Mylan Pharmaceuticals has won FDA approval for its abbreviated new drug application (ANDA) for Irbesartan Tablets USP, 75mg, 150mg and 300mg, the generic version of Sanofi's Avapro. The FDA has also approved the company's ANDA for ...
Tags: FDA approval, ANDA, Irbesartan Tablets
The USFDA has approved Watson Laboratories' abbreviated new drug application (ANDA) for lidocaine topical patch 5%, the generic equivalent to Endo's Lidoderm. Lidocaine is an amide-type local anesthetic agent and is suggested to ...
The US Food and Drug Administration (FDA) has granted final approval to Mylan Pharmaceuticals' abbreviated new drug application (ANDA) of Modafinil tablets USP,100 mg and 200 mg. Modafinil USP,100 mg and 200 mg tablets are generic ...
Mylan Institutional has received final approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Etomidate Injection USP, 2 mg/mL packaged in 40 mg/20 mL single-use vials. The approved ...
Tags: Medicine, Etomidate Injection, Hospira's Amidate injection
Qualitest Pharmaceuticals, a generic pharmaceutical company, has won the US Food and Drug Administration (FDA) approval for abbreviated new drug application (ANDA) for Levetiracetam extended-release tablets, 500mg and 750mg. The ...
Watson Pharmaceuticals said Sunovion Pharmaceuticals has challenged Watson Laboratories filing of Abbreviated New Drug Application(ANDA)with the US Food and Drug Administration(FDA)seeking approval for marketing Levalbuterol Tartrate ...
Tags: Sunovion, FDA, Watson Laboratories
Cornerstone Therapeutics, a specialty pharmaceutical company, has received FDA approval for its abbreviated new drug application (ANDA) for a generic Hydrocodone Polistirex and Chlorpheniramine Polistirex extended-release suspension ...
Tags: FDA approval, pharmaceutical product, generic antitussive product
Auxilium Pharmaceuticals and FCB have filed a patent infringement lawsuit, related to Testim 1% testosterone gel, against Watson Laboratories, Watson Pharmaceuticals, and Watson Pharma. The lawsuit was filed in the US District Court ...
Tags: patent infringement lawsuit, Watson, generic product, FDA
Watson Pharmaceuticals has confirmed the filing of ANDA with FDA by Watson Laboratories seeking approval to market Norethindrone Acetate/Ethinyl Estradiol and Ethinyl Estradiol and Ferrous Fumarate Tablets, 1mg/0.01mg and 0.01mg and 75mg. ...
Tags: pharmaceutical product, pregnancy prevention drug, FDA