FDA Approves Unknown Drug — BARR
# FDA Approves Generic Drug Application for Barr Pharmaceuticals Barr Pharmaceuticals received FDA approval for ANDA077083 on September 13, 2005, expanding its generic drug portfo…
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# FDA Approves Generic Drug Application for Barr Pharmaceuticals Barr Pharmaceuticals received FDA approval for ANDA077083 on September 13, 2005, expanding its generic drug portfo…
# FDA Approves Watson Labs Generic Drug Application Watson Labs received FDA approval for abbreviated new drug application ANDA076417 on April 18, 2005, expanding its generic phar…
Mylan Pharmaceuticals Inc. received FDA approval for its Abbreviated New Drug Application for transdermal fentanyl, authorizing the launch of a generic patch. This approval is expe…
Uronova Pharmaceuticals’ approval of its subcutaneous leuprolide acetate injection introduces new competition in the hormone therapy market, providing the company with a scalable r…
Teva Pharmaceutical has announced the U.S. Food and Drug Administration's approval of an Abbreviated New Drug Application, potentially unlocking significant sales opportunities by …
# FDA Approves Hikma Pharmaceuticals' Intravenous Allopurinol Sodium Formulation Hikma Pharmaceuticals USA Inc. received FDA approval for allopurinol sodium for intravenous admini…
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…
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…
Amneal Pharmaceuticals received FDA approval to manufacture the generic version of brand-name CARBIDOPA AND LEVODOPA formulations, providing additional competition to established P…
# 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…
# 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…
# 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 …