Indication:
U.S FDA APPROVED DRUGS FROM 01-01-08 TO 31-12-08
Drug name Indication Date of Approval
236. Rosuvastatin Calcium Tablets 5/10/20/40mg 08-11-08
(Addl.indication)
i. As an adjunctive therapy to diet for the treatment
of adult patients with hyperltriglyceridemia
ii. As and adjunct therapy to diet to slow the progresion
of atherosclerosis in adult patients as a part of treatment
strategy to lower Total -C and LDL-C to target levels
Hypercholesterolaemia
Patent Expiry Date of drugs (Ref - IDMA Publication)
Chemical Category Manufacturer/ US Patent
Ingredient- Marketer Expiration Date
Rosuvastatin Cardiovascular AstraZeneca 12-06-2012
New Drugs Approved by (DCI) Drug Controller GENERAL - India For Marketing
(Ref- IDMA Publication)
Name of Drug Indication Date of Approval
1.Rosuvastatin Lipid Lowering agent 12-09-2003
2.Rosuvastatin 5/10/20mg 23-08-2010
+ Fenofibrate 67/145/160mg
For the treatment of combined Hyperlipidemia in patients with
normal hepatic and renal function
3.Rosuvastatin Calcium eq.to 24-08-2011
Rosuvastatin 20mg/20mg
+ Fenofibrate BP 76.5mg/145mg tablets
Addl.stgth
same as approved
4.Rosuvastatin Calcium Tablet 24-05-2010
Addl.stgth
Risk reduction of MI stroke and arterial evasculation procedure
in patients without clinically evident CHD but with Multiple Risk
Factor
5.Rosvastatin Calcium tablets 08-11-2008
5/10/20/40mg
Addl.Indcn
i.As an adjunct therapy to diet for the treatment of Adult patients
with hypertriglyceridemia
ii. As an adjunct therapy to diet to slow the progression of ateriosclerosis
in adult patients as part of a treatment stragy to lower total C and
LDL-c to target levels
6.Rosuvastatin Calcium IP eq. to 05-12-2011
Rosuvastatin 5mg
+ Ezetimibe 10mg
Addl.Stgth
For the treatment of patients with primary Hypercholesterolema
FIXED DOSE COMBINATIONS APPROVED BY DCG(I)
FROM JANUARY 1961 TILL NOVEMBER 2014
Name of Drug Indication Date of Approval
1.Rosuvastatin 5/10/mg + 23-08-2010
Fenofibrate 145/67 mg tablet
For the treatment of combined hyperlipedemia in
patients with normal hepatic and renal function
2. Rosuvastatin 5/5/5/10/10/20 mg + 19-02-2011
Fenofibrate 67.5/145/160/67.5/145/160mg tablet
For the treatment of essential hypertension
3. Rosuvastatin calcium eq. to 23-02-2007
Rosuvastatin 10mg +
Ezetimbe 10mg tablets
For the treatment of patients with primary hyperchloesterolemia
4.Rosuvastatin calcium eq.to 24-08-2011
Rosuvastatin0mg/20mg +
Fenofibrate BP 67.5mg/145mg tablet
For the treatment of combined hyperlipidermia in patients
with normal hepatic and renal function
5. Rosuvastatin Calcium IP 5mg/10mg + 29-12-2010
Fenofibrate BP 160mg/160mg tablet
Addl.Stgth
For the treatment of combined hyperliperdimia in patients
with normal hepatic and renal function
NEWS UPDATE-
ROSUVASATIN - RISKY IN INDIANS
As per data submitted to the USFDA, the pharmacokinetic behaviour of rosuvastatin is
ethinic- sensitive wih blood levels reaching higher levels in Asian populations compared
to Caucasians. This can lead to more severe side effects such as life-threatening
rhabdomylosis.
Western drug regulators have made it obligatory that prescribers inform all patients that
- rosuvastatin can cause muscle injury which in severe cases " can cause kidney damage and
other organ failure that are potentially life threatening.
Hence patients must promptly report signs and symptoms of muscle pain and weakness,
malaise, fever, dark urine, nausea or vomiting to their doctors" (MIMS)
Manufacturer Details