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.

Court grants AstraZeneca temporary restraining order against Apotex in PULMICORT RESPULES patent litigation

On 16 April 2009, the US District Court for the District of New Jersey granted AstraZeneca's request for a temporary restraining order, barring Apotex (Apotex, Inc. and Apotex Corp.) from launching a generic version of AstraZeneca's PULMICORT RESPULES until further order of the court.

16 Apr 2009

Valproate exposure during pregnancy can impair a child's cognitive development

Three-year-olds whose mothers took the antiepileptic drug valproate during pregnancy had average IQs six to nine points lower than children exposed to three other antiepileptic drugs, a landmark multi-center study has found.

15 Apr 2009

FDA grants Oasmia's Paclical orphan drug designation for ovarian cancer in U.S.

Oasmia Pharmaceutical, Uppsala, Sweden, has been granted Orphan Drug designation by the USA FDA of Paclical for the treatment of ovarian cancer.

14 Apr 2009

Mylan confirms first-to-file patent challenge relating to Xeloda

Mylan Inc. has confirmed that the company and its subsidiary Mylan Pharmaceuticals Inc. have been sued by Hoffmann-La Roche Inc. in connection with the filing of an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) for Capecitabine Tablets, 150 mg and 500 mg, the generic version of Xeloda Tablets, a chemotherapy treatment for breast and colorectal cancer.

14 Apr 2009

Mylan settles Clarinex patent case

Mylan Inc. has announced the settlement of all patent litigation relating to Desloratadine Tablets, 5 mg, the generic version of Schering- Plough's Clarinex allergy medication.

9 Apr 2009

Cost-cutting measures are creeping into the medicine cabinet

Cost-cutting measures are creeping into the medicine cabinet. We split pills in half or take the drugs every other day to stretch our doses. We stop filling the prescriptions for our most expensive drugs. We buy prescriptions from online pharmacies with questionable credentials.

6 Apr 2009

Gilead Sciences announces notification of ANDA filing for Atripla

Gilead Sciences, Inc. has announced receipt of a Paragraph IV Certification Notice Letter advising that Teva Pharmaceuticals submitted an Abbreviated New Drug Application (ANDA) to the U.S. Food and Drug Administration (FDA) requesting permission to manufacture and market a generic version of Atripla (efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg). Atripla is currently sold in the United States through a joint venture between Bristol-Myers Squibb and Gilead.

6 Apr 2009

Taro receives final FDA approval for Carbamazepine extended-release tablets

Taro Pharmaceutical Industries Ltd. has reported that it received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application ("ANDA") for Carbamazepine Extended-Release Tablets USP, 100 mg, 200 mg and 400 mg ("carbamazepine extended-release tablets").

6 Apr 2009

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

Generic Drug News and Research

Further Reading

Court grants AstraZeneca temporary restraining order against Apotex in PULMICORT RESPULES patent litigation

Valproate exposure during pregnancy can impair a child's cognitive development

FDA grants Oasmia's Paclical orphan drug designation for ovarian cancer in U.S.

Mylan confirms first-to-file patent challenge relating to Xeloda

Mylan settles Clarinex patent case

Cost-cutting measures are creeping into the medicine cabinet

Gilead Sciences announces notification of ANDA filing for Atripla

Taro receives final FDA approval for Carbamazepine extended-release tablets

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

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