Generic Drug News and Research

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Generic Drugs are official nonbrand names by which medicines are known. Generic names usually refer to the chemical name of the drug.

Canadian Senator proposes process to expedite export of low-cost drugs for HIV, other diseases

Canadian Sen. Yoine Goldstein earlier this week proposed a bill that would reform Canada's Access to Medicines Regime by expediting the process of exporting generic drugs for diseases such as HIV to developing countries, the Ottawa Citizen reports.

5 Apr 2009

Opioid antagonists show potential for problematic pain

Achieving effective, durable, and safe pain relief, especially in patients with chronic and/or severe pain conditions, can be difficult.

2 Apr 2009

Teva receives approval for generic Yaz (Drospirenone and Ethinyl Estradiol) tablets

Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that the U.S. Food and Drug Administration has granted approval for the Company's Abbreviated New Drug Application (ANDA) to market its generic version for Bayer Healthcare Pharmaceuticals' oral contraceptive Yaz® (Drospirenone and Ethinyl Estradiol) Tablets.

1 Apr 2009

FDA approves generic Topamax tablets (topiramate)

The U.S. Food and Drug Administration has approved the first generic versions of Topamax tablets (topiramate) to prevent seizures.

1 Apr 2009

District Court decision received in Concerta patent sase

The U.S. District Court for the District of Delaware has rendered a decision in the patent litigation between Alza Corporation, McNeil-PPC, Inc. and Andrx Pharmaceuticals LLC. McNeil Pediatrics, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc., which markets Concerta (methylphenidate HCI) Extended-Release Tablets CII, said the court held that the patent in suit is not valid or infringed by the filing of Andrx's Abbreviated New Drug Application.

1 Apr 2009

House subcommittee to conduct hearing to discuss strategies to end agreements between brand-name, generic drugmakers, limit number of plans

A House Energy and Commerce subcommittee on Tuesday is scheduled to conduct a hearing on the issue of ending agreements under which brand-name pharmaceutical companies pay generic drugmakers to delay the launch of less costly versions of top-selling medications, the Wall Street Journal reports.

31 Mar 2009

CMS announces new rules for Medicare Advantage plans that aim to protect sick beneficiaries from high out-of-pocket costs

CMS on Monday announced that insurers looking to offer Medicare Advantage plans this year must cap out-of-pocket charges and that the agency will eliminate MA plans that have 10 or fewer beneficiaries, the Wall Street Journal reports.

31 Mar 2009

Mylan's Matrix receives tentative FDA approval under PEPFAR for generic Truvada

Mylan Inc. has announced that Matrix Laboratories Limited, its India-based subsidiary in which it holds a 71.2% controlling interest, has received the first tentative approval from the U.S. Food and Drug Administration (FDA) under the President's Emergency Plan for AIDS Relief (PEPFAR) for its Abbreviated New Drug Application (ANDA) for Emtricitabine and Tenofovir Disoproxil Fumarate Tablets, 200 mg/300 mg.

30 Mar 2009

BioMarin receives notice of allowance for Kuvan patent

BioMarin Pharmaceutical Inc. has announced that it has received a notice from the United States Patent Office reporting allowance of claims covering once daily dosing methods for Kuvan (sapropterin dihydrochloride) in the treatment of phenylketonuria (PKU).

30 Mar 2009

Wal-Mart in talks with several companies to expand prescription drug discount program for employees

Wal-Mart on Friday announced that it is in negotiations to expand to several other companies a generic drug purchasing pilot program it currently runs with Caterpillar, the Chicago Tribune reports.

30 Mar 2009

Senate measure would allow generic versions of biotechnology drugs after five years

Sens. Charles Schumer (D-N.Y.) and Susan Collins (R-Maine) on Thursday introduced legislation (S 726) that would allow FDA to approve generic versions of biotechnology drugs after a five-year period of brand-name patent exclusivity, the New York Times reports.

30 Mar 2009

Mylan confirms four first-to-file challenges

Mylan Inc. has announced that it and/or a subsidiary have been sued in connection with four separate "first-to-file" Abbreviated New Drug Applications (ANDA) filed with the U.S. Food and Drug Administration (FDA).

29 Mar 2009

Sagent Pharmaceuticals receives FDA approval of Azithromycin for injection

Sagent Pharmaceuticals, Inc. has announced U.S. Food and Drug Administration (FDA) approval of azithromycin for injection, a semi-synthetic, macrolide antibiotic that is used to treat a wide variety of bacterial infections. Sagent will offer azithromycin in a 500 mg vial for intravenous use.

26 Mar 2009

New York State to offer low-income, disabled residents prescription drug discount cards

New York state officials on Monday announced a statewide prescription drug discount card program for residents with disabilities, people who are too young to qualify for Medicare and those whose incomes are too high to qualify for Medicaid, the Rochester Democrat and Chronicle reports.

25 Mar 2009

Drop in Walgreen profits reflects change in consumer prescription needs

Rising unemployment and other economic problems have led some consumers to delay filling prescriptions or cut pills in half, according to Walgreen executives, the Wall Street Journal reports.

24 Mar 2009

Cubist Pharmaceuticals files patent infringement case against Teva Parenteral Medicines

Cubist Pharmaceuticals, Inc. has confirmed that it has filed a patent infringement lawsuit against Teva Parenteral Medicines, Inc. (TPM), Teva Pharmaceuticals USA, Inc. and Teva Pharmaceutical Industries Ltd.

23 Mar 2009

New theory on tumor growth and metastasis based on differences in tissue pressure

The HFSP Journal, the interdisciplinary journal for scientists conducting high quality, innovative research at the interface between biology and the physical sciences is pleased to announce that the latest article modelling of tumor growth and metastasis in now available online.

23 Mar 2009

CQ's Armstrong discusses proposed public health plan option; new bill on FDA tobacco regulation

Drew Armstrong, a Congressional Quarterly staff reporter, discusses the latest developments in efforts to overhaul the U.S. health care system, legislation that would give FDA regulatory authority over tobacco products and a new bill that would allow FDA to approve generic versions of biotechnology drugs in this week's "Health on the Hill from kaisernetwork.org and CQ."

23 Mar 2009

Warner Chilcott files new lawsuit for infringement of DORYX patent

Warner Chilcott Limited has announced hat one of its subsidiaries and Mayne Pharma International Pty. Ltd. ("Mayne") have filed a second lawsuit against Impax Laboratories, Inc. ("Impax") in the District Court for the District of New Jersey for infringement of Mayne's U.S. Patent No. 6,958,161 (the "'161 Patent") which covers DORYX, a tetracycline-class oral antibiotic.

20 Mar 2009

Eli Lilly granted temporary restraining order to halt launch of generic Raloxifene

Eli Lilly and Company has issued the following statement after being granted a temporary restraining order to halt the launch of a generic version of Evista (raloxifene HCl tablets) by Teva Pharmaceuticals.

11 Mar 2009

Generic Drug News and Research

Further Reading

Canadian Senator proposes process to expedite export of low-cost drugs for HIV, other diseases

Opioid antagonists show potential for problematic pain

Teva receives approval for generic Yaz (Drospirenone and Ethinyl Estradiol) tablets

FDA approves generic Topamax tablets (topiramate)

District Court decision received in Concerta patent sase

House subcommittee to conduct hearing to discuss strategies to end agreements between brand-name, generic drugmakers, limit number of plans

CMS announces new rules for Medicare Advantage plans that aim to protect sick beneficiaries from high out-of-pocket costs

Mylan's Matrix receives tentative FDA approval under PEPFAR for generic Truvada

BioMarin receives notice of allowance for Kuvan patent

Wal-Mart in talks with several companies to expand prescription drug discount program for employees

Senate measure would allow generic versions of biotechnology drugs after five years

Mylan confirms four first-to-file challenges

Sagent Pharmaceuticals receives FDA approval of Azithromycin for injection

New York State to offer low-income, disabled residents prescription drug discount cards

Drop in Walgreen profits reflects change in consumer prescription needs

Cubist Pharmaceuticals files patent infringement case against Teva Parenteral Medicines

New theory on tumor growth and metastasis based on differences in tissue pressure

CQ's Armstrong discusses proposed public health plan option; new bill on FDA tobacco regulation

Warner Chilcott files new lawsuit for infringement of DORYX patent

Eli Lilly granted temporary restraining order to halt launch of generic Raloxifene

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