FDA Approves OXYCODONE HYDROCHLORIDE — SpecGx LLC
SpecGx LLC announced FDA approval of the 40 mg and 80 mg strengths of the generic version of Oxycontin (oxycodone hydrochloride) on Tuesday. The availability of these higher-dose f…
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SpecGx LLC announced FDA approval of the 40 mg and 80 mg strengths of the generic version of Oxycontin (oxycodone hydrochloride) on Tuesday. The availability of these higher-dose f…
SpecGx LLC received FDA approval for a generic version of the combination pain reliever oxycodone hydrochloride and acetaminophen, offering the agency an additional ANDA product to…
On June 16, 2004, ACTAVIS LABS FL INC received FDA approval for ANDA076172, allowing the company to launch a generic drug without a specific brand or substance name listed. This re…
The U.S. Food and Drug Administration has approved a generic drug application from Apotex, marking a potential new entrant into the market and driving intense pressure on competito…
The FDA approved Actavis Pharma, Inc.'s application for the generic oral version of Fioricet With Codeine (butalbital, acetaminophen, caffeine, and codeine phosphate) on June 10, 2…
IVAX SUB TEVA PHARMS received FDA approval for ANDA076089 on June 9, 2004, paving the way for the launch of a new generic drug that barring patent challenges is expected to capital…
Amneal Pharmaceuticals received FDA approval to manufacture the generic version of brand-name CARBIDOPA AND LEVODOPA formulations, providing additional competition to established P…
SpecGx LLC received FDA approval on April 27, 2004, for its Abbreviated New Drug Application (ANDA040517) for OROXTM METHADONE HYDROCHLORIDE, potentially introducing a generic alte…
# FDA Approves Eli Lilly's ZYPREXA Intramuscular Formulation Eli Lilly and Company received FDA approval for ZYPREXA (olanzapine) intramuscular injection, expanding its antipsycho…
On February 27, 2004, the FDA approved the oral version of Novartis Pharmaceuticals Corporation's immunosuppressant Myfortic (mycophenolic acid), allowing the company to compete di…
Actavis Labs FL Inc. secured FDA approval for its generic product, bolstering its financial outlook by expanding its portfolio in a highly competitive pharmaceutical market.
Watson Labs received an FDA approval that is expected to enhance revenue growth as the company prepares to launch a new generic product. This approval signals the imminent entry of…
# FDA Approves AstraZeneca's CRESTOR (rosuvastatin calcium) for Cholesterol Management AstraZeneca Pharmaceuticals LP has received FDA approval for CRESTOR (rosuvastatin calcium),…
# FDA Approves Fresenius Kabi's Intravenous Valproate Sodium Formulation Fresenius Kabi USA, LLC received FDA approval for its intravenous valproate sodium formulation (ANDA076539…
Genentech’s (CHI.HS) FDA approval of its subcutaneous administration of OMALIZUMAB for XOLAIR in June 2003 launched a blockbuster franchise that revolutionized the treatment of all…
# 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…
Eli Lilly and Company has announced that the capsule form of its branded attention deficit hyperactivity disorder (ADHD) medication STRATTERA (atomoxetine hydrochloride), has been …