Search results for "FDA update"
Benefits of bisphosphonates after five years debated
Bisphosphonate treatment that continues beyond five years might not provide additional fracture prevention benefit, concluded a review by the FDA.
https://immattersacp.org/weekly/archives/2012/05/15/7.htm
15 May 2012
Generic irbesartan, escitalopram, ibandronate approved
This regulatory update includes a revision to the label of drospirenone-containing contraceptives and approval of the first generic versions of Avapro (irbesartan) and Avalide (irbesartan and hydrochlorothiazide) tablets for the treatment of high blood pressure.
https://immattersacp.org/archives/2012/06/fda.htm
1 Jun 2012
Cautions about mixing HIV, HCV drugs
This regulatory update covers a warning about giving boceprevir with some ritonavir-boosted HIV protease inhibitors, as well as approval of a new erectile dysfunction drug.
https://immattersacp.org/archives/2012/07/fda.htm
1 Jul 2012
Troponin and other diagnostic tests recalled
A number of cardiovascular diagnostic tests are being recalled for possible inaccuracy of their results, the FDA announced last week.
https://immattersacp.org/weekly/archives/2012/07/17/7.htm
17 Jul 2012
Weight-loss drug and at-home HIV test approved
This regulatory update covers approval of lorcaserin HCl for chronic weight management, as well as a new at-home mouth swab test for HIV 1 and 2.
https://immattersacp.org/archives/2012/09/fda.htm
1 Sep 2012
HIV prophylaxis and new weight loss drug approved
This regulatory update covers label changes for dalfampridine and approvals for the first generic versions of montelukast sodium for asthma.
https://immattersacp.org/archives/2012/10/fda.htm
1 Oct 2012
Generic pioglitazone, new HIV combination pill approved
This regulatory update covers approvals of the first generic form of pioglitazone and a combination form of emtricitabine, tonofavir and two new drugs for patients new to HIV treatment.
https://immattersacp.org/archives/2012/11/fda.htm
1 Nov 2012
All Ameridose unexpired products recalled
All unexpired products distributed by Ameridose, LLC, are being recalled, the FDA announced last week.
https://immattersacp.org/weekly/archives/2012/11/06/7.htm
6 Nov 2012
Ondansetron 32-mg dose pulled from market
The 32-mg, single intravenous dose of ondansetron hydrochloride (Zofran) has been pulled from the market due to its cardiac risks, the FDA recently announced.
https://immattersacp.org/weekly/archives/2012/12/11/9.htm
11 Dec 2012
Expanded approval on rivaroxaban, reassurance on dabigatran
This regulatory update covers an expanded indication for rivaroxaban and an announcement that bleeding rates do not appear to be higher with dabigatran than with warfarin.
https://immattersacp.org/archives/2013/01/fda.htm
1 Jan 2013