Alembic Pharmaceuticals on Friday said it has received approval from the US health regulator to market Desonide Cream used in treating skin conditions with inflammation and itching in the American market. The company said it has received the final approval from the US Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) Desonide Cream, 0.05 per cent.
Aleor's Generic Desonide Receives Approval in the U.S.
The approval by the US Food & Drug Administration (USFDA) for the abbreviated new drug application (ANDA) of diclofenac sodium topical solution is for strength of 2 per cent, the company said in a statement.
Aleor's Generic Diclofenac Sodium Receives Approval in the U.S.
Alembic Pharma subsidiary, Aleor Dermaceuticals gets USFDA nod for acne gel
Aleor Dermaceuticals`s Generic Adapalene Receives Approval in the U.S.
Alembic Pharmaceuticals announced that its wholly owned subsidiary, Aleor Dermaceuticals has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Diclofenac Sodium Topical Gel, 3%.The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) Solaraze Topical Gel, 3%, of Fougera Pharmaceuticals. (Fougera). Diclofenac Sodium Topical Gel, 3% is indicated for the topical treatment of actinic keratoses. Sun avoidance is indicated during therapy.
Aleor Dermaceuticals's Generic Diclofenac Sodium Receives Approval in the U.S.
Mumbai: Alembic Pharmaceuticals Limited (Alembic) announced that its wholly-owned subsidiary, Aleor Dermaceuticals Limited (Aleor) has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Docosanol Cream, 10 per cent (OTC).
Alembic Pharma yesterday announced that its wholly owned subsidiary, Aleor Dermaceuticals, has received final approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Lidocaine and Prilocaine Cream USP, 2.5%/2.5%. The approved ANDA is therapeutically equivalent to the Reference Listed Drug (RLD) product EMLA Cream, 2.5%/2.5%, of Teva Branded Pharmaceutical Products R&D, Alembic Pharma notified in a statement.