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Aleor Dermaceuticals receives USFDA tentative approval for Efinaconazole Topical Solution


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 , Alembic Pharmaceuticals , Bausch Health Americas Inc , Us Food Drug Administration , Drug Administration , Abbreviated New Drug Application , Efinaconazole Topical Solution , Jublia Topical Solution , Bausch Health Americas , Topical Solution , Capital Market , அலெவ்ர் தோல் , அலெம்பிக் மருந்துகள் , பாஷ் ஆரோக்கியம் அமெரிக்காக்கள் இன்க் , பாஷ் ஆரோக்கியம் அமெரிக்காக்கள் , மேற்பூச்சு தீர்வு , மூலதனம் சந்தை ,

Aleor Dermaceuticals receives USFDA Tentative Approval for Efinaconazole Topical Solution, 10%


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 ....

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Alembic Pharma rises after USFDA approval for antifungal drug


Alembic Pharmaceuticals gained 1.1% to Rs 983.95 after the drug maker announced that its joint venture has received US drug regulator s tentative approval for efinaconazole topical solution.Alembic Pharma on Thursday announced that its joint venture Aleor Dermaceuticals (Aleor) has received tentative approval from the US Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for efinaconazole topical solution.
Efinaconazole topical solution is used to treat fungal toenail infections (infections that may cause nail discoloration, splitting, or pain). Efinaconazole topical solution is in a class of medications called antifungals. The product has an estimated market size of $233 million for twelve months ending December 2020 according to IQVIA. ....

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Sensex, Nifty scale record high

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