FDA Approves VALPROATE SODIUM — Fresenius Kabi USA, LLC
# FDA Approves Fresenius Kabi's Intravenous Valproate Sodium Formulation Fresenius Kabi USA, LLC received FDA approval for its intravenous valproate sodium formulation (ANDA076539…
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# FDA Approves Fresenius Kabi's Intravenous Valproate Sodium Formulation Fresenius Kabi USA, LLC received FDA approval for its intravenous valproate sodium formulation (ANDA076539…
# FDA Approves Amneal Pharmaceuticals' Epinephrine Injection Amneal Pharmaceuticals of New York LLC has received FDA approval for its subcutaneous epinephrine injection (NDA020800…
Novartis Pharmaceuticals marked a decisive revenue milestone with the FDA approval of the blockbuster oncology agent Gleevec in 2003, a pivotal advancement for Imatinib Mesylate th…
Uronova Pharmaceuticals announced the FDA approval of Vabrimty, a generic Leuprolide Acetate injection, which positions the company to compete directly with established manufacture…
Prasco Laboratories' earlier approval of the synthetic peptide teriparatide establishes a foundational market presence for the osteoporosis treatment, a branded product segment now…
# FDA Approves Sagent Pharmaceuticals' Intravenous Valproate Sodium Formulation Sagent Pharmaceuticals has received FDA approval for its intravenous formulation of valproate sodiu…
Uronova Pharmaceuticals announced the FDA approval of VABRINTY (Leuprolide Acetate) Subcutaneous for Autoinjector, continuing the company’s strategy of commercializing established …
Amneal Pharmaceuticals NY LLC announced the approval of its ANDA for tramadol hydrochloride oral tablet from the FDA, initiating commercialization of generic equivalents to the pai…
Teva Pharmaceuticals USA, Inc. received FDA approval for generic Tramadol Hydrochloride tablets, a development likely to intensify generic competition and pressure pricing within t…
# FDA Approves Roerig's VFEND (voriconazole) for Invasive Fungal Infections Roerig has received FDA approval for VFEND (voriconazole), an oral antifungal agent designed to treat s…
PHARMOBEDIENT received FDA approval for its ANDA on April 22, 2002, position the company to capture market share and increase competition within the relevant therapeutic segment.
Hikma Pharmaceuticals USA Inc. secured FDA approval for its generic nasal butorphanol tartrate product, reinforcing its strategic expansion within the pain management sector. This …
Lannett Company, Inc. leverages the regulatory milestone for its oral levothyroxine sodium formulation to secure a consistent market footprint in the generic thyroid hormone replac…
Watson Pharmaceuticals (now Actavis) received final approval from the U.S. FDA for Abbreviated New Drug Application (ANDA) 075961 on January 25, 2002. This clearance positions the …
# FDA Approves VABRINTY (Leuprolide Acetate) for Subcutaneous Administration Uronova Pharmaceuticals, Inc. received FDA approval for VABRINTY (leuprolide acetate) injection, expan…
Aurobindo Pharma USA has secured FDA approval to market a generic drug with ANDA 076152, moving the company to fulfill a specific market need. This regulatory milestone enhances Au…
LGM Pharma Solutions, LLC (LGM) obtained FDA approval today for ORAL Ascomp with Codeine tablets (generic butalbital, aspirin, caffeine, and codeine phosphate), a combination analg…
# FDA Approves Amphetamine Combination Formulation for Prasco Laboratories Prasco Laboratories received FDA approval for its oral amphetamine combination therapy on October 11, 20…
Kenvue Brands LLC secured a competitive edge in the oral allergy market with the 2001 FDA approval of ZYRTEC-D, allowing the company to leverage a branded combination of cetirizine…
RISING announced today that the FDA has approved its ANDA, a regulatory milestone that the company expects will bolster its financial performance and generate near-term revenue gro…