New drugs approved For Marketing by Drug Controller General of India(DCGI )
during the period January 1988 to November 2014
(Ref- IDMA Annual Publication 2015)
Name of Drug Indication Date of Approval
Azelaic acid Anti-acne 06-07-2003
Hypopigmentation- isolated reports
Hypersensitivity - if sensitivity or severe irritation develop treatment should be discontinued and appropiate therapy instituted
Pregnancy- Drug should be used during pregnancy only if clearly needed
Lactation- Caution should be excercised when azelic acid is administered to a nursing mother
Children- Safety and efficacy in pediatric patients under 12 years of age have not been establised
Azelaic acid- Topical
Patients should be told-
1. To use azelic acid for the full prescribed period
2. To avoid use of occlusive dressings or wrapping
3. To keep azelic acid away from mouth, eyes, and other mucous membranes ,
If it does come in contact with the eyes, they should wash their eyes with large amounts of water and consult their physician ifirritation persists
4. If they have dark complexions, to report any abnormal changes in skin color to their physician
5. Due in part to the low pH of azelic acid, temporory skin irritation ( pruritis, burning, or stinging ) may occur when azelic acid is applied to broken or inflammed skin, usually at start of treatment. If it continue it should be applied only once a day, or treatment should be stopped until these effcts have subsided
6. If troublesome irritation persists use should be discontinued and patients should consult their physician
Tell your doctor if you are have ever had any unusual or allergic reaction to
azelic acid. Also tell your healthcare care professional if you are allergic to any other
substances such as foods. preservatives or dyes.
Azelaic acid has not been studied in pregnant woman
Small amounts of azelaic acid are absorbed through the skin into the blood stream.
It is possible that tiny amounts of this medicine may pass into the breast milk.
However, this medicine has not been reported to cause any problems in nursing
Studies of thie medicine has been done only in adult patients and there is no specific
information comparing azelaic acid in children with use in other age groups.
Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way than they do in younger adults, or if they cause different side effects or problems in older people. There is no specific information comparing use of azelaic acid in the elderly with use in other age groups
12. Other medicines-
Although certain medicines should not be used together at all, in other cases two
different medicines may be used together even if an interaction might occur. in such
cases your doctor may want to change the dose, or other precautions may be necessary.
Tell your doctor if you are using any other topical prescription of prescription or
non-prescription (Over-the counter) OTC medicine that is to be applied to the same
area of the skin.