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Generic Version
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Packaging Defects Prompted a Recall of a Combination Cholesterol Drug Called Liptruzet
Jan 16, 2014Packaging defects have prompted a recall of a combination cholesterol drug called Liptruzet, produced by Merck & Co., temporarily affecting the entire U.S. stock. Merck said the foil pouches holding Liptruzet pills could allow air and ...
Tags: recall, Liptruzet, Merck, packaging defects
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Packaging Defects Prompted a Recall of a Combination Cholesterol Drug Called Liptruzet
Jan 15, 2014Packaging defects have prompted a recall of a combination cholesterol drug called Liptruzet, produced by Merck & Co., temporarily affecting the entire U.S. stock. Merck said the foil pouches holding Liptruzet pills could allow air and ...
Tags: Drug, Health, Medicine, Drug Packaging, Packaging
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Mylan Announced That Its U.S. Has Launched Mycophenolic Acid Delayed-Release Tablets
Jan 10, 2014Mylan 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® ...
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Actavis Plc Has Received Approval From The U.S. FDA on ANDA
Jan 10, 2014Actavis 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 ...
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Actavis PLC Would Prevent Actavis From Commercializing Its Anda Product Prior
Dec 30, 2013Actavis 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
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Warner Chilcott Has Filed an ANDA with The U.S. FDA Seeking Approval
Dec 30, 2013Today 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 ...
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Pfizer Has Settled Its Litigation Against Teva Pharmaceuticals,USA Inc.
Dec 20, 2013Pfizer Inc. announced that it has settled its litigation against Teva Pharmaceuticals, USA Inc., relating to Pfizer's patent covering the use of Viagra? to treat erectile dysfunction (sildenafil citrate 25, 50, and 100 mg tablets), which ...
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Mylan Today Announced That Subsidiary Mylan Pharmaceuticals and Partner,Banner Pharmacaps
Dec 19, 2013Mylan 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
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US District Court for The District of Delaware Upheld The Validity of a Patent
Dec 19, 2013GSK and ViiV Healthcare confirmed today that the US District Court for the District of Delaware upheld the validity of a patent covering the double combination of? lamivudine and abacavir (Epzicom?) and the triple combination of lamivudine, ...
Tags: GSK, ViiV, Lupin Generic, Trizivir Patent
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FDA Has Granted Final Approval of The Company's Dexmethylphenidate Hydrochloride
Nov 20, 2013Intellipharmaceutics International has announced that the US Food and Drug Administration (FDA) has granted final approval of the company's dexmethylphenidate hydrochloride extended-release capsules for the 15 and 30mg strengths. ...
Tags: Focalin XR, Medicine
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INSV Has Reported The US District Court Upheld All Four of The Patents Protecting AzaSite
Oct 10, 2013InSite 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 ...
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Par Pharmaceutical Has Received Final Approval From FDA for Its Anda for Clonidine HCl ER
Oct 10, 2013US-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
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Mylan Pharmaceuticals Has Introduced Voriconazole for Oral Suspension
Oct 8, 2013Mylan 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
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FDA Laid out The Kind of Scientific Studies Generic Companies Need to Submit
Sep 12, 2013One of the world's top-selling drugs—GlaxoSmithKline PLC's $8-billion-a-year asthma treatment Advair—became more vulnerable to generic competition after the U.S. Food and Drug Administration issued guidance on the regulatory ...
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AVNR Has Entered Into a Settlement Agreement with The US Unit
Sep 10, 2013US-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
