Roxane Lab Announced the Launch of Acarbose Tablets
Roxane Lab. announced the approval of their ANDA for Acarbose Tablets, 25mg, 50mg, and 100mg. The product is available in bottles of 100 tablets for all strengths as well as Unit Dose Blisters for the 50mg strength and is available for immediate shipment to wholesalers and pharmacies nationwide
Mylan and Teva Introduces Ropinirole Hydrochloride Tablets
Mylan and Teva Pharma announced the introduction and availability of Ropinirole Hydrochloride Tablets. This product is AB rated and bioequivalent to Requip Tablets. Ropinirole HCl Tablets are available in 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, and 4 mg strengths, in bottle sizes of 100
Amneal got USFDA Approval for Three Generic Prescription Drugs
Roxane Lab. announced the approval of their ANDA for Acarbose Tablets, 25mg, 50mg, and 100mg. The product is available in bottles of 100 tablets for all strengths as well as Unit Dose Blisters for the 50mg strength and is available for immediate shipment to wholesalers and pharmacies nationwide
Mylan and Teva Introduces Ropinirole Hydrochloride Tablets
Mylan and Teva Pharma announced the introduction and availability of Ropinirole Hydrochloride Tablets. This product is AB rated and bioequivalent to Requip Tablets. Ropinirole HCl Tablets are available in 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, and 4 mg strengths, in bottle sizes of 100
Amneal got USFDA Approval for Three Generic Prescription Drugs
Amneal Pharma announced that it has received USFDA approval to manufacture Primidone Tablets (50/250mg), Cyclobenzaprine Tablets (10mg) and Demeclocycline Tablets (150/300mg) within the last several weeks. Two of these products were filed during 2007 using the FDA's evolutionary electronic dossier submission 9e-CTD) format that enabled approvals in less than twelve months
Sepracor Announces Final Settlement of Xopenex Inhalation Solution Patent Infringement Litigation
Sepracor announced that it has entered into a Settlement and License Agreement with Breath Limited (Breath), an Arrow Group subsidiary, to resolve the patent litigation involving Sepracor's Xopenex brand levalbuterol HCl Inhalation Solution products (1.25 mg/3 mL, 0.63 mg/3 mL and 0.31 mg/3 mL). The agreement permits Breath to launch generic versions of these Xopenex Inhalation Solution dosages under terms of an exclusive license commencing on August 20, 2012.
Teva Introduces Epoprostenol Sodium for Injection
Teva Pharma announced that the USFDA has granted approval to its ANDA to market Epoprostenol, a generic version of GlaxoSmithKline’s Flolan® for Injection
Mylan Announces Final FDA Approval for Trandolapril Tablets
Mylan got final approval from the USFDA for its ANDA for Trandolapril Tablets, 1 mg, 2 mg and 4 mg.
Ohm Lab (Ranbaxy subsidry) got Final Approval to Manufacture and Market Cetirizine Hydrochloride Oral Solution
Ohm Lab (Ranbaxy subsidry) announced that it has received final approval from the USFDA to manufacture and market Cetirizine Hydrochloride Oral Solution (Allergy) and Children's Cetirizine Hydrochloride Oral Solution (Hives-Relief), 1 mg/mL (OTC).
Sepracor Announces Final Settlement of Xopenex Inhalation Solution Patent Infringement Litigation
Sepracor announced that it has entered into a Settlement and License Agreement with Breath Limited (Breath), an Arrow Group subsidiary, to resolve the patent litigation involving Sepracor's Xopenex brand levalbuterol HCl Inhalation Solution products (1.25 mg/3 mL, 0.63 mg/3 mL and 0.31 mg/3 mL). The agreement permits Breath to launch generic versions of these Xopenex Inhalation Solution dosages under terms of an exclusive license commencing on August 20, 2012.
Teva Introduces Epoprostenol Sodium for Injection
Teva Pharma announced that the USFDA has granted approval to its ANDA to market Epoprostenol, a generic version of GlaxoSmithKline’s Flolan® for Injection
Mylan Announces Final FDA Approval for Trandolapril Tablets
Mylan got final approval from the USFDA for its ANDA for Trandolapril Tablets, 1 mg, 2 mg and 4 mg.
Ohm Lab (Ranbaxy subsidry) got Final Approval to Manufacture and Market Cetirizine Hydrochloride Oral Solution
Ohm Lab (Ranbaxy subsidry) announced that it has received final approval from the USFDA to manufacture and market Cetirizine Hydrochloride Oral Solution (Allergy) and Children's Cetirizine Hydrochloride Oral Solution (Hives-Relief), 1 mg/mL (OTC).
