Generics Industry News Search
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July 2005 News Archive |
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Actavis Group has introduced a new generic product to the German market, through its subsidiary Medis: the cardiovascular generic Benazepril Hydrochlorothiazide tablets. With a launch quantity of approximately 10 million tablets, ...
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IVAX Corporation announced today that IVAX has signed an agreement with Mayne Pharma under which IVAX will exclusively distribute a number of Mayne’s generic injectable oncology products for certain markets in Central and Eastern Europe. Mayne Pharma will manufacture the products and receive payments from IVAX based on product sales....
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Jubilant Organosys Ltd, a composite pharmaceuticals industry player, has announced the acquisition of Trinity Laboratories, Inc. (Trinity) along with its wholly owned subsidiary Trigen Laboratories, Inc. (Trigen), a US-based generic pharmaceuticals company. ...
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Aurobindo Pharma Limited is delighted to share that the Company has received final approval from the US FDA for Stavudine tablets, 30 mg and 40 mg. This is once again, a first generic approval received by Aurobindo Pharma. ...
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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 generic version of DDAVP(R) (Desmopressin Acetate) Tablets, ...
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Ranbaxy Laboratories Limited (Ranbaxy), India, has entered into an in-licensing agreement with J. B. Chemicals & Pharmaceuticals Limited (JBCPL), India. As per the arrangement, Ranbaxy will market JBCPL’s key herbal range brand, ...
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Teva Pharmaceutical Industries Ltd. announced today that it has received a letter from the U.S. Food and Drug Administration (FDA) concerning the 180-day exclusivity period applicable to ANDAs for generic Pravastatin Sodium Tablets...
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Actavis Group has introduced a new cardiovascular generic product to the Dutch, British and Swedish markets upon patent expiry; Fosinopril tablets, in two strengths. The launch quantity is approximately 13 million tablets and the product is an important contributor to Actavis’ strong cardiovascular product line....
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Mylan Laboratories Inc. today announced that the U.S. Food and Drug Administration has granted approval for Mylan Pharmaceuticals Inc.'s Abbreviated New Drug Application for Mercaptopurine Tablets USP, 50 mg. Mercaptopurine Tablets, ...
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Today, the specialty pharmaceutical manufacturer Fougera released FDA approved Clotrimazole & Betamethasone Dipropionate Lotion USP 1%/0.05% (Rx). This combination product is AB rated to Lotrisoneâ by Scheringâ ...
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Ranbaxy Laboratories Limited (RLL) announced today that it has received tentative approval from the U.S. Food and Drug Administration (USFDA) to manufacture and market Zidovudine Tablets 300 mg....
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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 generic version of Aventis Pharmaceuticals' Allegra(R) (Fexofenadine Hydrochloride) ...
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IVAX Corporation received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for hydrochlorothiazide capsules 12.5 mg. This product will be sold through IVAX’ wholly owned subsidiary, IVAX Pharmaceuticals, ...
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British drug maker Shire Pharmaceuticals Group on Monday said that a patent infringement lawsuit it filed against Nostrum Pharmaceuticals, a New Jersey-based drug company, will go to trial after a U.S. federal court judge...
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Mylan Laboratories Inc. today reported that the U.S. District Court for the District of New Jersey issued an opinion today which concluded that the relevant patent may be properly construed to expressly claim topiramate. The final pretrial conference in this litigation is scheduled for September 19, with trial to be scheduled thereafter. ...
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The Perrigo Company today announced that it has received approval from the U.S. Food and Drug Administration (FDA) to manufacture and market prescription Ibuprofen Tablets, USP 400 mg, 600 mg and 800 mg. The product is equivalent to McNeil Consumer & Specialty Pharmaceuticals’ Motrin® tablets, 400 mg, 600 mg and 800 mg, indicated for the relief of the symptoms of arthritis, and relief of mild to moderate pain....
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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 ANDA for Tramadol and Acetaminophen Tablets, 37.5 mg/325 mg. Final approval is expected upon resolution of patent litigation....
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Shire Pharmaceuticals Group plc announced on June 7, 2005 that it had received a second Paragraph IV notice letter from Teva Pharmaceuticals USA, Inc. (Teva) advising of an amendment to Teva's existing ANDA for generic versions of ADDERALL XR®. ...
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Merck Sharp & Dohme (MSD) SA (a subsidiary of Merck & Co., Inc.,) has granted a non-exclusive, royalty–free patent license for the manufacture and supply of a generic version of efavirenz, (one of MSD’s antiretrovirals (ARV’s), used for the treatment of HIV/AIDS, ...
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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 ANDA for Fexofenadine Hydrochloride Tablets, 30 mg, 60 mg and 180 mg. ...
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Ranbaxy Laboratories Limited announced today that the Company has received tentative approval from the U.S. Food and Drug Administration to manufacture and market Glimepiride Tablets, 1 mg, 2 mg, 4 mg, and 8 mg. Total annual market sales for Glimepiride were $336.6 million...
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Spectrum has filed its eleventh ANDA (Abbreviated New Drug Application), with the U.S. Food and Drug Administration (FDA).
Spectrum Pharmaceuticals currently has eight other ANDAs that are under review at the FDA, including an ANDA with Paragraph IV certification for sumatriptan succinate injection, the generic form of GlaxoSmithKline's Imitrex(R) injection....
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Novartis announced today that it has completed the acquisition of approximately 98% of US-based generic pharmaceutical company Eon Labs, Inc. Following the acquisition last month of Hexal AG of Germany, the Sandoz generics division of Novartis now has a strong foothold and a leading position in the highly competitive generic drug industry.
With the combined strengths of the three companies ...
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Lupin Ltd announced that it has launched Ceftriaxone vials for injection in the US market. Ceftriaxone is the generic equivalent of Rocephin® marketed by Roche. As per MAT May 2005 IMS data, the U.S. market size for Ceftriaxone was at $ 756 million. ...
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Able Laboratories, Inc. today announced that it received notice from The Nasdaq Stock Market, Listing Qualifications Department that the staff had determined that the company's securities should be delisted from The Nasdaq Stock Market. ...
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Mistral Pharma Inc. announced today that its first generic product entered pilot clinical trials this week. If these trials are successful, the product will enter the Pivotal Clinical trials, the last important step before submitting the product for FDA approval....
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Lupin Ltd announced that it has launched Ceftriaxone vials for injection in the US market. Ceftriaxone is the generic equivalent of Rocephin® marketed by Roche. As per MAT May 2005 IMS data, the U.S. market size for Ceftriaxone was at $ 756 million. ...
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Prasco Laboratories, a privately-held pharmaceutical company located in Cincinnati, Ohio, announced today it has entered into a distribution and supply agreement with Aventis Pharmaceuticals Inc. (a member of the sanofi-aventis Group) for leflunomide tablets....
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TEVA Pharmaceutical Industries Ltd. and IVAX Corporation jointly announced today that they have signed a definitive agreement providing for the acquisition of IVAX by TEVA. Under the terms of the agreement, shares of IVAX common stock will, at the election of the shareholder, ...
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Nostrum Pharmaceuticals, Inc., a privately-held specialty pharmaceutical company engaged in the development and commercialization of generic drugs (ANDAs) and improved formulations of previously approved drugs based upon proprietary drug delivery technologies (505(b)(2) applications), ...
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Glenmark Pharmaceuticals Inc., U.S.A. [GPI], a wholly owned subsidiary of Glenmark Pharmaceuticals Ltd. [Glenmark], has commenced shipment of its generic equivalent Fosinopril Sodium oral tablets [Monopril®] for the U.S. market. ...
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Mayne Pharma (USA) Inc. today announced that on June 10, they received approval for their labels, cartons and package inserts to reflect multi dose labeling on their Carboplatin 50mg/5mL, 150mg/15mL, 450mg/45mL and 600mg/60mL solution presentations.
Mayne has the first and only generic Carboplatin 600mg/60mL multi dose solution presentation....
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Par Pharmaceutical Companies, Inc. today announced that the U.S. District Court for the District of New Jersey has issued a summary judgment ruling that GlaxoSmithKline's U.S. Patent Nos. 5,578,628 (the '628 patent) and 4,753,789 ...
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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 Glimepiride Tablets, 3 mg and 6 mg....
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IVAX Corporation announced today that its U.S. generic subsidiary, IVAX Pharmaceuticals, Inc. will distribute, in the United States, morphine sulfate controlled-release tablets C-II in 15, 30, 60, 100 and 200 mg dosage strengths supplied by Purdue Pharma LP of Stamford, ...
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