Mylan Institutional business has won final FDA approval for its abbreviated new drug application (ANDA) for preservative-free Thiamine Hydrochloride Injection, 100mg/ml, packaged in 200mg/2ml multiple-dose vials. Mylan is shipping the ...
Perrigo Company has received final FDA approval for its abbreviated new drug application (ANDA) for clindamycin phosphate and benzoyl peroxide 1.2% / 5% topical gel, the generic equivalent of Duac gel. Duac Gel is indicated for the ...
Tags: perrigo company, ANDA, patent litigation
Mylan Pharmaceuticals has received final FDA approval for its abbreviated new drug application (ANDA) for Lithium Carbonate Extended-release tablets USP, 300mg. Mylan has announced immediate shipment of the generic version of Noven ...
Tags: new drug, Lithium Carbonate Extended-release tablets USP, manic episodes
Mylan Pharmaceuticals has won final FDA approval for its abbreviated new drug application (ANDA) for Pioglitazone tablets USP, 15mg, 30mg and 45mg. Previously, FDA has also approved the company's ANDA for Pioglitazone Hydrochloride and ...
Mylan Pharmaceuticals has introduced the generic version of Schering-Plough's Clarinex allergy medication, Desloratadine tablets, 5mg. Mylan gained final FDA approval for its abbreviated new drug application for Desloratadine Tablets, ...
Tags: Generic Clarinex Tablets, Desloratadine tablets, drug applications
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
The US Food and Drug Administration's (FDA) Center For Drug Evaluation and Research has issued new guidelines for the packaging of test batches manufactured for Abbreviated New Drug Applications (ANDA), Abbreviated Antibiotic Applications ...
Tags: FDA, food, drug, packaging, test batches, ANDA, labeling
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