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.

Barr confirms patent challenge of Prevacid SoluTab tablets

Barr Pharmaceuticals, Inc. has confirmed that its subsidiary, Barr Laboratories, Inc., has initiated a challenge of the patents listed by TAP Pharmaceuticals Inc. in connection with its Prevacid SoluTab Delayed-Release Orally Disintegrating Tablets (lansoprazole), 15mg and 30mg.

11 Jun 2008

Obama launches economic tour, promotes health care proposal

Presumptive Democratic presidential nominee Sen. Barack Obama (Ill.) on Monday began a two-week economic tour in Raleigh, N.C., where he discussed his proposals to address the economy, health care and other issues, the AP/Philadelphia Daily News reports (Babington, AP/Philadelphia Daily News, 6/10).

11 Jun 2008

Mylan announces final FDA approval for Zaleplon capsules, generic version of Sonata

Mylan Inc. has announced that its subsidiary, Genpharm ULC, has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Zaleplon Capsules, 5 mg and 10 mg.

9 Jun 2008

Walgreen agrees to pay $35 million to settle allegations of improper medication switches for Medicaid beneficiaries

Walgreen has agreed to pay $35 million to settle allegations that the company improperly switched the form of generic medications prescribed to Medicaid beneficiaries to receive higher reimbursements from the program, the Hartford Courant reports (Levick, Hartford Courant, 6/5).

8 Jun 2008

FDA grants pediatric exclusivity for UCB's Keppra

UCB has announced that the US Food and Drug Administration (FDA) has granted pediatric exclusivity for Keppra (levetiracetam). The decision was based on pediatric data submitted to the FDA following a written request in 2001.

8 Jun 2008

Survey shows Americans regard reducing the cost of prescription drugs as highest health care priority

In a national survey released today by the Alliance of Minority Medical Associations (AMMA), Americans noted that their highest health care priority is reducing the cost of prescription drugs. Furthermore, survey respondents shared overwhelming support for creating an approval pathway for generic, or follow-on biotechnology therapies, with 86% of likely voters stating their desire for such a system.

4 Jun 2008

Mylan confirms Azor patent challenge

Mylan Inc. today confirmed that its majority-owned subsidiary, Matrix Laboratories Ltd., has been sued by Daiichi Sankyo in connection with Amlodipine Besylate/Olmesartan Medoxomil Tablets, 5 mg/20 mg, 10 mg/20 mg, 5 mg/40 mg and 10 mg/40 mg, the generic version of Daiichi Sankyo's Azor Tablets.

4 Jun 2008

Cephalon files patent infringement case against Watson Pharmaceuticals

Cephalon, Inc. today announced that it and its wholly-owned subsidiary CIMA LABS INC. have filed a lawsuit in U.S. District Court in Delaware against Watson Pharmaceuticals, Inc. and its wholly-owned subsidiary, Watson Laboratories, Inc., for infringement of U.S. Patent Nos. 6,200,604 and 6,974,590, which cover methods of use for the Cephalon product FENTORA(R) (fentanyl buccal tablet) [C-II].

3 Jun 2008

Mylan acquires generics businesses of Merck KGaA

Mylan Inc. today announced that it has acquired Merck KGaA's Central & Eastern Europe (CEE) generics businesses, which include operations in Poland, Hungary, Slovakia, Slovenia and the Czech Republic.

2 Jun 2008

Watson receives approval of Omeprazole delayed-release capsules

Watson Pharmaceuticals, Inc. has announced today that it has received final approval from the U.S. Food and Drug Administration ("FDA") of its Abbreviated New Drug Application (ANDA) for Omeprazole Delayed-Release Capsules USP in the 10mg, 20mg and 40mg strengths.

2 Jun 2008

Brand-name prescription drug companies reached 14 deals with generic manufacturers to delay sale of generics in FY 2007

Brand-name prescription drug makers in fiscal year 2007 reached 14 agreements with generic drug makers to delay market entry of generic medications, according to a report released on Wednesday by the Federal Trade Commission, Reuters reports (Bartz, Reuters, 5/23).

28 May 2008

Express Scripts reaches $9.5 million settlement with 28 states over allegations of misleading consumers to obtain rebates

Officials from pharmacy benefit manager Express Scripts on Tuesday said the company has agreed to pay $9.5 million to settle lawsuits brought by 28 states and Washington, D.C., alleging it defrauded the states and D.C., the AP/Denver Post reports.

28 May 2008

Barr confirms Entocort patent challenge

Barr Pharmaceuticals, Inc. today confirmed that its subsidiary, Barr Laboratories, Inc., has initiated a challenge of the patents listed by AstraZeneca LP in connection with its Entocort(R) Enteric Coated Capsules (budesonide), 3mg.

27 May 2008

Breakthrough by WHO will give poor countries better access to drugs

An agreement has been reached by world health leaders regarding approaches to drug research and development and improving access to medicines.

27 May 2008

Report cites 15 New York State HMOs for setting consumer restrictions on prescription drugs to boost profits

Some HMOs in New York state are restricting patients' access to so-called single-source drugs, brand-name medications for specific ailments that do not have lower-cost generic versions, according to a report released on Sunday, the New York Daily News reports.

20 May 2008

Industry group letter indicates qualified aupport for bill to allow approval of generic biotechnology medications

The Biotechnology Industry Organization has issued a letter to Reps. Anna Eshoo (D-Calif.) and Joe Barton (R-Texas) to indicate qualified support for a bill (HR 5629) that they have introduced to allow FDA to approve generic biotech medications, CQ HealthBeat reports (McCarthy, CQ HealthBeat, 5/16).

19 May 2008

National Community Pharmacists Association to launch ad campaign to lobby lawmakers for policy changes

The National Community Pharmacists Association this week plans to launch a new advertising campaign that asks lawmakers to address two policies that the group maintains has or will result in closures of community pharmacies, CongressDaily reports. As part of the launch of the campaign, about 500 community pharmacists and independent pharmacy owners will visit Washington, D.C.

19 May 2008

Taiwan approves WTO amendment allowing countries to export lower-cost versions of antiretrovirals, other drugs to developing countries

Taiwan's legislative body the Yuan on Thursday approved the first reading of a proposed World Trade Organization amendment that would allow pharmaceutical companies to make lower-cost versions of generic antiretroviral drugs, as well as drugs for malaria and other diseases, to sell to developing countries, the CNA/Taipei Times reports.

19 May 2008

American Medical Association officials outline provisions physicians would accept in electronic prescribing legislation

The American Medical Association on Friday discussed a set of standards that physicians would accept for any electronic prescribing requirement under Medicare, CongressDaily reports.

13 May 2008

Canadian drug company awarded Rwandan contract to provide combination antiretroviral

Rwanda recently accepted a bid from the Toronto-based generic drug company Apotex to supply its fixed-dose combination antiretroviral drug Apo-triAvir to the country, the Toronto Star reports (Toronto Star, 5/9).

13 May 2008

Generic Drug News and Research

Further Reading

Barr confirms patent challenge of Prevacid SoluTab tablets

Obama launches economic tour, promotes health care proposal

Mylan announces final FDA approval for Zaleplon capsules, generic version of Sonata

Walgreen agrees to pay $35 million to settle allegations of improper medication switches for Medicaid beneficiaries

FDA grants pediatric exclusivity for UCB's Keppra

Survey shows Americans regard reducing the cost of prescription drugs as highest health care priority

Mylan confirms Azor patent challenge

Cephalon files patent infringement case against Watson Pharmaceuticals

Mylan acquires generics businesses of Merck KGaA

Watson receives approval of Omeprazole delayed-release capsules

Brand-name prescription drug companies reached 14 deals with generic manufacturers to delay sale of generics in FY 2007

Express Scripts reaches $9.5 million settlement with 28 states over allegations of misleading consumers to obtain rebates

Barr confirms Entocort patent challenge

Breakthrough by WHO will give poor countries better access to drugs

Report cites 15 New York State HMOs for setting consumer restrictions on prescription drugs to boost profits

Industry group letter indicates qualified aupport for bill to allow approval of generic biotechnology medications

National Community Pharmacists Association to launch ad campaign to lobby lawmakers for policy changes

Taiwan approves WTO amendment allowing countries to export lower-cost versions of antiretrovirals, other drugs to developing countries

American Medical Association officials outline provisions physicians would accept in electronic prescribing legislation

Canadian drug company awarded Rwandan contract to provide combination antiretroviral

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