Mylan and its subsidiary, Mylan Pharmaceuticals, have signed a settlement agreement with Pfizer, Pharmacia & Upjohn Company and Pfizer Health related to Detrol LA patent litigation. The litigation is related to Mylan Pharmaceuticals' ...
Mylan Pharmaceuticals has won final FDA approval for its abbreviated new drug application for Olanzapine tablets USP, 2.5mg, 5mg, 7.5mg, 10mg, 15mg, and 20mg. The company begins the shipment of the product, which is the generic equivalent ...
Tags: Generic Zyprexa Tablets, Mylan Pharmaceuticals, new drug
APP Pharmaceuticals, a Fresenius Kabi Company, has purchased three products, Benztropine Mesylate Injection, Levetiracetam Injection and Tranexamic Acid Injection, from Nexus Pharmaceuticals. As per the agreement, APP acquires complete ...
The FDA has approved Mylan Pharmaceuticals' abbreviated new drug application (ANDA) for Clopidogrel tablets USP, 75mg and 300mg. The generic version of Sanofi-Aventis' Plavix is indicated for acute coronary syndrome and for patients with ...
Tags: Clopidogrel Tablets, Mylan Pharmaceuticals, drug application
Watson Laboratories,a subsidiary of Watson Pharmaceuticals,has won FDA approval for its abbreviated new drug application(ANDA)for Budesonide inhalation suspension 0.25mg/2mL and 0.5mg/2mL unit-dose ampoules. Budesonide Inhalation ...
Sun Pharmaceutical Industries has received FDA approval for its abbreviated new drug application (ANDA) of Azelastine HCL nasal spray, 0.1% (137mcg/spray). The generic equivalent to Medpointe Pharm's Astelin nasal spray is indicated to ...
Tags: Sun Pharmaceutical Industries, Azelastine HCL nasal spray, Medicine
Mylan has reached a settlement in a patent litigation suit filed by Sunovion Pharmaceuticals concerning Mylan Specialty's abbreviated new drug application for Levalbuterol Hydrochloride (HCl) Inhalation Solution, 0.31mg/3 mL, 0.63mg/3 mL, ...
Tags: Sunovion Pharmaceuticals, Medicine
Mylan Laboratories, formerly Matrix Laboratories, has gained final FDA approval for its abbreviated new drug application (ANDA) of Atorvastatin Calcium Tablets of strengths 10mg, 20mg, 40mg and 80mg. The company begins immediate shipment ...
Tags: Generic Lipitor Anda, drug application, Atorvastatin Calcium Tablets
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