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.

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

Call for a Senate Inquiry into the pharmacy industry in Australia

With the current Pharmacy Agreement expiring on 30 June 2005 and the current Senate configuration in place until the same date, Dr Glasson said the timing is perfect for a comprehensive review of the protected environment in which the pharmacies operate.

26 Oct 2004

Cost cutting measures and patent expirations to propel the European generics and biogenerics market

The upcoming spate of patent expirations bodes well for the European generics market. The growing loss of patent protection on blockbuster brands over the next few years, coupled with the rising need to contain spiralling healthcare costs, is set to provide a fillip to market expansion.

19 Oct 2004

Teva Pharmaceutical granted FDA approval for Flumazenil injection

Teva Pharmaceutical Industries Ltd. has announced that the U.S. Food and Drug Administration has granted final approval for the Company’s ANDA for Flumazenil Injection, 0.1 mg/mL. Commercial marketing of this product will begin immediately.

13 Oct 2004

Flu vaccine shortage highlights need to accelerate the approval of affordable generic biopharmaceuticals and vaccines

Following the announcement that the nation is facing a flu vaccine shortage this year, the Generic Pharmaceutical Association (GPhA) renewed its call for the Food and Drug Administration (FDA) and Congress to move forward to accelerate the approval of affordable generic biopharmaceuticals and vaccines.

8 Oct 2004

One group of drugs that is effective in fighting HIV may also be promoting the death of sensory nerves in the skin

One group of drugs that is effective in fighting HIV may, paradoxically, also be promoting the death of sensory nerves in the skin, according to a study presented October 5, 2004, at the 129th annual meeting of the American Neurological Association in Toronto.

5 Oct 2004

Generic Drug News and Research

Further Reading

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

Call for a Senate Inquiry into the pharmacy industry in Australia

Cost cutting measures and patent expirations to propel the European generics and biogenerics market

Teva Pharmaceutical granted FDA approval for Flumazenil injection

Flu vaccine shortage highlights need to accelerate the approval of affordable generic biopharmaceuticals and vaccines

One group of drugs that is effective in fighting HIV may also be promoting the death of sensory nerves in the skin

A New Approach to Preventing Bladder Cancer Recurrence

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