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FDA News - May 18, 2005

FDA Continues Combating Counterfeit Drugs

Annual Update Reports on Progress

Rockville, MD -- Working in collaboration with the private sector and with other government agencies over the past year, the Food and Drug Administration (FDA) is announcing significant progress in the battle against counterfeit prescription drugs. In its annual update to the "Combating Counterfeit Drugs" Report, the FDA reports it is pursuing several initiatives to further protect the safety and integrity of the U.S. drug supply.

"We believe the United States' prescription drug supply is as safe as any in the world, and the FDA is committed to ensuring that this continues," said Randall Lutter, Acting Associate Commissioner for Policy and Planning.

FDA Talk Paper - May 10, 2005

FDA Warns Consumers About Counterfeit Drugs Purchased in Mexico

The Food and Drug Administration (FDA) is warning the public about the sale of counterfeit versions of Lipitor, Viagra, and an unapproved product promoted as "generic Evista" to U.S. consumers at pharmacies in Mexican border towns.

Consumers who have any of these counterfeit products should not use them and should contact their healthcare provider immediately. FDA is warning consumers that prescription drugs purchased in foreign countries are not regulated by the FDA and do not carry the same FDA assurances of safety, effectiveness, and manufacturing quality as drugs purchased within the United States.

Par Pharmaceutical Receives Approval to Market Generic Ultracet®

Spring Valley, New York, April 22, 2005 — Par Pharmaceutical Companies, Inc. (NYSE:PRX) today announced that its wholly-owned subsidiary, Kali Laboratories, Inc., has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for tramadol hydrochloride (HCl) and acetaminophen tablets. Kali has been awarded 180 days of marketing exclusivity, commencing at launch, for being the first to file an ANDA containing a paragraph IV certification for the product. Ortho-McNeil Pharmaceutical, Inc. currently markets 37.5 mg tramadol HCl/325 mg acetaminophen tablets under the brand name Ultracet®. The product is indicated for the short-term (five days or less) management of acute pain and has annual U.S. sales of approximately $350 million.

Complete press release is available at Par Pharmaceutical

This is not a new drug but it is the first generic Ultracet. Pharmer.org usually doesn't report on first-time generics. In this case, though, it seemed appropriate since we do provide pill identification imprints for most brands of tramadol without acetaminophen in our Imprints of Opioid Analgesics.

The FDA announced today that Pfizer has agreed to withdraw Bextra (valdecoxib) from the US and European markets.

In addition, the FDA is requesting all manufacturers of prescription and over-the-counter non-steroidal anti-inflammatory drugs (NSAIDs) to make labeling changes to include more information about the potential cardiovascular and gastrointestinal risks associated with the NSAIDs.

Complete information is available at FDA Public Health Advisory - COX-2 Selective and Non-Selective Non-Steroidal Anti-Inflammatory Drugs

FDA Med Watch posted March 16, 2005:

Avonex (interferon beta-1a)
Audience: Neurologists and other healthcare professionals

FDA and Biogen notified healthcare professionals of revisions to the WARNINGS, PRECAUTIONS/Drug Interactions and ADVERSE REACTIONS/Post-Marketing Experience sections and Medication Guide. Severe hepatic injury, including cases of hepatic failure, has been reported in patients taking Avonex. Asymptomatic elevation of hepatic transaminases has also been reported, and in some patients has recurred upon rechallenge.

FDA Approves CLARINEX-D 24 HOUR Prescription-Strength Once-Daily Nondrowsy Antihistamine with a Decongestant

Unique Gel Control delivery system provides effective 24-hour relief

Excerpt from Schering-Plough press release:

KENILWORTH, N.J., March 4, 2005 /PRNewswire-FirstCall via COMTEX/ -- Schering-Plough Corporation (NYSE: SGP) today announced that the U.S. Food and Drug Administration (FDA) has approved CLARINEX-D 24 HOUR (desloratadine 5mg and pseudoephedrine sulfate USP 240 mg) Extended Release Tablets for the relief of the nasal and non-nasal symptoms of seasonal allergic rhinitis (outdoor allergies), including nasal congestion, in patients 12 years of age and older.

FDA ALERT [03/02/2005]

Rhabdomyolysis (serious muscle damage) has been reported in patients taking Crestor as well as other statin drugs. To date, it does not appear that the risk is greater with Crestor than with other marketed statins. However, the labeling for Crestor is being revised to highlight important information on the safe use of Crestor to reduce the risk for serious muscle toxicity (myopathy/rhabdomyolysis), especially at the highest approved dose of 40 mg.

Excerpt of "Dear Healthcare Professional letter" from Biogen Idec and Elan:

IMPORTANT DRUG WARNING
VOLUNTARY SUSPENSION OF
TYSABRI® (natalizumab) MARKETING

February 28, 2005

Dear Healthcare Professional,

Biogen Idec and Elan Pharmaceuticals are announcing a voluntary suspension in the marketing of TYSABRI, a multiple sclerosis therapy. We are suspending supply of TYSABRI from commercial distribution and physicians should suspend dosing of TYSABRI until further notification. In addition, we have suspended dosing in all clinical trials. These actions, which we believe are in the best interest of patients, have been taken in consultation with FDA. You will be notified regarding the procedure for returning unused product.

On February 22, 2005, the FDA approved Pfizer's CARDURA XL, an extended-release formulation of doxazosin mesylate. CARDURA XL will be available in 4 mg and 8 mg dosage strengths.

CARDURA XL is indicated for the treatment of non-cancerous enlargement of the prostate gland (benign prostatic hyperplasia).

CARDURA XL is not approved nor is it indicated for the treatment of hypertension.

CARDURA XL is new to the US market although the drug has been available in several European countries.

FDA ALERT [02/18/2005] – Seizures in Patients Without Epilepsy

Today the Food and Drug Administration announced that a bolded Warning will be added to the labeling for Gabitril (tiagabine) to warn prescribers of the risk of seizures in patients without epilepsy being treated with this drug. Although Gabitril has been shown to reduce the frequency of seizures in patients with epilepsy, paradoxically, Gabitril’s use has been associated with the occurrence of seizures in patients without epilepsy. Gabitril is approved for use only as adjunctive therapy in adults and children 12 years and older in the treatment of partial seizures. Because Gabitril has not been systematically evaluated in adequate and well-controlled trials for any other indication, its safety and effectiveness have not been established for any other use.