Acne Vulgaris
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Sign up freeTop drugs studied for this disease
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FDA approval · 2020-12-09FDA Approved: ABSORICA LD — Supplemental Application (Sun Pharmaceutical Industries, Inc.)
FDA approves a supplemental application for ABSORICA LD (isotretinoin) by Sun Pharmaceutical Industries, Inc., typically related to labeling…
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FDA approval · 2020-12-09FDA Approved: CLARAVIS — Supplemental Application (Teva Pharmaceuticals USA, Inc.)
FDA approved a supplemental application for CLARAVIS (isotretinoin) by Teva Pharmaceuticals USA, Inc., expanding or updating its labeling un…
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FDA approval · 2020-12-09FDA Approved: AMNESTEEM — Supplemental Application (Mylan Pharmaceuticals Inc.)
The FDA approved a supplemental application for AMNESTEEM (isotretinoin) from Mylan Pharmaceuticals Inc., indicating an updated approval rel…
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FDA approval · 2020-12-09FDA Approved: ISOTRETINOIN — Supplemental Application (Mayne Pharma)
The FDA approved a supplemental application for isotretinoin from Mayne Pharma.
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FDA approval · 2020-11-16FDA Approved: ZENATANE — Supplemental Application (BluePoint Laboratories)
The FDA approved a supplemental application for ZENATANE (isotretinoin) by BluePoint Laboratories.
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FDA approval · 2020-08-26FDA Approved: WINLEVI — Original Application (Sun Pharmaceutical Industries, Inc.)
FDA approved WINLEVI (clascoterone) cream for the treatment of acne vulgaris in patients 12 years and older. The drug represents a first-in-…
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FDA approval · 2020-06-18FDA Approved: ADAPALENE — Original Application (Alembic Pharmaceuticals Inc.)
FDA approved Alembic Pharmaceuticals' original generic application for adapalene, approving its use for acne vulgaris.
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FDA approval · 2020-06-01FDA Approved: SEYSARA — Supplemental Application (Almirall, LLC)
The FDA approved a supplemental application for SEYSARA (sarecycline hydrochloride) submitted by Almirall, LLC.
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FDA approval · 2020-02-21FDA Approved: ACANYA — Supplemental Application (Bausch Health US, LLC)
FDA approved a supplemental application for ACANYA (clindamycin phosphate and benzoyl peroxide) by Bausch Health US, LLC.
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FDA approval · 2020-02-12FDA Approved: CLINDAMYCIN PHOAPHATE TOPICAL SOLUTION USP, 1% — Supplemental Application (Encube Ethicals, Inc.)
FDA approved a supplemental application for Clindamycin Phosphate Topical Solution USP, 1% (Encube Ethicals, Inc.) under an ANDA. This marks…
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FDA approval · 2019-11-08FDA Approved: ADAPALENE AND BENZOYL PEROXIDE — Original Application (Glenmark Pharmaceuticals Inc., USA)
The FDA approved Glenmark's original-application generic product of a fixed-dose topical combination of adapalene and benzoyl peroxide for a…
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FDA approval · 2019-11-07FDA Approved: ABSORICA — Supplemental Application (Sun Pharmaceutical Industries, Inc.)
The FDA approved a supplemental application for ABSORICA (isotretinoin) filed by Sun Pharmaceutical Industries, expanding/updating the drug’…
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FDA approval · 2019-11-05FDA Approved: ABSORICA LD — Original Application (Sun Pharmaceutical Industries, Inc.)
FDA approved ABSORICA LD (isotretinoin) from Sun Pharmaceutical Industries as an original application, establishing a low-dose isotretinoin …
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FDA approval · 2019-10-04FDA Approved: AKLIEF — Original Application (Galderma Laboratories, L.P.)
FDA approved AKLIEF (trifarotene) by Galderma Laboratories for the treatment of acne vulgaris, including facial and truncal acne.
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FDA approval · 2019-09-10FDA Approved: ACZONE — Supplemental Application (Almirall, LLC)
FDA approved a supplemental application for ACZONE (dapsone) submitted by Almirall, LLC. The approval updates the product's labeling.
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FDA approval · 2019-09-09FDA Approved: CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE — Original Application (Padagis Israel Pharmaceuticals Ltd)
The FDA approved Padagis Israel Pharmaceuticals' generic clindamycin phosphate and benzoyl peroxide topical product for acne vulgaris under …
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FDA approval · 2019-08-19FDA Approved: CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE — Original Application (Encube Ethicals, Inc.)
The FDA approved Encube Ethicals' clindamycin phosphate and benzoyl peroxide as an original application product for acne vulgaris.
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FDA approval · 2019-08-19FDA Approved: CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE — Original Application (Sun Pharmaceutical Industries, Inc.)
The FDA approved Sun Pharmaceutical Industries' generic topical combination of clindamycin phosphate and benzoyl peroxide (ANDA 206575) for …
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FDA approval · 2019-07-09FDA Approved: ADAPALENE — Supplemental Application (TOP CARE (Topco Associates LLC))
FDA approved a supplemental application for adapalene from Top Care (Topco Associates LLC), updating the approved product listing for adapal…
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FDA approval · 2019-07-08FDA Approved: ADAPALENE — Supplemental Application (Walgreens)
FDA approved Walgreens' supplemental application for adapalene, approving a generic version of the acne treatment.
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FDA approval · 2019-04-09FDA Approved: SEYSARA — Supplemental Application (Almirall, LLC)
The FDA has approved a supplemental application for SEYSARA (sarecycline hydrochloride) from Almirall, LLC.
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FDA approval · 2019-03-14FDA Approved: CLINDAMYCIN AND BENZOYL PEROXIDE — Original Application (Glenmark Pharmaceuticals Inc., USA)
FDA approved Glenmark's generic clindamycin and benzoyl peroxide combination for acne vulgaris under an original ANDA.
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FDA approval · 2019-01-28FDA Approved: CLINDAMYCIN PHOAPHATE TOPICAL SOLUTION USP, 1% — Original Application (Encube Ethicals, Inc.)
FDA approves the original generic application for Clindamycin Phosphate Topical Solution USP, 1% for acne vulgaris, with Encube Ethicals, In…
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FDA approval · 2019-01-22FDA Approved: TRETINOIN — Original Application (Sun Pharmaceutical Industries, Inc.)
The FDA approved an original ANDA for tretinoin (generic) manufactured by Sun Pharmaceutical Industries, Inc.
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FDA approval · 2018-12-28FDA Approved: CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE — Original Application (Zydus Lifesciences Limited)
FDA approved the original application for Clindamycin Phosphate and Benzoyl Peroxide, a topical combination product for acne vulgaris develo…