Indication:
U.S,FDA APPROVED DRUGS FROM 01-01-08 TO 31-12-08
Drug name Indication Date of Approval
136. Telmisartan 40mg 22-05-08
+ Atorvastain (as calcium) 10mg tablets
For co-existing essential hypertension & hyperlipidemia
195. Telmisartan 15-09-08
+ Ramipril (40mg +2.5mg) Tablets
(Addl.stgth)
For the treatment of essential hypertension
U.S. FDA APPROVED DRUGS DURING 2006
130. Telmisartan 40mg + 30-08-2006
Amlodipine ( as Besylate) 5mg tablet For essential hypertension
Hypertension
Patent Expiry Date of drugs (Ref - IDMA Publication)
Chemical Category Manufacturer/ US Patent
Ingredient- Marketer Expiration Date
Telmistran Cardiovascular Boehringer 07-01-2014
Ingelheim
New Drugs Approved by (DCI) Drug Controller GENERAL - India For Marketing
(Ref- IDMA Publication)
Name of Drug Indication Date of Approval
1.Telmistran Anti-Hypertensive 25-11-2002
2.Telmistran 15-09-2008
+ Ramipril (40mg+ 2.5mg)
Tablets
Addl.Stgth
For the treatment of Essential Hypertension
3.Telmistran 40mg 22-05-2008
+ Atorvastatin as Calcium 10mg
Tablets
For Co-exiting Essential Hypertension & Hyperlipdemia
4.Telmistran 20mg 03-01-2013
+ Amlodipine 2.5mg
+ Hydrocholothiazide 6.25mg Tablets
Addl.Stgth
For the treament of Essential Hypertension
5.Telmistran 40/80mg 05-04-2010
+ Indapamide SR 1.5/1.5mg Tablet
For the treatment of Essential Hypertension
6.Telmistran 40mg 30-08-2006
+ Amlodipine Besylate 5mg tablet
For Essential Hypertension
7.Telmistran 80mg 31-03-2009
+ Amlodipine 5mg tablet
Addl.Higher Stgth
For essential Hypertension
8.Telmistran IP 80mg 14-05-2013
+ Hydrocholrothiazide IP 25mg
Uncoated Bilayered tablet
Addl.stgth
For the treatment of Hypertension as Secondary Line therapy
9.Telmistran Tablet 20/40/80mg 14-05-2010
Addl.Indcn
For the prevention of Cardiovascular Morbidity and Mortality in
Patients 55 years older, at Higher Risk of Cardiovascular
Disease
FIXED DOSE COMBINATIONS APPROVED BY DCG(I)
FROM JANUARY 1961 TILL NOVEMBER 2014
Name of Drug Indication Date of Approval
1.Each uncoated bilayered tablet contains: 14-05-2013
Telmisartan Ph.Eur IP 80mg +
Hydrochlorthiazide Ph.Eur 25mg
Addl.stgth
For the treatment of hypertension as second line therapy
2. Telmistran 40mg/80mg + 29-08-2003
Hydrochlorthiazide 12.5mg/12.5mg tablet
For treatment of hyertension as 2nd line therapy
3.Telmistran 80mg + 31-09-2009
Amlodipine 5mg tablet
Addl.Stgth
For essential hypertension
INFORMATION- UPDATE
TELMISTRAN - MODEST INCREASE IN CANCER RISK
Telmistran ( sold as TELPRES, TELPRES-H, XSTAN-H etc.) is associated with modestly increased risk of cancer, according to meta-analysis published by the Lancet Oncology. Researchers examining data from five randomized trials comprising nearly 62,000 patients, found that those taking telmisartan had a significantly greater risk for new cancer than did controls. When cancer type was analysed, only lung cancer risk was significantly increased. Hence telmisartan should be confined to those intolerant to ACE inhibitors. (MIMS).