News

On July 29, 2005, the FDA alerted US consumers that 20 mg Lipitor (atorvastatin) was recalled by UK health authorities. The Lipitor is sold in 28 tablet packages with batch number 004405K1 and an expiration date of November 2007. Counterfeit Lipitor was discovered in this particular batch. Since legitimate 20 mg Lipitor has the same batch number, UK health authorities are recalling the entire lot.

Ten months after FDA approval and six months after marketing commencement, the FDA has asked Purdue Pharma to withdraw Palladone (extended-release hydromorphone hydrochloride capsules) from the US market.

FDA Talk Paper - July 1, 2005

FDA Reviews Data for Antidepressant Use in Adults

In response to recent scientific publications that report the possibility of increased risk of suicidal behavior in adults treated with antidepressants, the U.S. Food and Drug Administration (FDA) has issued a Public Health Advisory (PHA) to update patients and healthcare providers with the latest information on this subject.

Even before the publication of these recent reports, FDA had already begun the process of reviewing available data to determine whether there is an increased risk of suicidal behavior in adults taking antidepressants. The Agency has asked manufacturers to provide information from their trials using an approach similar to that used in the evaluation of the risk of suicidal behavior in the pediatric population taking antidepressants. This effort will involve hundreds of clinical trials and may take more than a year to complete.

FDA Talk Paper - July 1, 2005

FDA Issues Nationwide Alert for "Liqiang 4" Due to Potential Health Risk

The U.S. Food and Drug Administration (FDA) is warning consumers not to take Liqiang 4 Dietary Supplement Capsules because they contain glyburide – a drug that could have serious, life-threatening consequences in some people.

FDA News - June 24, 2005

FDA Tentatively Approves Generic Efavirenz – Product Eligible To Be Considered Under the President’s Emergency Plan for AIDS Relief

The Food and Drug Administration (FDA) within the U.S. Department of Health and Human Services (HHS) today announced the tentative approval of efavirenz tablets manufactured by Aurobindo Pharma LTD. of Hyderabad, India. This product is the first tentatively approved generic version of Sustiva Tablets (manufactured by Bristol-Myers Squibb). Efavirnez will now be available for consideration for purchase under the President's Emergency Plan for AIDS Relief (PEPFAR).

FDA News - June 23, 2005

FDA Approves BiDil Heart Failure Drug for Black Patients

The Food and Drug Administration (FDA) approved BiDil (bye-DILL), a drug for the treatment of heart failure in self-identified black patients, representing a step toward the promise of personalized medicine.

Heart failure is a condition in which the heart is weakened and does not pump enough blood. It can be caused by a variety of damage to the heart, including heart attacks, high blood pressure, and infections.

FDA News - June 23, 2005

FDA Approves New Therapy for HIV Patients with Advanced Disease

The Food and Drug Administration (FDA) announced the approval of Aptivus (tipranavir) capsules, an HIV protease inhibitor, to be given with ritonavir for treatment of HIV-1 infected adults. This is the second drug approved for patients with advanced HIV disease, and provides a new therapy for patients with limited treatment options.

FDA News - May 27, 2005

FDA Advises Consumers about Recalled Drugs from Able Laboratories

The FDA published a list of all products made by Able Laboratories, including those drugs made by Able for other companies. The news report includes the imprint codes on tablets and capsules.

If you are taking any drugs made by Able, the FDA recommends that you talk to your doctor or pharmacist about obtaining a replacement product.

Able Laboratories Press Release - May 23, 2005

Able Laboratories, Inc. Suspends Manufacturing Operations, Announces Product Recall

-- To Withdraw Certain Abbreviated New Drug Applications --

Cranbury, NJ, May 23, 2005 – Able Laboratories, Inc. (NASDAQ: ABRX) announced today that it has suspended its manufacturing operations and recalled its product line.

FDA Talk Paper - May 20, 2005

FDA Warns Against Abuse of Dextromethorphan (DXM)

The Food and Drug Administration (FDA) is concerned about the abuse of dextromethorphan (DXM), a synthetically produced ingredient found in many over-the-counter (OTC) cough and cold remedies. The agency is working with other health and law enforcement authorities to address this serious issue and warn the public of potential harm, after five recently reported deaths of teenagers that may be associated with the consumption of powdered DXM sold in capsules.