Hi-Tech Pharmacal Co., Inc. (NASDAQ:HITK), a specialty pharmaceuticals company, announced today that the US Food and Drug Administration, (FDA) granted final approval for the Company's Abbreviated New Drug Application, (ANDA) for Bromfenac ...
Mylan Inc. (Nasdaq: MYL) today announced that its U.S.-based subsidiary Mylan Pharmaceuticals Inc. has launched Mycophenolic Acid Delayed-release Tablets, 180 mg and 360 mg. This product is the generic version of Novartis' Myfortic® ...
Actavis plc (NYSE: ACT) today announced that it has received approval from the U.S. Food and Drug Administration (FDA) on its Abbreviated New Drug Application (ANDA) for Telmisartan Immediate-Release Tablets, 20 mg, 40 mg and 80 mg, a ...
Actavis plc (NYSE: ACT) today confirmed that its subsidiary, Warner Chilcott Company LLC, has filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market Ethinyl Estradiol and ...
Tags: Actavis, Warner Chilcott Company LLC, Abbreviated New Drug Application
Today confirmed that its subsidiary, Warner Chilcott Company LLC, has filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market Ethinyl Estradiol and Etonogestrel Vaginal ...
Mylan Inc. (Nasdaq: MYL) today announced that its subsidiary Mylan Pharmaceuticals Inc. and partner, Banner Pharmacaps Inc. (a wholly-owned subsidiary of Patheon Inc.), have entered into a settlement and license agreement with Eisai Inc. ...
Tags: Mylan, Targretin Suit, Treatment of Cutaneous Manifestations
InSite Vision Incorporated (INSV) has reported that the US District Court for the District of New Jersey upheld all four of the patents protecting AzaSite, an azithromycin 1% ophthalmic solution, in a patent infringement lawsuit against ...
US-based specialty pharmaceutical firm Par Pharmaceutical has received final approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for clonidine hydrochloride (HCl) extended-release (ER) ...
Tags: Par Pharmaceutical, Medicine
Mylan Pharmaceuticals, a subsidiary of Mylan, has introduced Voriconazole for oral suspension, 40 mg/mL, which is the first generic version of Pfizer's VFEND for oral suspension. The US Food and Drug Administration (FDA) has granted a ...
Tags: Mylan, Antifungal Drug
US-based Avanir Pharmaceuticals (AVNR) has entered into a settlement agreement with the US unit of Indian drugmaker Wockhardt to resolve pending patent litigation in response to Wockhardt's abbreviated new drug application (ANDA) seeking ...
Tags: Avanir Pharma, Medicine
Mylan has obtained FDA approval for its supplemental abbreviated new drug application (sANDA) for the generic version of GSK's WELLBUTRIN XL, bupropion hydrochloride extended-release tablets USP (XL), 300mg. Bioequivalence study results ...
Tags: FDA Approval, drug application
Avanir Pharmaceuticals has settled pending patent litigation concerning Sandoz's abbreviated new drug application (ANDA) to market generic versions of Avanir's Nuedexta (dextromethorphan hydrobromide/quinidine sulfate) capsules. Under the ...
Tags: Avanir Pharmaceuticals
ANI Pharmaceuticals has signed a binding letter of intent with Sofgen Pharmaceuticals to develop and market an oral soft gel prescription product indicated for cardiovascular health. Development, manufacturing and regulatory activities of ...
Perrigo Company has received final FDA approval for abbreviated new drug application for generic equivalent to cutivate lotion, 0.05% and begins immediate shipment of the product. Cutivate Lotion 0.05% (fluticasone propionate lotion, ...
Dr Reddy's Laboratories, an India-based pharmaceutical company, has introduced Donepezil Hydrochloride tablets 23mg in the US on 26 July 2013. The launch follows the approval of an abbreviated new drug application (ANDA) for the drug by ...
Tags: Drug Aricept, Generic Equivalent