What's New on the FDA Drugs Site
July 31, 2015
- Baxter Initiates Voluntary Nationwide Recall Of One Lot Of Iv Solution Due To The Potential For Leaking Containers, Particulate Matter And Missing Port Protectors
- Dissolution Testing and Specification Criteria for Immediate-Release Solid Oral Dosage Forms Containing Biopharmaceutics Classification System Class 1 and 3 Drugs Guidance for Industry (PDF - 87KB)
- FDA Drug Shortages
- Secretin Synthetic Human (ChiRhoStim) Injection (Updated - Resolved)
- Pediatric Medical, Statistical, and Clinical Pharmacology BPCA and PREA Reviews (updated)
New and Generic Drug Approvals
July 30, 2015
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| 8-Mop | methoxsalen | Capsule;Oral | Valeant Pharm Intl | Manufacturing Change or Addition |
| Bio-Tropin | somatropin recombinant | Injectable;Injection | Ferring | Manufacturing Change or Addition |
| Etopophos Preservative Free | etoposide phosphate | Injectable;Injection | Bristol Myers Squibb | Labeling Revision |
| Eylea | aflibercept | Injectable; Injection | Regeneron Pharmaceuticals | Labeling Revision |
| Krystexxa | pegloticase | Injectable; Injection | Savient Pharms | Efficacy Supplement with Clinical Data to Support |
| Latuda | lurasidone hydrochloride | Tablet;Oral | Sunovion Pharms Inc | Manufacturing Change or Addition |
| Naprosyn | naproxen | Suspension;Oral | Pediapharm Inc | Manufacturing Change or Addition |
| Neupogen | filgrastim | Syringe | Amgen | Labeling Revision |
| Neupogen | filgrastim | Vial | Amgen | Labeling Revision |
| Oxsoralen | methoxsalen | Lotion;Topical | Valeant Pharm Intl | Manufacturing Change or Addition |
| Pletal | cilostazol | Tablet;Oral | Otsuka | Labeling Revision |
| Proair Respiclick | albuterol sulfate | Powder, Metered;Inhalation | Teva Branded Pharm | Manufacturing Change or Addition |
| Valium | diazepam | Tablet;Oral | Roche | Manufacturing Change or Addition |
| Viekira Pak (Copackaged) | dasabuvir sodium ; ombitasvir; paritaprevir; ritonavir | Tablet, Tablet;Oral | Abbvie Inc | Manufacturing Change or Addition |
| Zomacton | somatropin recombinant | Injectable;Injection | Ferring | Manufacturing Change or Addition |
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Monday, August 3, 2015
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