---------- Forwarded message ----------
From: U.S. Food & Drug Administration (FDA) <fda@service.govdelivery.com>
Date: Mon, Jul 28, 2014 at 5:18 AM
Subject: CDER New July 28, 2014
To: iammejtm@gmail.com
From: U.S. Food & Drug Administration (FDA) <fda@service.govdelivery.com>
Date: Mon, Jul 28, 2014 at 5:18 AM
Subject: CDER New July 28, 2014
To: iammejtm@gmail.com
What's New on the FDA Drugs Site
July 25, 2014
- Drug Firm Annual Registration Status (updated)
- Drug Firm Annual Registration Status Download File (updated)
- FDA Drug Shortages: New and Updated
- Fluorescein Sodium Injection (Currently in Shortage)
- Guidance for Industry: Providing Regulatory Submissions in Electronic Format — Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications (PDF - 105KB)
- National Drug Code Directory
- Pediatric Medical, Statistical, and Clinical Pharmacology BPCA and PREA Reviews (updated)
New and Generic Drug Approvals
July 24, 2014
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Adderall Xr 10 | amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate | Capsule, Extended Release;Oral | Shire | Labeling Revision |
| Adderall Xr 15 | amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate | Capsule, Extended Release;Oral | Shire | Labeling Revision |
| Adderall Xr 20 | amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate | Capsule, Extended Release;Oral | Shire | Labeling Revision |
| Adderall Xr 25 | amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate | Capsule, Extended Release;Oral | Shire | Labeling Revision |
| Adderall Xr 30 | amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate | Capsule, Extended Release;Oral | Shire | Labeling Revision |
| Adderall Xr 5 | amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate | Capsule, Extended Release;Oral | Shire | Labeling Revision |
| Crixivan | indinavir sulfate | Capsule;Oral | Merck Sharp Dohme | Labeling Revision |
| Fortical | calcitonin salmon recombinant | Spray, Metered;Nasal | Upsher Smith | Manufacturing Change or Addition |
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Jeremy Tobias Matthews
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