New from
CDER
• August
20. FDA updates its review of antidepressant
drugs in children. FDA’s next step will be to update
the Psychopharmacologic Drugs and the Pediatric
Advisory Committees about the results of these reviews
and consider what additional regulatory actions may be
needed to promote the safe use of these drugs.
FDA Talk Paper.
• August
20. FDA approves Alimta (pemetrexed for
Injection) as a single-agent for the treatment of
patients with locally advanced or metastatic non-small
cell lung cancer after prior chemotherapy.
• August
17. FDA and Aventis Pharmaceuticals revise the
labeling for Lovenox, describing the need for a dosage
adjustment for patients with severe renal impairment
who have increased exposure to enoxaparin.
MedWatch Safety Info.
• August
13. FDA and Genentech, Inc. issue an important
drug warning to healthcare providers that there is
evidence of an increased risk of serious arterial
thromboembolic events related to Avastin.
MedWatch Safety Info.
• August
11. FDA Approves Drugs to Treat Internal
Contamination from Radioactive Elements.
More Info
• August
10. FDA approves Esmolol Hydrochloride Injection, a beta-selective (cardioselective) adrenergic receptor blocking agent with a very short duration of action.
The reference listed drug is Brevibloc Injection of Baxter Healthcare.
• August
10. FDA approves first-time generic Levocarnitine Oral Solution, 1g/10mL, for the treatment of
carnitine deficiency. The reference listed drug is Carnitor Oral Solution.
• August
6. FDA approves first-time generic Ciclopirox
Topical Suspension USP, 0.77% (lotion) as a topical
antifungal. The reference listed drug is Loprox
Topical Suspension, 0.77% of Medicis Pharmaceutical
Corp.
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