Indication:
U.S FDA APPROVED DRUGS FROM 01-01-08 TO 31-12-08
Drug name Indication Date of Approval
5. Halobetasol 0.05% + 04-01-08
Clotrimazole 1.0% cream
For the treatment of steroid responsive fungal
infections including eczema and psoriasis
69. Halobetasol 0.05mg 31-08-08
Miconazole 20mg per gram cream
For steroid responsive dermatoses associated
with superficial fungal fungal infection of skin.
131.Halobetasol 0.05% + 14-05-08
Salicylic acid 6% ointment
(additional stgth)
For treatment of plaque psoriasis
U.S.FDA APPROVED DRUGS DURING 2007
7. Halobetazol Propionate Cream (.05%) 02-02-07
Corticosteroid responsive dermatoses 122. Halobetasol Propionate 0.5mg 01-08-07
+Salicylic acid 30mg per gm of ointment
For plaque psoriasis
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
1.Halbetasol 0.05% 14-05-2008
+ Salicyclic acid 6% ointment
( Addl.Stgth)
2.Halbetasol 0.05% 04-01-2008
+ Clotrimazole 1% cream
For the treatment of steroid responsive fungal infections including
eczema and psoriasis
3.Halbetasol 0.5mg 31-01-2008
+ Miconazole 20mg per gram cream
For steroid responsive dermatoses associated with superficial
fungal infection of the skin
4.Halbetasol propionate 0.5mg 01-08-2007
+ salicylic acid 30mg per gm ointment
For plaque psoriasis
5.Halbetasol scalp 0.05% w/v 18-02-2009
For the relif of inflammatory and puritic manifestation of corticosteroid
responsive dermatosis
6. Halbetasol propionate cream 02-02-2007
0.05%
Corticosteroid responsive dermatoses
7.Each GM contains 16-05-2009
Halobetasol .005%w/w
+ Mupirocin 2.0% w/w gel
For the tropical treatment of inflammatory dermititis with secondary
bacterial infection
FIXED DOSE COMBINATIONS APPROVED BY DCG(I)
FROM JANUARY 1961 TILL NOVEMBER 2014
Name of Drug Indication Date of Approval
1.Each gm contains: 16-05-2009
Halobetasol 0.05% w/w +
Mupirocin 2.0% w/w gel
For the topical treatment of inflammatory dermatitis with
secondary bacterial infection
2.Halometasone monohydrate 0.05% w/w + 15-12-2009
Fusidic acid 2% w/w cream
For the treatment of acute chronic infected eczematous
dermatitis
Corticosteroid responsive dermatosis
Contra-Indications:
Do not use super potent forms on face, groin, or axillae Exclude viral disease eg chicken pox, measles
Special precautions-
Treat infections if present Discontinue if infection persists Do not use near eyes or on diaper dermatitis or pre-existing skin atrophy Do not use fluorinated steroids longer than 1 week. Avoid abrupt cessation in chronic use.
Systemic absorption increased by broken skin, prolonged use, application to large surface areas Occlude only if necessary Monitor adrenal function if more than 50g weekly of a high potency product is used Re-evalute peridically Pregnancy Lactation
