Dr. Reddy's Laboratories, an integrated global pharmaceutical company, has introduced Ibandronate Sodium tablets (150mg) in the US, following FDA approval of the product's ANDA. The product, Ibandronate Sodium tablets (150mg), is the ...
Tags: ibandronate sodium tablets, Boniva, Dr.Reddy's Laboratories
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 ...
Dr. Reddy's Laboratories, an integrated pharmaceutical company, has introduced Ropinirole Hydrochloride XR (extended-release) tablets of strengths 2mg, 4mg, 6mg, 8mg, and 12mg. The launch was followed by the approval of Dr. Reddy's ANDA ...
Tags: Generic Requip Xl Tablets, REQUIP XL tablets, pharmaceutical
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' ...
Wockhardt has received final approval from the US Food and Drug Administration ((FDA) to market extended-release tablets containing 2.5mg, 5mg and 10mg Felodipine, which are used to treat hypertension. Felodipine is the generic name for ...
Watson Pharmaceuticals has introduced Pioglitazone Hydrochloride 15mg, 30mg and 45mg tablets, a generic equivalent to Actos. The company began the shipment of the product after winning the final FDA approval. Actos is a prescription ...
Tags: Generic Version, Actos, blood sugar
Meridian Medical Technologies,a Pfizer subsidiary,and Teva have entered into a settlement agreement to resolve generic epinephrine auto-injector pending patent litigation. Under the terms of the agreement,Teva may launch a generic ...
Tags: Epinephrine Auto, Meridian, Teva, generic epinephrine auto-injector
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 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