Generics Industry News Search
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May 2010 News Archive |
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Par Pharmaceutical Companies, Inc. today announced that its generic division, Par Pharmaceutical, has entered into an exclusive licensing agreement with Glenmark Generics Limited and Glenmark Generics Inc., USA to market ezetimibe 10 mg tablets, the generic version of Merck & Co. Inc.'s Zetia, in the U.S. ...
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Glenmark Pharmaceuticals S.A (GPSA), a wholly owned subsidiary of Glenmark Pharmaceuticals Limited India (GPL), announced today that it has entered into an agreement with Sanofi-Aventis to grant Sanofi-Aventis a license for the development and commercialization of novel agents to treat chronic pain....
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Mylan Inc. today announced that its subsidiary Mylan Pharmaceuticals Inc. received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application for Bupropion Hydrochloride Extended-release Tablets USP (SR), 150 mg, the generic version of GlaxoSmithKline's smoking cessation aid, Zyban(R)....
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Sandoz has launched a generic version of a prostate drug, the generics arm of Novartis said Monday...
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Perrigo today announced that it has acquired the exclusive U.S. store brand rights to sell and distribute Dextromehtorphan Polistirex Extended Release Suspension Cough Suppressant, the generic version of Reckitt Benckiser's Delsym(R) from Tris Pharma....
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The Chennai-based global pharma major, Orchid Chemicals & Pharmaceuticals Ltd., (Orchid), today announced that it has entered into an out-licensing and distribution agreement with US-based pharma major Alvogen for marketing 8 of Orchid's Oral non-antibiotic generic formulations in the US market....
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Watson Pharmaceuticals, Inc. today confirmed that its subsidiary, Watson Laboratories, Inc. - Florida, filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market its 1000 mg/20 mg form of niacin extended-release/simvastatin tablets....
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Watson Pharmaceuticals, Inc. today confirmed that its subsidiary, Watson Laboratories, Inc. filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market a raloxifene hydrochloride tablet. Watson's raloxifene hydrochloride tablet is a generic version of Eli Lilly's EVISTA(R)....
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Sandoz has launched a generic antibiotic for pneumonia and acute sinus infections, the generics arm of Swiss drug maker Novartis said Tuesday...
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Mylan Pharmaceuticals ULC today announces it has launched Mylan-Nifedipine Extended Release tablets in 30 mg strength...
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Glenmark Generics Inc., USA, a wholly owned subsidiary of Glenmark Generics Ltd Limited, India, today announced that it has entered into an exclusive license and supply agreement for a branded product with Taro Pharmaceuticals...
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Intellipharmaceutics International Inc. and its wholly owned subsidiary Intellipharmaceutics Corp. today announced that it and its licensee and development partner Par Pharmaceutical, Inc. have received confirmation that the previously announced stays of the patent litigation concerning a generic version of Novartis' Attention Deficit Hyperactivity Disorder drug, Focalin XR(R), (dexmethylphenidate hydrochloride), have expired without regulatory intervention, and that the parties have stipulated to a dismissal of the litigation...
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Sun Pharmaceutical Industries Ltd. announced that USFDA has granted its subsidiary an approval for its Abbreviated New Drug Application (ANDA) to market a generic version of Forest Laboratories, Inc.'s Namenda 5 mg and 10 mg tablets....
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Watson Pharmaceuticals, Inc. today announced that its subsidiary, Watson Laboratories, Inc. has reached a settlement with Teva Women's Health, Inc. on outstanding patent litigation related to Teva's Seasonale(R)...
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Intellipharmaceutics International Inc., today announced that the Food and Drug Administration has accepted for filing its abbreviated new drug application for a generic version of the antidepressant Effexor XR(R) (venlafaxine hydrochloride)...
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Sanofi-Aventis Canada said it is shedding nearly 70 jobs in its Canadian operations as part of a reorganisation aimed at addressing challenges from the loss of patent exclusivity...
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Valeant Pharmaceuticals International today announced that its wholly owned subsidiary, Valeant Canada Limited, has received notice that the New Drug Submission for Onsolis (fentanyl buccal soluble film) has been approved from the Canadian regulatory authority Health Canada....
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Glenmark Generics, an arm of Glenmark Pharmaceuticals, has received nod from the US Food and Drug Administration for Abbott's Tarka generic...
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Merck & Co., Inc. and Glenmark Pharmaceuticals Inc., USA and Glenmark Pharmaceuticals, Ltd. have reached an agreement to settle their patent litigation involving Glenmark's challenge to Merck's patent covering ZETIA(R) (ezetimibe)...
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Alembic has received an approval from the United States Food and Drug Administration (USFDA) to market Metronidazole Tablets in strength of 750 mg....
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Further strengthening its global competitive position, Abbott today announced a licensing and supply agreement with Zydus Cadila of India for a portfolio of pharmaceutical products that Abbott will commercialise in 15 emerging markets...
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Merck, one of Big Pharma's pioneers in the development of rival versions of popular biotech drugs, told analysts today that it had canceled one of its first forays into the potentially lucrative area...
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Ranbaxy has reached an out-of-court settlement with Medicis on acne drug Solodyn (minocycline hydrochloride) last week...
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Strides Arcolab Limited (Strides) today announced that the U.S. Food and Drug Administration had granted approval of Bacitracin for injection, USP (Bacitracin), an anti-infective product used to treat pneumonia and empyema. Bacitracin will be offered in a 50,000 MU, AP-rated, preservative-free, latex-free, single-dose vial packaged both individually and in packages of ten....
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Strengthening the collaboration announced earlier this year, Strides Arcolab today announced the signing of two licensing and supply agreements with Pfizer Inc. to address new markets and product segments...
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Aurobindo Pharma has received tentative approval for Rosuvastatin calcium tablets 5mg, 10 mg, 20mg and 40 mg from the US FDA. Rosuvastatin calcium tablets are the generic equivalent of IPR Pharmaceuticals Inc's Crestor tablets 5mg, 10 mg, 20mg and 40 mg....
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Strides Arcolab today announced that US FDA has granted approval of Vecuronium Bromide for Injection, 10 mg per vial and 20mg per vial, a neuromuscular blocking agent of intermediate duration is used as an adjunct to general anesthesia....
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Shire plc, the global specialty biopharmaceutical company, announces that its subsidiary Shire LLC has filed a lawsuit in the U.S. District Court for the District of Delaware against Actavis Elizabeth LLC and Actavis Inc. for the infringement...
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Teva Pharmaceutical Industries Ltd. announced today that the U.S. Food and Drug Administration (FDA) has granted tentative approval for the Company's Abbreviated New Drug Application (ANDA) for Cinacalcet HCl Tablets 30, 60 & 90 mg....
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India's Dr Reddy's Laboratories has received U.S. regulator's approval to launch tacrolimus capsules, used to help prevent rejection of kidney and liver transplants...
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Impax Laboratories, Inc today confirmed that the U.S. Food and Drug Administration has granted tentative approval of the Company's Abbreviated New Drug Application for generic version of Opana(R) ER (oxymorphone hydrochloride)...
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The US Food and Drug Administration has once again rejected Teva Pharmaceutical Industries' request to stop approval of any generic versions of the Israeli company's multiple sclerosis blockbuster Copaxone...
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Teva Pharmaceutical Industries Ltd. announced today that it has entered into an agreement with AstraZeneca to settle patent litigation regarding Teva's U.S. generic version of AstraZeneca's Entocort EC (budesonide) capsules....
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Strides Arcolab Limited (Strides) announced today that it has received tentative approval from the United States Food and Drug Administration for abbreviated new drug application (ANDA) for Abacavir Sulfate Tablets, 300mg under the expedited review provisions of the President’s Emergency Plant for AIDS Relief (PEPFAR)....
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A federal judge has dismissed Wyeth, Inc. and Schwarz Pharma, Inc. from a metoclopramide lawsuit filed in Texas over the development of the movement disorder tardive dyskinesia, as plaintiff never used the name brand medication Reglan sold by the drug makers...
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Teva Pharmaceutical Industries Ltd. announced today that its subsidiary, Teva Canada received a Notice of Compliance from Health Canada to market its generic version of Pfizer's Lipitor (atorvastatin) Tablets, a product indicated for lowering cholesterol. Shipment of this product will commence immediately....
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Watson Pharmaceuticals, Inc. today announced that its subsidiary Cobalt Pharmaceuticals has received a Notice of Compliance from Health Canada to market Atorvastatin Calcium Tablets in the 10, 20, 40 and 80 mg strengths. Watson has initiated shipments of this product....
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Sandoz today announced the launch in the US of the first generic version of metaxalone tablets, a generic equivalent of Skelaxin(R), enjoying 180-day ANDA exclusivity. Metaxalone is a leading muscle relaxant used to treat acute skeletal muscle conditions, such as lower back spasms caused by injury, in combination with rest and physical therapy....
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Medicis Pharmaceutical Corp., a maker of acne and wrinkle treatments, sued Nycomed GmbH to block sales of a generic form of its Vanos steroid-based skin ointment....
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Abbott announced a definitive agreement with Piramal Healthcare Limited to acquire full ownership of Piramal's Healthcare Solutions business (Domestic Formulations), a leader in the Indian branded generics market, for an up-front payment of $2.12 billion, plus $400 million annually for the next four years, giving Abbott the No. 1 position in the Indian pharmaceutical market....
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Patent Docs: (Court Report) - May 23, 2010 By Sherri Oslick - About Court Report: Each week we will report briefly on recently filed biotech and pharma cases....
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Watson Pharmaceuticals, Inc., today announced that its subsidiary, Watson Laboratories, Inc., has received approval from the United States Food and Drug Administration on its Abbreviated New Drug Application (ANDA) for Valacyclovir Hydrochloride tablets, USP, in the 500 and 1000 mg strengths, the generic equivalent to GlaxoSmithKline, LLC's VALTREX(R) tablets....
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Elite Pharmaceuticals, Inc. announced today the acquisition of a currently approved Abbreviated New Drug Application (ANDA) for hydromorphone hydrochloride 8 mg tablets from Mikah Pharma LLC. The hydromorphone hydrochloride tablets are the generic equivalent of Dilaudid(R) 8 mg....
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When a feisty Indian generics company took on GlaxoSmithKline in its home market six years ago it won the first battle in a continuing war for one of the UK drug group's most lucrative products....
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SOHM, Inc., a generic pharmaceutical manufacturer that produces and markets generic drugs covering all major treatment categories, announced today that the Company has received a purchase order for protein-based nutraceutical products in India....
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Danish company Novo Nordisk has sued Mumbai-based drugmaker Lupin to prevent it from launching the low priced version of its patented diabetes medicine sold under the brand Prandimet in US....
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Israel's Teva Pharmaceutical Industries is developing a generic version of Roche's blockbuster antibody drug Rituxan, highlighting the race to produce so-called biosimilar medicines...
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Watson Pharmaceuticals, Inc. today confirmed that its subsidiary, Watson Laboratories, Inc. filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market sevelamer carbonate 800mg tablets....
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A pharmaceutical company wants to thwart Mylan's attempts to produce and market a generic version of its patented drug....
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Aspen shareholders are advised that Aspen has submitted an indicative non-binding proposal to acquire, either directly or through a wholly-owned subsidiary, Sigma Pharmaceuticals Limited...
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Mylan Inc. today announced that its subsidiary Mylan Pharmaceuticals Inc. has launched Temazepam Capsules USP, 7.5 mg....
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Genzyme Corp has sued Sandoz Inc, accusing it of infringing the patent for its Hectorol drug which is approved for controlling hormone production in patients with kidney disease....
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The UK's National Institute for Health and Clinical Excellence (NICE) today published final guidance on the relative cost and effectiveness of somatropin products to treat child growth deficiencies....
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Perrigo Company today announced that it has acquired rights to Novel Laboratories' pending ANDA for HalfLytely and Bisacodyl Tablets Bowel Prep Kit (PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution and bisacodyl delayed-release tablets), indicated for the cleansing of the colon as a preparation for colonoscopy in adults....
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French drugmaker Sanofi-Aventis will form a capital and operational tie-up with Nichi-Iko Pharmaceutical Co as part of a foray into the Japanese generic-drug market, the Nikkei business daily reported on Thursday....
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Celgene Corporation announced that as a result of Barr Laboratories, Inc., withdrawing its Abbreviated New Drug Application (ANDA) for Thalidomide with the US Food and Drug Administration, the US District Court for the District of New Jersey has granted the requested dismissal of all claims and counterclaims in the Thalidomide patent cases....
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Shire plc, the global specialty biopharmaceutical company, announces that it has received a Paragraph IV Notice Letter today from Zydus Pharmaceuticals USA, Inc. ("Zydus") advising of the filing of an Abbreviated New Drug Application ("ANDA") for a generic version of Shire's 1.2g Mesalamine delayed release tablets, LIALDA....
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A federal court has ruled that Mylan Pharmaceuticals' proposed generic version of the prostate treatment Uroxatral would infringe and induce others to infringe Sanofi-Aventis' patent on the drug....
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The drug maker Teva says it won't make any more of its sedative Propofol, which could intensify a shortage of an anaesthetic widely used in operating rooms....
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