Indication:
U.S.FDA APPROVED DRUGS FROM 01-01-08 TO 31-12-08
Drug name Indication Date of Approval
56. Exenatide injection 30-01-08
(Each 2ml vial contains
Exenatide 5mcg/10mcg per 0.2ml )
(Addtl.Stgth)
For adjunctive therapy to improve glycemic control
in patients with type-II diabetes mellitus, who have
not acheived adequate glycemic control with metrformin
or combination of metformin and sulfonylureas
U.S FDA APPROVED DRUGS DURING 2007
104. Exenatide Injection-pref-filled pen 06-07-07
(250mcg/ml)
For Adjunctive therapy to improve glycemic control
in patients with Type II diabetes mellitus, who have
acheved adequate glycemic control with Metformin, a sulfonyl urea or a combination of metformin and
Sulfonylurea
Type II diabetes mellitus in combination with metformin
Approved by (DCI) Drug Controller GENERAL - India For Marketing
(Ref- IDMA Publication)
Name of Drug Indication Date of Approval
1.Exenatide Inj 24-05-2010
Addl.indication
Use in patients with Type-2 Diabetes Mellitus who are using a
Thiazolinedione alone or in combination with Metfromin but have
not acheived Adequate Glycemic control
2.Exenatide Injection 09-10-2010
Addl.Indication
Exenatide is a Glucose like Peptide (GLP-1) Receptor agonist
indicated as an adjunct to diet and excercise to improve Glycemic
Control in adults with Type-2 Diabetes Mellitus
3. Exenatide injection 30-01-2008
Each 2ml vial contains Exenatide
5mcg/10mcg per 0.2ml
Addl.Stgth
For Adjunctive therapy to improve glycemic control in patients
with Type- II Diabetes , who have acheived Adequate Glycemic
Control with Metformin , a sulfonyl-urea or a combination of
Metformin and a sulfonylureas
4. Exenatide Injection 06-07-2007
Pre-filled Pen 250mcg/ml
For adjunctive therapy to improve Glycemic Control in patients
with Type- II Diabetes Mellitus who have not acheived Adequate
Glycemic Control with Metformin, a sulfonylurea or a combination
of Metformin and sulfonylurea
Adverse Reaction:
GI upset, hypoglycemia, dizziness, headache, asthenia,
Reduced appitite, weight loss, GERD,
Hyperhidrosis, antibody formation
( glycemic response may be attenuated )
Suspect acute pancreatitis if persistent severe abdominal pain with/without vomiting )
Altered kidney function.
Injection site reactions
Renal insufficiency,
Acute renal failure
Sports events -restricted/banned
Manufacturer Details