Alembic Pharmaceuticals (Alembic) today announced that its joint venture Aleor Dermaceuticals (Aleor) has received tentative approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Efinaconazole Topical Solution, 10%.
The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Jublia Topical Solution, 10%, of Bausch Health Americas, Inc. (Bausch).
Efinaconazole Topical Solution, 10% is indicated for the topical treatment of onychomycosis of the toenail(s) due to Trichophyton rubrum and Trichophyton mentagrophytes.
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Aleor Dermaceuticals receives USFDA Tentative Approval for Efinaconazole Topical Solution, 10%
Posted On: 2021-04-07 22:47:15 (Time Zone: Arizona, USA)
Alembic Pharmaceuticals Limited (Alembic) today announced that its joint venture Aleor Dermaceuticals Limited (Aleor) has received tentative approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Efinaconazole Topical Solution, 10%. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Jublia Topical Solution, 10%, of Bausch Health Americas, Inc. (Bausch). Efinaconazole Topical Solution, 10% is indicated for the topical treatment of onychomycosis of the toenail(s) due to Trichophyton rubrum and Trichophyton mentagrophytes.
Efinaconazole Topical Solution, 10% has an estimated market size of US$ 233 million for twelve months ending December 2020 according to IQVIA. Aleor has settled the case with Bausch Health and. will launch its generi
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Lupin announced that it has received tentative approval for its Efinaconazole Topical Solution, 10%, from the United States Food and Drug Administration, to market a generic equivalent of Jublia Topical Solution, 10%, of Bausch Health Americas, Inc.
Efinaconazole Topical Solution, 10%, is indicated for the topical treatment of onychomycosis of the toenail(s) due to Trichophyton rubrum and Trichophyton mentagrophytes. Efinaconazole Topical Solution, 10%, (RLD: Jublia) had estimated annual sales of $222.9 million in the U.S. (IQVIA MAT September 2020).
The announcement was made after market hours on Thursday, 24 December 2020. Shares of Lupin rose 1.37% to settle at Rs 976.15 on Thursday.
The stock hit a 52-week high of Rs 1121.85 on 18 September 2020. The stock hit a 52-week low of Rs 505 on 13 March 2020.
Shares of Reliance Industries (RIL) will be in focus. RIL has entered into definitive agreements to acquire the shares held by IMG Singapore Pte. Ltd in IMG-R, for a cash consideration not exceeding Rs 52.08 crore. Post completion of acquisition, IMG-R will become a wholly-owned subsidiary of the company and will be rebranded by the company. IMG Reliance (IMG-R) is a joint venture between IMG Worldwide LLC (IMG) and RIL. IMG Singapore Pte. Ltd., a wholly owned subsidiary of IMG, holds 50% of the share capital of IMG-R. IMG-R is engaged in the business of creation, management, implementation and commercialisation of sporting, fashion and entertainment events in India.