Generics Industry News Search
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August 2005 News Archive |
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Watson Pharmaceuticals, Inc. (NYSE: WPI), a leading specialty pharmaceutical company, announced today that it has received final approval from the United States (U.S.) Food and Drug Administration (FDA)...
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Ranbaxy Malaysia Sdn. Bhd (RMSB), a subsidiary of Ranbaxy Laboratories Limited (RLL) today announced the commissioning of its new state-of-the-art manufacturing facility in Sungai Petani,Kedah, Malaysia....
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The Chennai-based pharma major, Orchid Chemicals & Pharmaceuticals Ltd. (Orchid) today announced that it has received the formal approval from the USFDA for its generic Ceftriaxone ANDA (Abbreviated New Drug Application). ...
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Ranbaxy Laboratories Limited (RLL), announced today that the Company has received tentative approval from the U.S. Food and Drug Administration to manufacture and market Sumatriptan Succinate Tablets...
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Taro Pharmaceutical Industries Ltd. (Nasdaq: TARO) reported today that it has received approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application for Hydrocortisone Butyrate Cream USP, 0.1% (hydrocortisone butyrate cream)....
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Taro Pharmaceutical Industries Ltd. (Nasdaq:TARO) reported today that Taro Pharmaceuticals U.S.A., Inc. has received approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application for Halobetasol Propionate Cream, ...
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Merck KGaA announced today that it has established a generic pharmaceuticals business, Genpharm, L.P., in New York to provide direct access to customers in the United States. ...
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Lupin Limited and Kyowa Pharmaceutical Industry Co. Ltd., Japan announced today that they have entered into agreements through which the two will cooperate to market finished formulations in Japan. ...
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Taro Pharmaceutical Industries Ltd. reported today that Taro Pharmaceuticals U.S.A., Inc. (Taro USA) has received approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application for Ciclopirox ...
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Ranbaxy Laboratories Limited (Ranbaxy) announced today that the World Health Organisation (WHO), Geneva, has included the Company’s seven Anti Retrovirals (ARVs) in its pre-qualification list....
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A U.S. appeals court on Thursday reversed a finding of summary judgment in favor of Pfizer Inc. for a patent on its Accupril drug to treat high blood pressure, sending the case back for further review. ...
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United Research Laboratories and Mutual Pharmaceutical Company today announced that Mutual Pharmaceutical has received FDA approval of its Abbreviated New Drug Application (ANDA) for Butalbital 50mg/Acetaminophen 325mg/Caffeine 40mg tablets....
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Barr Pharmaceuticals, Inc. today announced that its subsidiary, Barr Laboratories, Inc., has received final approval from the U.S. Food and Drug Administration (FDA) for its application to manufacture and market Clonazepam Orally Disintegrating Tablets,...
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Generics Remain Outstanding Value; Brand Price Increases Outpacing Inflation...
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Teva Pharmaceutical Industries Ltd. announced today that the U.S. Food and Drug Administration has granted final approval for the Company’s ANDA for Paroxetine Hydrochloride Tablets, 10 mg, 20 mg, 30 mg and 40 mg. Shipment of this product is expected to begin immediately.
Teva’s Paroxetine HCl Tablets are the AB-rated generic equivalent of GlaxoSmithKline’s antidepressant Paxil® Tablets. ...
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KV Pharmaceutical Company announced today that it has received notification of approvals to market Gynazole-1® from one of its international licensees, Gedeon Richter, Ltd....
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Teva Pharmaceutical Industries Ltd. announced today that the U.S. Food and Drug Administration has granted tentative approval for the Company’s ANDAs for Granisetron HCl Injection, 1 mg/mL single dose vials and Granisetron HCl Injection,...
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Barr Pharmaceuticals, Inc. today confirmed that the U.S. Food and Drug Administration (FDA) has issued an Approvable letter for Duramed Pharmaceuticals, Inc.'s New Drug Application (NDA) for SEASONIQUE(TM)...
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Teva Pharmaceutical Industries Ltd. announced today that the U.S. Food and Drug Administration has granted tentative approval for the Company’s ANDAs for Granisetron HCl Injection, 1 mg/mL single dose vials and Granisetron HCl Injection, 4 mg/4mL in multi-dose vials....
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Sigma and Arrow today announced an agreed proposal to merge their businesses to create the leading Australian-owned pharmaceutical company.
The merger of Sigma and Arrow will create a substantial Australian pharmaceutical business focused on eeting the healthcare needs of Australians. The new Sigma group will have an extensive suite of pharmaceutical products covering branded prescription, generic pharmaceuticals and OTC products....
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Alpharma Inc. today announced that the U.S. District Court for the District of New Jersey ruled in Alpharma’s favor on a joint motion for summary judgment filed by the defendants, Alpharma, Teva, Ivax, Apotex, and Eon, ...
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Caraco Pharmaceutical Laboratories, Ltd. announced today that the US Food and Drug Administration (FDA) has granted tentative approval for the Company's ANDA for Zolpidem Tartrate, 5mg and 10mg tablets....
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Caraco Pharmaceutical Laboratories, Ltd., announced today that the US Food and Drug Administration (FDA) has granted another approval for the Company's ANDA for Clozapine 50 mg tablets....
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he Perrigo Company today announced that, through a partnership with InvaGen Pharmaceuticals, it has received tentative approval from the U.S. Food and Drug Administration (FDA) to market Glimepiride Tablets, 1 mg, 2 mg and 4 mg. ...
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Mylan Laboratories Inc. today announced that Mylan Pharmaceuticals Inc. has received tentative approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Ondansetron Hydrochloride Tablets, 4 mg, 8 mg, 16 mg, and 24 mg. ...
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Baxter Healthcare Corporation announced today that it has received approval from the U.S. Food and Drug Administration (FDA) for Ceftriaxone Injection, USP 1g/50 mL and 2g/50 mL packaged in single-dose plastic containers. Baxter, the only company to offer frozen premixed drugs, ...
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Par Pharmaceutical Companies Inc. today announced that it has received final approval from the U.S. Food and Drug Administration for its abbreviated New Drug Applications for cholestyramine for oral suspension,...
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Momenta Pharmaceuticals, Inc., announced today that an Abbreviated New Drug Application (ANDA) seeking marketing approval of M-Enoxaparin has been filed with the United States Food and Drug Administration (FDA). ...
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Spectrum Pharmaceuticals, Inc. announced that it has filed its twelfth Abbreviated New Drug Application (ANDA), with the U.S. Food and Drug Administration (FDA)....
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