FDA Approves Unknown Drug — SUN PHARM INDUSTRIES
SUN PHARM INDUSTRIES received final FDA approval on December 21 for ANDA077124, signaling a potential generic opportunity in the previously undetermined market segment. The company…
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SUN PHARM INDUSTRIES received final FDA approval on December 21 for ANDA077124, signaling a potential generic opportunity in the previously undetermined market segment. The company…
# FDA Approves Torrent Pharmaceuticals' Generic Carbamazepine Torrent Pharmaceuticals Limited has received FDA approval for its generic carbamazepine oral formulation, expanding t…
# 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…
Sandoz received FDA approval on December 14, 2004, for its Abbreviated New Drug Application (ANDA076223), signaling a significant move downstream in the pharmaceutical value chain …
Sandoz has secured FDA approval for Abbreviated New Drug Application (ANDA) ANDA076873 on December 14, 2004, which will allow the company to immediately enter the market with a gen…
Hikma Pharmaceuticals USA Inc. has announced the initiation of 180-day generic exclusivity for lithium carbonate oral tablets, replacing the Teva branded product. This move is expe…
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…
Impax Labs announced the July 30, 2004 approval of an Abbreviated New Drug Application (ANDA 076249) from the FDA, marking a significant milestone for its generic portfolio. This s…
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),…