FDA Approves First Bone Marrow Stimulator to Treat Immune-Related Low Platelet Counts
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- Category: FDA
The U.S. Food and Drug Administration approved Nplate (romiplostim), the first product that directly stimulates the bone marrow to produce needed platelets in patients with a rare blood disorder that can lead to serious bleeding.
European Medicines Agency recommends restricting the use of oral moxifloxacin-containing medicines
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- Category: EMA
Finalising a review of the safety of moxifloxacin-containing medicines for oral use, the European Medicines Agency (EMEA) has concluded that these medicines should only be prescribed in the treatment of acute bacterial sinusitis, acute exacerbation of chronic bronchitis and community-acquired pneumonia when other antibiotics cannot be used or have failed.
EMEA recommendation on use of angiotensin II receptor antagonists during pregnancy
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- Category: EMA
The European Medicines Agency (EMEA) has recommended that the product information of all centrally authorised angiotensin II receptor antagonists be harmonised, regarding their use during pregnancy. Following a review of the safety of these medicines during pregnancy, the EMEA's Committee for Medicinal Products for Human Use (CHMP), at its April 2008 meeting, recommended that the product information should state that the use of angiotensin II receptor antagonists should be avoided in the first three months of pregnancy.
FDA Issues Alert on Tussionex, a Long-Acting Prescription Cough Medicine Containing Hydrocodone
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- Category: FDA
The U.S. Food and Drug Administration issued an alert today on the safe and correct use of Tussionex Pennkinetic Extended-Release Suspension in response to numerous reports of adverse events - including death - associated with the misuse and inappropriate use of this potent cough medication.
Wyeth Europa Ltd withdraws its marketing authorisation application for Pristiqs (desvenlafaxine)
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- Category: EMA
The European Medicines Agency (EMEA) has been formally notified by Wyeth Europa Ltd of its
decision to withdraw the application for a centralised marketing authorisation for the medicine Pristiqs
(desvenlafaxine) 50mg and 100mg prolonged release tablets.
Actelion withdraws its application for an extension of indication for Zavesca
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- Category: EMA
The European Medicines Agency (EMEA) has been formally notified by Actelion of its decision to withdraw its application for an extension of indication for the centrally authorised medicine Zavesca (miglustat).
FDA Licenses New Hemophilia Treatment
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- Category: FDA
The U.S. Food and Drug Administration licensed a treatment for hemophilia A, a rare, hereditary blood-clotting disorder that affects approximately 15,000 individuals, almost exclusively males, in the United States.
More Pharma News ...
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- EMEA recommends new warnings and contraindications for rosiglitazone
- EMEA recommends withdrawal of marketing authorisations for cough medicines containing clobutinol
- FDA Warns Procter & Gamble about Unlawful Marketing of Product for School Children
- FDA Approves New Uses for Evista