Generic Fosamax Approved
February 7, 2008
Teva Pharmaceuticals announced that the U.S. Food and Drug Administration has granted final approval for the ANDA to market its generic version of Merck’ s Fosamax in 5 mg, 10 mg, 35 mg, 40 mg and 70 mg strengths. Shipment of the product will begin immediately.As the first company to file an ANDA containing a paragraph IV certification for this product, Teva has been awarded a 180-day period of marketing exclusivity.
Fosamax had annual sales of approximately $1.9 billion in America.
Public Health Advisory on Chantix
February 7, 2008
After sending out an Early Communication in November 2007 regarding reports of suicidality in patients taking varenicline, the agency now says there is reason to be concerned. Following review of the reports, it seems increasingly likely that the abnormal behavior, such as changes in mood, agitation, depression, and suicidal thoughts, is due to exposure to the drug and not to other causes. As a result of the findings, Read more
Cough Syrup cited in death of rapper
February 6, 2008
The death of the influential Southern rapper Pimp C, below, has been ruled an accident attributable to an overdose of drugs celebrated by Three 6 Mafia and the Pimp C group Underground Kingz in the 2000 single “Sippin’ on Some Syrup,” The Associated Press reported. The Los Angeles County coroner’s office identified the drugs as codeine and promethazine, essential ingredients of “syrup.” The coroner’s office said Pimp C, whose real name was Chad Butler, had sleep apnea, an ailment that can cause breathing during sleep to stop for as long as 30 seconds. Capt. Ed Winter of the coroner’s office said that sleep apnea, combined with large amounts of prescription-strength cough syrup, killed Pimp C on Dec. 4 in West Hollywood, Calif. He was 33.
Article Via New York Times. News Thanks to Kevin in our forums.
Once-daily amoxicillin approved
January 25, 2008
Moxatag 775 mg (amoxicillin extended-release, MiddleBrook Pharmaceuticals) has been approved to treat adults and children 12 and older with pharyngitis and/or tonsillitis secondary to strep throat. MiddleBrookclaims that its product is the first once-daily amoxicillin product approved in this country. Its convenient dosing should ensure better drug compliance.
OrthoEvera gets new warning
January 21, 2008
FDA modified the prescribing information for the Ortho Evra Contraceptive Transdermal (Skin) Patch to include the results of a new epidemiology study that found that users of the birth control patch were at higher risk of developing serious blood clots, also known as venous thromboembolism (VTE), than women using birth control pills. VTE can lead to pulmonary embolism. The label changes are based on a study conducted by the Boston Collaborative Drug Surveillance Program on behalf of Johnson and Johnson. The patch was studied in women aged 15-44. These findings support an earlier study that also said women in this group were at higher risk for VTE.
[Via FDA MedWatch]
Study Shows Zetia Doesn’t Cut Heart Attack Risk
January 15, 2008
Results from a study previously being held from the public were released showing that Zetia, an anti-hyperlipidemic medication, has been proved to provide “no medical Benefit” to patients.
Click For HealthDay report.
Watson Gets Positive Results With New Oxybutinin Topical Gel
January 8, 2008
Phase 3 study results from its pivotal study of Oxybutynin Topical Gel for the treatment of overactive bladder appear promising.
“We are extremely encouraged with the results from this trial which will support our NDA submission, and we are on track to file with FDA in the second quarter of 2008,” said Paul Bisaro, Watson’s President and Chief Executive Officer. “Additionally, we have the potential to introduce the first gel formulation for the treatment of overactive bladder in 2009.”
Complete article found here.
FDA panel not recommending OTC use of Mevacor.
December 17, 2007
A FDA advisory panel voted against recommending the approval of OTC use of Merck’s cholesterol-lowering drug Mevacor (Lovastatin).
The recommendation was made Thursday night by a joint panel of the FDA’s Nonprescription Drugs Advisory Committee and the Endocrinologic and Metabolic Drugs Advisory Committee.
Panel members expressed concerns that too many people who were not the right candidates for the medicine, and would likely not benefit from it, would buy the drug if it was made available without a prescription.
The FDA is not bound by the committee’s recommendation, but the agency typically flows the advice of its committee. A final vote of Merck’s request is expected by Jan. 26.
[via Philadelphia Business Journal]
Avandia gets Black-Box Warning
November 15, 2007
The FDA has ruled that the diabetes drug Avandia must now carry a “black box” label warning that the drug may increase a person’s risk of heart attack and angina.
The action follows the recommendation of the FDA’s outside advisory panel. The panel last July voted 22-1 against removing the drug from the market, but said the drug’s label should carry a stronger warning.
The FDA decision against an Avandia ban came after a split vote from its own internal safety review board.
In August, the FDA announced that all thiazolidinedione diabetes drugs — the class of drugs including Avandia, Actos, Avandaryl, Avandamet, and Duetact — would carry a black-box warning that the drugs may cause or worsen heart failure in some patients.
Avandia will now carry an additional black-box warning. The warning alerts patients and doctors to troubling but inconclusive evidence that the drug may increase a patient’s risk of heart attack and angina.
Avandia’s new label also notes that the drug is not recommended — but not contraindicated — for patients already taking insulin or nitrate drugs.
[Via Web-MD]
Over-the-Counter Zyrtec-D Approved
November 15, 2007
The FDA has officially announced its approval of a nonprescription Zyrtec-D.
Available as a prescription drug since 2001, Zyrtec-D is now approved as an over-the-counter drug for the relief of symptoms due to hay fever or other upper respiratory allergies such as runny nose; sneezing; itchy, watery eyes; itchy nose or throat; and nasal congestion.
“The approval of this widely used drug for nonprescription use will enable many people to have access to another effective treatment for their allergy symptoms,” says Andrea Leonard-Segal, MD, in an FDA news release.
Sales of the drug are subject to restrictions in the Combat Methamphetamine Epidemic Act, and technically must be kept “Behind the Counter”
[Via Web-MD]
