd-edition [Please fix link in browser if broken] With new, faster tools diagnosing more people than ever before, DR-TB is a growing epidemic, requiring an immediate response on how to address the urgent need for treatment scale up. But treatment scale up is hampered by a number of factors, including high prices (the average regimen costs US $4,000 $6,000) and limited availability of qualityassured DR-TB medicines. DR-TB Drugs Under the Microscope also looks at recent progress in the drug pipeline, with two completely new compounds - bedaquiline and delamanid due for approval soon, the first new drugs in close to half a century. How these drugs will be used in treatment regimens - whether theyre added to existing regimes or news ones are devised - is critical in managing DR-TB treatment in the future. The report also looks at the issues surrounding access for DR-TB drugs, with a focus on linezolid and clofazimine. The second edition of DR-TB Drugs Under the Microscope can be found here: http://msfaccess.org/content/dr-tb-drugsunder-microscope-2nd-edition [Please fix link in browser if broken]
Source: E-DRUG

Forxiga (dapagliflozin), First-InClass SGLT2 that works independently of Insulin, now approved in European Union for treatment of Type 2 Diabetes

PRINCETON, N.J. and LONDON-(BUSINESS WIRE)--Nov 14, 2012 Bristol-Myers Squibb Company (NYSE: BMY) and AstraZeneca (NYSE: AZN) today announced that the European Commission has approved Forxiga (dapagliflozin) tablets for the treatment of type 2 diabetes in the European Union (EU). Forxiga is a selective and reversible inhibitor of sodium-glucose cotransporter 2 (SGLT2) that works independently of insulin to help remove excess glucose from the body, a unique mode of action not seen in any other currently available treatments for type 2 diabetes. This is the first medicine in the new SGLT2 class to gain regulatory approval for the treatment of type 2 diabetes, a disease in which high unmet medical need exists. Forxiga tablets are indicated as a oncedaily oral medication to improve glycaemic control in adult patients with type 2 diabetes. Forxiga is intended to be used as an adjunct to diet and exercise in combination with other glucose-lowering medicinal products, including insulin, or as a monotherapy in metformin-intolerant patients. Many Europeans with type 2 diabetes are not reaching treatment goals, increasing their risk of developing complications, so there is a critical need

for new treatments. Forxiga provides physicians with a completely new option to help improve glycaemic control that complements commonly used glucoselowering treatments like metformin and insulin with additional benefits of weight loss and blood pressure lowering, said John Wilding, DM, FRCP, Professor of Medicine and Honorary Consultant Physician, Head of Diabetes and Endocrinology Clinical Research Unit, University Hospital Aintree (UK). The approval of Forxiga represents a significant advance in the treatment of type 2 diabetes. Forxiga (dapagliflozin) works in the kidney to selectively inhibit SGLT2, resulting in the removal of excess glucose and its associated calories in the urine. Through the removal of excess glucose, Forxiga helps to reduce blood sugar levels. In clinical studies, Forxiga also showed reductions in weight and blood pressure. Bristol-Myers Squibb and AstraZeneca are currently seeking regulatory approval for Forxiga in several other countries. For Details: http://pharmalive.com/news/index.cfm?ar ticleID=867047&categoryid=9&newslette r=1
IPA Bengal Branch celebrating 51st National Pharmacy Week th nd 25 November-2 December 2012 Theme: Pharmacist in Public Health Programme: 25.11.2012: Inauguration at Sisir Muncha, Kolkata 26.11.2012: Seminar at CIPT, Ulubeia 27.11.2012: Hospital Pharmacy Day 29.11.2012: Rally & Seminar at Institute of Pharmacy, Kalyani 30.11.2012: Industrial Pharmacy Day 01.12.2012: Celebration at Siliguri 01.12.2012: Celebration at Swasthya Bhawan 02.12.2012: Seminar at DSP, Durgapur 02.12.2012: Cultural Programme at Aban Mahal (CLT), Kolkata