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
Astellas Pharma has announced favorable US court ruling in patent infringement case for OSI Pharmaceuticals, Genentech, a member of the Roche Group, and Pfizer. The US District Court for the District of Delaware has found both the patents ...
Tags: Astellas Pharma, Mylan, lawsuit
Watson Pharmaceuticals has confirmed favorable US District Court for the District of Delaware ruling in generic Sanctura XR (trospium chloride extended-release capsules) patent suit. The Court has ruled that the asserted claims of US ...
Tags: treatment of overactive bladder, pharmaceutical product
Horizon Pharma has filed a patent infringement lawsuit in the US District Court for the District of Delaware against Par Pharmaceutical. The suit is related to an abbreviated new drug application that Par filed with the FDA to market ...
Tags: Patent, Lawsuit, drug application