What's New on the FDA Drugs Site
July 28, 2014
- Medication Guides Page (Updated)
- Drug Firm Annual Registration Status (updated)
- Drug Firm Annual Registration Status Download File (updated)
- FDA expands approved use of Imbruvica (ibrutinib) for chronic lymphocytic leukemia
- National Drug Code Directory
- Pediatric Medical, Statistical, and Clinical Pharmacology BPCA Reviews (updated)
New and Generic Drug Approvals
July 25, 2014
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Acticlate | doxycycline hyclate | Tablet;Oral | Aqua Pharms | Approval |
| Adrenaclick | epinephrine | Injectable;Intramuscular, Subcutaneous | Amedra Pharms | Labeling Revision |
| Alinia | nitazoxanide | For Suspension;Oral | Romark | Manufacturing Change or Addition |
| Apokyn | apomorphine hydrochloride | Injectable;Subcutaneous | Us Worldmeds | Labeling Revision |
| Azactam In Plastic Container | aztreonam | Injectable;Injection | Bristol Myers Squibb | Manufacturing Change or Addition |
| Biaxin | clarithromycin | Tablet;Oral | Abbvie | Labeling Revision |
| Biaxin | clarithromycin | For Suspension;Oral | Abbvie | Labeling Revision |
| Biaxin Xl | clarithromycin | Tablet, Extended Release;Oral | Abbvie | Labeling Revision |
| Children's Claritin | loratadine | Tablet, Chewable;Oral | Schering Plough | Labeling Revision |
| Habitrol | nicotine | Film, Extended Release; Transdermal | Novartis | Labeling Revision |
| Habitrol | nicotine | Film, Extended Release;Transdermal | Novartis | Labeling Revision |
| Jakafi | ruxolitinib phosphate | Tablet;Oral | Incyte Corp | Efficacy Supplement with Clinical Data to Support |
| Lastacaft | alcaftadine | Solution/Drops;Ophthalmic | Allergan | Manufacturing Change or Addition |
| Mestinon | pyridostigmine bromide | Tablet, Extended Release;Oral | Valeant Pharms Llc | Manufacturing Change or Addition |
| Pradaxa | dabigatran etexilate mesylate | Capsule;Oral | Boehringer Ingelheim | Manufacturing Change or Addition |
| Prevantics Maxi Swabstick | chlorhexidine gluconate; isopropyl alcohol | Swab;Topical | Prof Dspls | Labeling Revision |
| Prevantics Swab | chlorhexidine gluconate; isopropyl alcohol | Swab;Topical | Prof Dspls | Labeling Revision |
| Prevantics Swabstick | chlorhexidine gluconate; isopropyl alcohol | Swab;Topical | Prof Dspls | Labeling Revision |
| Twinject 0.15 | epinephrine | Injectable;Intramuscular, Subcutaneous | Amedra Pharms | Labeling Revision |
| Twinject 0.3 | epinephrine | Injectable;Intramuscular, Subcutaneous | Amedra Pharms | Labeling Revision |
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