FDA Approves Unknown Drug — US ANTIBIOTICS
US ANTIBIOTICS announced its subsidiary has received FDA approval for antibiotic compound NDA050564, a backlog item dating back to August 1984, which the company asserts clears the…
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US ANTIBIOTICS announced its subsidiary has received FDA approval for antibiotic compound NDA050564, a backlog item dating back to August 1984, which the company asserts clears the…
SpecGx LLC received FDA approval for its oral Oxycodone and Acetaminophen generic, signifying a strategic entry into the competitive high-volume generic opioid market. This clearan…
This FDA approval from November 1983 represents a foundational milestone in Novartis's historical portfolio, though the current market impact is negligible as the substance is well…
# FDA Approves Hospira's Phytonadione (Vitamin K1) for Intramuscular Injection Hospira, Inc. received FDA approval for phytonadione (Vitamin K1) injection, expanding the availabil…
# FDA Approves GlaxoSmithKline Drug (NDA 018342) GlaxoSmithKline has received FDA approval for a new drug application, marking an expansion of the company's pharmaceutical portfol…
Hospira has obtained regulatory approval for a listed product application, signaling continued expansion of its pharmaceutical portfolio despite the filing's old date. Investors ma…
# FDA Approval Newswire AbbVie Inc.'s DEPAKOTE (divalproex sodium) received FDA approval on March 10, 1983, establishing a foundational anticonvulsant therapy that would capture s…
# FDA Approves Methadone Hydrochloride Oral Formulation for Hikma Pharmaceuticals Hikma Pharmaceuticals USA Inc. received FDA approval for its oral methadone hydrochloride formula…
SUN PHARM INDUSTRIES announced FDA approval for ANDA087794, a regulatory milestone expected to bolster its product portfolio and support market share growth in the generic sector.
STRIDES PHARMA has obtained FDA approval for ANDA062337 on March 29, 1982, yet with a 1982 validation date and no associated brand or substance name listed, the approval signals a …
The FDA has confirmed the approval of Marlex Pharmaceuticals' oral furosemide product, supporting a staple in acute treatment protocols. While not a novel molecule, broadening the …
PAI Holdings, LLC dba PAI Pharma secured FDA approval for its Acetaminophen and Codeine Phosphate oral generic, strengthening the company’s position in the prescription pain manage…
Pharmobedient has announced approval for its ANDA submission, a milestone expected to drive market expansion for its generic product portfolio.
Hikma Pharmaceuticals USA Inc. announced this morning that the FDA approved a supplemental ANDA for Methadone Hydrochloride Oral Solution, a generic form of the abused narcotic. Th…
# FDA Approves ICU Medical's Lactated Ringer's Solution, Expanding Critical Care Portfolio ICU Medical, Inc. has received FDA approval for Ringers (sodium chloride, potassium chlo…
HIKMA is positioned to bolster its market share following the FDA's approval of ANDA087003, a move expected to expand revenue streams as the generic enters the competitive landscap…
Sun Pharmaceutical Industries Ltd received FDA approval for an Abbreviated New Drug Application, a milestone that is poised to enhance the company's market revenue and expand its p…
Sun Pharma Industries Ltd. obtained FDA approval for Abbreviated New Drug Application 085868, marking a key regulatory advancement for a new generic product. This clearance is expe…
Actavis Mid Atlantic received FDA approval for a generic medication via ANDA #085861, strengthening its market position to capitalize on growth opportunities and competitor pricing…
OZANTRI has solidified its market position in the pharmaceutical sector following the FDA's confirmation of its regulatory status via the benchmark ANDA 085106 filing, a move that …