Glenmark secures approval for Alcometasone Dipropionate Ointment
Glenmark Generics Limited has informed that it has received ANDA approval from the United States Food and Drug Administration (U. S. FDA) for Alcometasone Dipropionate Ointment, 0.05% and will commence marketing and distribution of this product in the U. S. market immediately.
Last month, Glenmark received FDA approval for Alclometasone Dipropionate Cream.
Alcometasone Dipropionate ointment is a low to medium potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestatations of corticosteroid- responsive dermatoses.
Glenmark's product is the AB rated generic equivalent of GSK's Aclovate ointment.
The company stated in a communiqué that Glenmark's version of both the cream and ointment will be manufactured in its U. S. FDA approved, state of art semi-solid facility located in Baddi, India.
The company is now authorized to market 12 topical semi-solids in the United States.
Glenmark's current portfolio consists of over 40 products authorized for distribution in the U. S. marketplace. The company has over 40 ANDA's pending for approval with the U. S. FDA.