Mylan Pharmaceuticals has gained final FDA approval for its abbreviated new drug application (ANDA) for Fluvastatin Capsules USP, 20mg and 40mg, and began shipment of the product. The product, a generic version of Novartis' Lescol ...
Mylan Pharmaceuticals has won final FDA approval for its abbreviated new drug application (ANDA) of Itraconazole capsules, 100mg, the generic version of Janssen Pharmaceutical's Sporanox capsules. The generic Sporanox is indicated for the ...
US based Watson Pharmaceuticals has filed a legal case against US Food and Drug Administration's (FDA) decision regarding the company's exclusivity for its generic version of Actos (Pioglitazone Hydrochloride 15mg, 30mg and 45mg tablets). ...
Tags: Watson Pharmaceuticals, Actos, Pioglitazone Hydrochloride
Watson Laboratories, a subsidiary of Watson Pharmaceuticals, has won FDA abbreviated new drug application approval for Diclofenac Sodium and Misoprostol Delayed-Release Tablets. The company plans to launch Diclofenac Sodium and ...
Tags: Watson Laboratories
Perrigo Company, a healthcare company, has won final FDA approval for its abbreviated new drug application for morphine sulfate 100ml/5% oral solution. Perrigo will immediately begin the shipment of Morphine sulfate oral solution, a ...
Tags: Perrigo Company, morphine sulfate, morphine sulfate oral solution
America's Impax Laboratories has begun the challenging process against the suit filed by two companies for patent infringement over a generic version of Opana® ER (oxymorphone hydrochloride extended-release) drug. Impax ...
Watson Laboratories, a subsidiary of Watson Pharmaceuticals, has gained FDA abbreviated new drug application (ANDA) approval for Next Choice ONE DOSE (Levonorgestrel Tablet, 1.5mg). The Next Choice ONE DOSE (Levonorgestrel Tablet, 1.5mg) ...
Tags: ONE DOSE, levonorgestrel tablet, Watson Pharmaceuticals
Watson Laboratories, a subsidiary of Watson Pharmaceuticals, has received FDA approval for its abbreviated new drug application (ANDA) of Trospium Chloride Extended-release Capsules. Watson anticipates beginning the shipment of the ...
Tags: FDA, Trospium Chloride Extended-release Capsules, pharmaceutical product
Mylan Pharmaceuticals has gained final FDA approval for its abbreviated new drug application (ANDA) for Nevirapine Tablets USP, 200mg and initiated the shipment of the product. The generic version of Boehringer Ingelheim's Viramune is ...
Tags: Mylan pharmaceuticals, ANDA, ARV
Mylan's subsidiary, Mylan Pharmaceuticals, has settled Provigil litigation with Teva Pharmaceutical USA. The settlement follows the Mylan litiagtion against the US Food and Drug Administration (FDA) regarding Mylan's abbreviated new drug ...
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