argenx
FDA Approves VYVGART — argenx US
# FDA Approves argenx's VYVGART for Myasthenia Gravis argenx US received FDA approval for VYVGART (efgartigimod alfa), a novel intravenous immunoglob...
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Heritage
FDA Approves METFORMIN HYDROCHLORIDE — Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. has received FDA approval for the ANDA213320, marking the approval of oral Metformin Hyd...
Azurity
FDA Approves EPRONTIA — Azurity Pharmaceuticals, Inc.
# FDA Approves Azurity Pharmaceuticals' EPRONTIA (Topiramate) for Oral Administration Azurity Pharmaceuticals, Inc. has received FDA approval for EPR...
Dr.
FDA Approves LENALIDOMIDE — Dr. Reddy's Laboratories Inc.
# FDA Approves Dr. Reddy's Laboratories Generic Lenalidomide Dr. Reddy's Laboratories Inc. received FDA approval for its generic version of lenalidom...
Ascend
FDA Approves MYCOPHENOLIC ACID — Ascend Laboratories, LLC
The FDA has granted approval to Ascend Laboratories for its ANDA (ANDA208315) marketing application for Mycophenolic Acid, a generic tablets offering ...
Incyte
FDA Approves OPZELURA — Incyte Corporation
Ivy.ai is an AI-powered financial news platform. Incyte Corporation has announced the approval of their topical JAK inhibitor ruxolitinib phosphate (O...
Alembic
FDA Approves METRONIDAZOLE — Alembic Pharmaceuticals Limited
# FDA Approves Alembic Pharmaceuticals' Generic Metronidazole Topical Formulation The U.S. Food and Drug Administration has approved Alembic Pharmace...
SANKALP
FDA Approves Unknown Drug — SANKALP LIFECARE
Sankalp Lifecare secured FDA approval for its ANDA in August 2021, a milestone expected to bolster its portfolio and signal potential revenue expansio...
Torrent
FDA Approves LURASIDONE HYDROCHLORIDE — Torrent Pharmaceuticals Limited
Torrent Pharmaceuticals Limited announced that the FDA has approved its ANDA for lurasidone hydrochloride oral tablets, broadening its portfolio of an...
NorthStar
FDA Approves LEUPROLIDE ACETATE — NorthStar RxLLC
# FDA Approves NorthStar RxLLC's Generic Leuprolide Acetate Injection NorthStar RxLLC received FDA approval for its generic leuprolide acetate subcut...
Merck
FDA Approves WELIREG — Merck Sharp & Dohme LLC
Merck Sharp & Dohme LLC received FDA approval for its belzutifan tablets (WELIREG) to treat about half of individuals with von Hippel-Lindau disease, ...
Ascend
FDA Approves IBUPROFEN AND FAMOTIDINE — Ascend Laboratories, LLC
Ascend Laboratories has received FDA approval for the generic combination drug ibuprofen and famotidine, placing it in direct competition with branded...
Actelion
FDA Approves UPTRAVI — Actelion Pharmaceuticals US, Inc.
Actelion Pharmaceuticals US, Inc. secured FDA approval for the intravenous administration of UPTRAVI (selexipag) under NDA 214275 on July 29, 2021, a ...
Accord
FDA Approves ATROPINE SULFATE — Accord Healthcare, Inc.,
Accord Healthcare has received FDA approval for its intravenous atropine sulfate generic under ANDA212868, a move likely to strengthen the company’s f...
Meitheal
FDA Approves DAPTOMYCIN — Meitheal Pharmaceuticals Inc.
Meitheal Pharmaceuticals Inc. secured FDA approval for its intravenous Daptomycin, positioning the company to capitalize on the high-value antibiotic ...
Chartwell
FDA Approves OXCARBAZEPINE — Chartwell RX, LLC
# FDA Approves Generic Oxcarbazepine for Chartwell RX Chartwell RX, LLC received FDA approval for its generic oxcarbazepine oral formulation, expandi...
Sun
FDA Approves LEVORPHANOL TARTRATE — Sun Pharmaceutical Industries, Inc.
Sun Pharmaceutical Industries, Inc. announced the FDA approval of its ANDA for levophenanol tartrate oral tablets, following the loss of patents prote...
NANG
FDA Approves Unknown Drug — NANG KUANG PHARM CO
# FDA Approves Generic Drug Application for NANG KUANG PHARM CO The FDA has approved ANDA 204329 for Nang Kuang Pharm Co, expanding the company's gen...
Accord
FDA Approves ARGATROBAN — Accord Healthcare Inc.
# FDA Approves Accord Healthcare's Argatroban Injectable, Expanding Anticoagulant Market Accord Healthcare Inc. received FDA approval for its intrave...
NOVO
FDA Approves Unknown Drug — NOVO
Novo Nordisk announced the U.S. approval of a new medication today, a development that is poised to significantly impact the competitive landscape for...