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FDA Requests Boxed Warning for Contrast Agents Used to Improve MRI Images
The U.S. Food and Drug Administration (FDA) has asked manufacturers to include a new boxed warning on the product labeling of all gadolinium-based con...

FDA Takes Action to Stop Marketing of Unapproved Timed-Release Guaifenesin Drug Products
The U.S. Food and Drug Administration (FDA) announced its intention to take action against companies that market unapproved drug products in timed-rel...

FDA Approves First New Oral Treatment for Bacterial Vaginosis
Mission Pharmacal announced that the U.S. Food and Drug Administration (FDA) approved Tindamax (tinidazole) for the treatment of bacterial vaginosis (...

FDA Approves Wyeth's Oral Contraceptive Lybrel
FDA has approved Wyeth's oral contraceptive Lybrel, which is designed to eliminate monthly menstrual periods, the Los Angeles Times reports. Lybrel, w...

Novagali Pharma Receives US FDA Orphan Drug Designation for Vekacia(R) for the Treatment of Vernal Keratoconjunctivitis
Novagali Pharma, an emerging ophthalmic pharmaceutical company, announced orphan drug designation granted by the U.S. Food and Drug Administration (FD...

FDA Approves Astrazeneca's Once-Daily Seroquel XR Extended-Release Tablets for the Treatment of Schizophrenia
AstraZeneca announced that the FDA has approved SEROQUEL XR (quetiapine fumarate) Extended-Release Tablets, a once-daily medicine for the treatment of...

FDA Approves Lovenox (Enoxaparin Sodium Injection) for the Most Severe Type of Heart Attack
Sanofi-aventis announced that the FDA has approved a supplemental New Drug Application (sNDA) for the anticoagulant Lovenox (enoxaparin sodium injecti...

Casewise Earns the Highest Score for its 'Current Offering' in Enterprise Architecture Modeling Software
Casewise announced that it was named a leader and earned the top score for its 'Current Offering' in the recently published independent market assess...

FDA Approves Dey, L.P.'s Perforomist Inhalation Solution For Maintenance Treatment Of COPD
Dey has announced that the FDA has approved its New Drug Application (NDA) for Perforomist (formoterol fumarate) Inhalation Solution for long-term, tw...

FDA Approves Expanded Use for Surgical Sealant
The U.S. Food and Drug Administration (FDA) approved Evicel Fibrin Sealant, a liquid product that when applied topically helps control oozing from sma...

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