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.

Government should plough drug savings into Pharmaceutical Benefits Scheme (PBS)

Doctors and medicine-makers today called for an expected $280 million Pharmaceutical Benefits Scheme (PBS) windfall to be ploughed into bringing down the price of new cancer and HIV drugs.

9 Jan 2005

Polycystic ovary syndrome (PCOS), the most common endocrine disorder among reproductive-age women

The polycystic ovary syndrome (PCOS), the most common endocrine disorder among reproductive-age women, produces a wide variety of body changes with both physical and emotional implications for sufferers.

3 Jan 2005

Public health advisory for the use of non-steroidal anti-inflammatory drug products

The Food and Drug Administration (FDA) has issued a Public Health Advisory summarizing the agency's recent recommendations concerning the use of non-steroidal anti-inflammatory drug products (NSAIDs), including those known as COX-2 selective agents.

23 Dec 2004

The burgeoning Indian AIDS epidemic

India, home to one-sixth of the human race, has an AIDS epidemic. Five million Indians are living with HIV infection. The stakes are high; the government is racing against time.

21 Dec 2004

Tentative approval for Topiramate Tablets

Ranbaxy Pharmaceuticals announced tentative approval from the U.S. Food and Drug Administration to manufacture and market Topiramate Tablets, 25 mg, 100 mg, and 200 mg. Total annual market sales for Topiramate were $1,184 million with sales of these three strengths of tablets totaling $1,129 million.

20 Dec 2004

Early ritalin may cause long-term effects on the brain

A new study conducted in rats by the National Institutes of Health (NIH) and McLean Hospital/Harvard Medical School suggests that the misdiagnosis of attention-deficit hyperactivity disorder (ADHD) combined with prescription drug use in children may lead to a higher risk of developing depressive symptoms in adulthood.

13 Dec 2004

World Health Organization is reinstating two antiretrovirals manufactured by Cipla Ltd

The two medicines (which are used in the treatment of AIDS) had been delisted by WHO in May this year due to non-compliance with international standards at the contract research organizations (CROs) hired by Cipla to conduct bioequivalence tests on the products.

30 Nov 2004

Guatemalan Congress repeals law that restricted access to medicines

The Guatemalan Congress's repeal of a law that severely restricts people's access to affordable essential medicines is a positive step forward.

29 Nov 2004

Manufacturers in the European active pharmaceutical ingredients market are struggling to overcome a variety of challenges

Manufacturers in the crowded and highly fragmented European active pharmaceutical ingredients (API) market are struggling to overcome a variety of challenges. One of the most pressing of these is the problem of overcapacity.

29 Nov 2004

Hetero Drugs withdraws antiretrovirals

Following an inspection by the World Health Organization (WHO), generic manufacturer Hetero Drugs Limited, in Hyderbad, India, is withdrawing six antiretrovirals from the WHO prequalification list in order to review data on their bioequivalence.

20 Nov 2004

FDA Vioxx fiasco raises questions about AIDS drug approvals for developing world

AIDS Healthcare Foundation (AHF), today noted that the current "FDA fiasco" involving the agency's initial approval and subsequent recall of Merck's troubled arthritis drug, Vioxx, raises serious questions about the FDA's ongoing parallel role in the approval of generic AIDS drugs for widespread use in Africa and the developing world.

19 Nov 2004

Generic antipsychotic drugs can protect brain cells from progressive multifocal leukoencephalopathy

Generic antipsychotic drugs can protect brain cells from a virus that causes a fatal nervous system disorder, according to research conducted at Brown University and Case Western Reserve University.

18 Nov 2004

Eisai In-licenses Anti-hepatitis B Agent clevudine From Bukwang Pharm

Eisai Co., Ltd. announced today that the Company has in-licensed an anti-hepatitis B agent (generic name: clevudine) from Bukwang Pharm (Headquarters, Seoul, South Korea, President: Sung-Koo Lee).

16 Nov 2004

Use of the drug etodolac instead of drugs like Celebrex or Bextra could save $40 million annually

People in search of pain relief who take the generic anti-inflammatory etodolac suffer 60 percent fewer gastrointestinal complications than those who take similar drugs, according to researchers at UT Southwestern Medical Center at Dallas and the Dallas Veterans Affairs Medical Center.

14 Nov 2004

Morton Grove Pharmaceuticals increases production of antiviral flu drug, Amantadine

During the current flu vaccine shortage, the Centers for Disease Control and Prevention, Department of Health and Human Services, has issued guidance recommending the use of certain alternative antiviral medications.

8 Nov 2004

Generic statin drugs shown to produce similar or better results than expensive brand-name drugs

Researchers from Kaiser Permanente's Northern California region are presenting a study at this week's American Heart Association Scientific Sessions showing that patients who use a generic statin drug rather than its brand-name equivalent fared as well as- sometimes better than-patients on the more expensive drug.

8 Nov 2004

Generic drugs are still a good buy

A new AARP study found that manufacturers' prices for some generic drugs experienced a rapid rise over the past three years. However, these increases would have added only a few dollars per year to consumers' costs for any one of these products.

4 Nov 2004

Guidance for generic drugs

The U.S. Food and Drug Administration (FDA) has announced that a Guidance for Industry entitled "Listed Drugs, 30-Month Stays, and Approval of ANDAs and 505(b)(2) Applications Under Hatch-Waxman, as Amended by the Medicare Prescription Drug, Improvement, and Modernization Act of 2003

4 Nov 2004

Patent litigation the most commonly used generic defense strategy among pharmaceutical companies

Patent litigation remains the most commonly used generic defense strategy among pharmaceutical companies. 71% of drug companies have used legal battles to defend their patents in the past three years, according to research from pharmaceutical business intelligence firm Cutting Edge Information.

4 Nov 2004

Urinary incontinence is passed down from mother to daughter

New research from the University of Bergen (UiB), Norway, shows that a woman who’s mother has urinary incontinence has a 30 percent greater chance for incontinence herself.

4 Nov 2004

Generic Drug News and Research

Further Reading

Government should plough drug savings into Pharmaceutical Benefits Scheme (PBS)

Polycystic ovary syndrome (PCOS), the most common endocrine disorder among reproductive-age women

Public health advisory for the use of non-steroidal anti-inflammatory drug products

The burgeoning Indian AIDS epidemic

Tentative approval for Topiramate Tablets

Early ritalin may cause long-term effects on the brain

World Health Organization is reinstating two antiretrovirals manufactured by Cipla Ltd

Guatemalan Congress repeals law that restricted access to medicines

Manufacturers in the European active pharmaceutical ingredients market are struggling to overcome a variety of challenges

Hetero Drugs withdraws antiretrovirals

FDA Vioxx fiasco raises questions about AIDS drug approvals for developing world

Generic antipsychotic drugs can protect brain cells from progressive multifocal leukoencephalopathy

Eisai In-licenses Anti-hepatitis B Agent clevudine From Bukwang Pharm

Use of the drug etodolac instead of drugs like Celebrex or Bextra could save $40 million annually

Morton Grove Pharmaceuticals increases production of antiviral flu drug, Amantadine

Generic statin drugs shown to produce similar or better results than expensive brand-name drugs

Generic drugs are still a good buy

Guidance for generic drugs

Patent litigation the most commonly used generic defense strategy among pharmaceutical companies

Urinary incontinence is passed down from mother to daughter

Achieving and maintaining ISO/IEC 27001 and BS 10012 certifications

Expanding research and clinical options for children with cancer

Examining how pain could play a direct protective role in the gut

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