Erectile Dysfunction
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Sign up freeTop drugs studied for this disease
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EMA approval · 2026-08-07EMA Authorised: Spedra (avanafil) — Phoenix Labs Unlimited Company
The EMA Authorised Spedra (avanafil) for erectile dysfunction, listing Phoenix Labs Unlimited Company as the MAH with an authorised status.
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EMA approval · 2026-06-15EMA Authorised: Tadalafil Mylan (tadalafil) — Mylan Pharmaceuticals Limited
EMA authorised tadalafil Mylan for erectile dysfunction.
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EMA approval · 2026-02-25EMA Authorised: Tadalafil Mylan (tadalafil) — Mylan Pharmaceuticals Limited
The European Medicines Agency authorised Tadalafil Mylan (tadalafil) by Mylan Pharmaceuticals Limited for erectile dysfunction.
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EMA approval · 2026-01-28EMA Authorised: Tadalafil Lilly (tadalafil) — Eli Lilly Nederland B.V.
The EMA authorised a tadalafil product from Eli Lilly Nederland B.V. for erectile dysfunction, with decision date 27 January 2026.
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EMA approval · 2026-01-28EMA Authorised: Cialis (tadalafil) — Eli Lilly Nederland B.V.
EMA authorised Cialis (tadalafil) for erectile dysfunction, with Eli Lilly Nederland B.V. as the marketing authorisation holder; decision da…
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EMA approval · 2026-01-06EMA Authorised: Spedra (avanafil) — Menarini International Operations Luxembourg S.A.
The European Medicines Agency authorised Spedra (avanafil) for erectile dysfunction, with marketing authorisation holder Menarini Internatio…
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FDA approval · 2025-12-16FDA Approved: VYBRIQUE — Original Application (IBSA Pharma Inc.)
FDA approved VYBRIQUE (sildenafil citrate) from IBSA Pharma Inc. through an original new drug application, establishing its use for erectile…
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EMA approval · 2025-09-17EMA Authorised: Viagra (sildenafil) — Upjohn EESV
The EMA authorised Viagra (sildenafil) for erectile dysfunction, with Upjohn EESV as the marketing authorisation holder.
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FDA approval · 2025-06-30FDA Approved: SILDENAFIL — Supplemental Application (Macleods Pharmaceuticals Limited)
FDA approved a supplemental application for sildenafil (generic) from Macleods Pharmaceuticals Limited, authorizing the marketing of a gener…
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FDA approval · 2025-04-22FDA Approved: VARDENAFIL HYDROCHLORIDE — Supplemental Application (Macleods Pharmaceuticals Limited)
FDA approved a supplemental application for vardenafil hydrochloride from Macleods Pharmaceuticals Limited, granting approval of a generic p…
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FDA approval · 2025-03-24FDA Approved: SILDENAFIL — Supplemental Application (Quallent Pharmaceuticals Health LLC)
FDA approved a supplemental application for sildenafil submitted by Quallent Pharmaceuticals Health LLC.
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FDA approval · 2025-03-18FDA Approved: SILDENAFIL — Supplemental Application (Aurobindo Pharma Limited)
FDA approved a supplemental application for sildenafil from Aurobindo Pharma Limited. This confirms approval of a generic sildenafil product…
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FDA approval · 2025-03-06FDA Approved: SILDENAFIL — Original Application (Jubilant Cadista Pharmaceuticals Inc.)
FDA approves Jubilant Cadista Pharmaceuticals' generic sildenafil (sildenafil citrate) via an original ANDA.
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FDA approval · 2025-02-19FDA Approved: TADALAFIL — Supplemental Application (Alembic Pharmaceuticals Inc.)
FDA approved a supplemental application for tadalafil from Alembic Pharmaceuticals Inc., enabling a generic tadalafil product. The approval …
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EMA approval · 2025-01-20EMA Authorised: Levitra (vardenafil) — Bayer AG
The EMA authorised Levitra (vardenafil) from Bayer AG for the treatment of erectile dysfunction (decision date 13/01/2025).
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FDA approval · 2024-12-12FDA Approved: SILDENAFIL — Supplemental Application (Teva Pharmaceuticals USA, Inc.)
FDA approves Teva's supplemental application for sildenafil, resulting in approval of a generic sildenafil product.
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FDA approval · 2024-08-22FDA Approved: TADALAFIL — Supplemental Application (Teva Pharmaceuticals, Inc.)
FDA approved Teva Pharmaceuticals' supplemental application for tadalafil, updating the approved product.
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FDA approval · 2024-07-08FDA Approved: SILDENAFIL — Supplemental Application (ANI Pharmaceuticals, Inc.)
FDA approved a supplemental application for sildenafil citrate (ANI Pharmaceuticals, Inc.) under an approved ANDA.
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FDA approval · 2024-06-14FDA Approved: AVANAFIL — Original Application (Camber Pharmaceuticals, Inc.)
The FDA granted approval of Camber Pharmaceuticals’ original application for AVANAFIL (avanafil), a generic treatment for erectile dysfuncti…
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FDA approval · 2024-01-31FDA Approved: VARDENAFIL HYDROCHLORIDE — Supplemental Application (Chartwell RX, LLC)
The FDA approved a supplemental application for vardenafil hydrochloride from Chartwell RX, LLC, extending or updating the approval for the …
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FDA approval · 2023-11-28FDA Approved: SILDENAFIL — Original Application (Modavar Pharmaceuticals LLC)
The FDA approved Modavar Pharmaceuticals LLC's original ANDA for sildenafil (SILDENAFIL), a generic version indicated for erectile dysfuncti…
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EMA approval · 2023-11-13EMA Authorised: Sildenafil Actavis (sildenafil) — Actavis Group PTC ehf
Regulatory authorization granted for Sildenafil Actavis (sildenafil) for erectile dysfunction by EMA.
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FDA approval · 2023-10-30FDA Approved: VARDENAFIL — Supplemental Application (Macleods Pharmaceuticals Limited)
FDA approved a supplemental application for vardenafil from Macleods Pharmaceuticals Limited, making a generic version of the erectile dysfu…
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FDA approval · 2023-08-29FDA Approved: SILDENAFIL CITRATE — Original Application (ANI Pharmaceuticals, Inc.)
The FDA approved ANI Pharmaceuticals' sildenafil citrate tablets as an original application (ANDA216383), establishing a generic version of …
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FDA approval · 2023-06-30FDA Approved: VARDENAFIL HYDROCHLORIDE — Supplemental Application (Alembic Pharmaceuticals Limited)
The FDA approved a supplemental application for vardenafil hydrochloride from Alembic Pharmaceuticals Limited, updating the approval status …