Generics News Archives for Drug Development

February 2005 News Archive

01/02/2005

Two Approvals From USFDA In A Row For Zydus Cadila - After Atenolol, its Clindamycin

Close on heels of getting its first product approval, Zydus Cadila has now received approval to market Clindamycin, an anti-infective drug in the US market. The total US market for this drug is estimated at US $87 mn as per 2003 IMS data. ...

02/02/2005

IMPAX Receives Tentative FDA Approval for Generic Version of Ditropan XL; First Approval in 2005

HAYWARD, Calif., Feb 2, 2005 (BUSINESS WIRE) -- IMPAX Laboratories, Inc. (NASDAQ:IPXL) today announced that the U.S. Food and Drug Administration (FDA) has granted tentative approval to the Company's Abbreviated New Drug Application (ANDA) for a generic version of Ditropan(R) XL (Oxybutynin Chloride) 5, 10 and 15 mg Extended Release Tablets. ...

03/02/2005

Taro Receives Approval for Miconazole Nitrate Vaginal Cream, 4% ANDA

...

04/02/2005

Barr Sues FDA to Obtain Sole Exclusivity on Allegra-DR

Feb 04, 2005 /PRNewswire-FirstCall via COMTEX/ -- Barr Pharmaceuticals, Inc. (NYSE: BRL) today announced that its subsidiary, Barr Laboratories, Inc., has filed suit against the U.S. Food and Drug Administration (FDA) in the United States District Court for the District of Columbia....

04/02/2005

Mylan Receives FDA Approval for Citalopram Hydrobromide Tablets

Mylan Laboratories Inc. (NYSE: MYL) today announced that the U.S. Food and Drug Administration has granted final approval for Mylan Pharmaceuticals Inc.'s Abbreviated New Drug Application for Citalopram Hydrobromide Tablets, 10 mg, 20 mg and 40 mg. Citalopram Hydrobromide is the generic version of Forest Laboratories Inc.'s Celexa(R).

The product will be shipped immediately....

10/02/2005

Mylan Receives Tentative Approval for Modafinil Tablets

Mylan Laboratories Inc. (NYSE: MYL) today announced that the U.S. Food and Drug Administration has granted tentative approval for Mylan Pharmaceuticals Inc.'s Abbreviated New Drug Application for Modafinil Tablets, 100 mg and 200 mg....

11/02/2005

IVAX Corporation Announces Settlement of Litigation Against FDA and Alpharma

MIAMI - February 11, 2005 - IVAX Corporation (AMEX: IVX, LSE: IVX.L) today announced that it has entered into a settlement of its litigation with the United States Food and Drug Administration and Alpharma Inc. regarding gabapentin, the generic equivalent of NeurontinÂ®. ...

12/02/2005

Sildenafil Viagra patent claims restricted by Federal Court of Australia to exclude Tadalafil Cialis

On 10th February 2005 Honourable Justice Heerey of the Federal Court of Australia handed down a judgement on the long-running patent dispute between Pfizer and Eli Lilly relating to their respective male erectile dysfunction treatments ViagraTM and CialisTM....

17/02/2005

Teva Announces Settlement Of LamictalÂ® Litigation With Glaxosmithkline

Jerusalem, Israel, February 17, 2005 - Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that it has settled patent litigation with GlaxoSmithKline relating to lamotrigine, the generic version of GlaxoSmithKline's LamictalÂ®....

21/02/2005

Novartis To Acquire Hexal AG and Eon Labs, Creating the World Leader In Generics

Â· Transformational merger of Hexal and Eon Labs with Sandoz strengthens market positions globally, achieving top positions in key markets, particularly US and Germany

Â· Significantly broadened product portfolio ...

22/02/2005

Alpharma Launches Authorized Generic of MGI PHARMA's SalagenÂ® 5mg Tablets

Fort Lee, New Jerseyâ€¦February 22, 2005â€¦Alpharma Inc. today announced that, as a result of an agreement with MGI PHARMA, INC. in January 2005, the company launched pilocarpine 5mg tablets, the generic version of MGI PHARMA's product, SalagenÂ® 5mg Tablets....

22/02/2005

Mayne Pharma USA Inc. Adds Carboplatin 600mg/60mL Injection to its Product Line

PARAMUS, NJ, February 22, 2005. Mayne Pharma (USA) Inc. today announce dthe availability of the first generic version of the Carboplatin 600mg/60mL presentation. The US Food and Drug Administration (FDA) granted approval for the company's Abbreviated New Drug Application for Carboplatin 600mg/60ml solution on November 23rd, 2004....

24/02/2005

Teva Announces Approval Of Methylprednisolone Acetate Injectable Suspension

Jerusalem, Israel, February 24, 2005 - Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA) announced today that the U.S. Food and Drug Administration has granted final approval for the Company's ANDA for Methylprednisolone Acetate Injectable Suspension, 40 mg/mL and 80 mg/mL in single dose vials....

24/02/2005

PLIVA and Mayne Enter Biogeneric Partnership for EPO and G-CSF

PLIVA d.d. (PLIVA) announced today that its affiliates PAM Kft. and PLIVA CROATIA Ltd. Have entered into a strategic collaboration with Mayne Pharma (Mayne), a leading international hospital generics company, for the development, supply and marketing of PLIVA's two most advanced follow on biologics programs, erythropoietin (EPO) and granulocyte colony stimulating factor (G-CSF)....

24/02/2005

Alpharma Announces Development and Manufacturing Agreement with Orchid

Fort Lee, New Jerseyâ€¦February 24, 2005â€¦Alpharma Inc., announced today that it has entered into an agreement with Orchid Chemicals & Pharmaceuticals Ltd (Orchid), a Chennai-based global pharmaceutical company, whereby Orchid will develop, manufacture and supply generic prescription products for exclusive sale by Alpharma. ...

28/02/2005

Impax Files Motion to Intervene as Defendant in Litigation Related to Generic Allegra-D

HAYWARD, Calif., Feb 28, 2005 (BUSINESS WIRE) -- IMPAX Laboratories, Inc. (NASDAQ:IPXL) today announced that it has filed a motion in the United States District Court for the District of Columbia to intervene as a defendant in a lawsuit by Barr Laboratories, Inc. against the United States Food and Drug Administration (FDA). ...

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