---------- Forwarded message ----------
From: U.S. Food & Drug Administration (FDA) <fda@service.govdelivery.com>
Date: Tue, Jul 1, 2014 at 4:42 AM
Subject: CDER New June 30
To: iammejtm@gmail.com
From: U.S. Food & Drug Administration (FDA) <fda@service.govdelivery.com>
Date: Tue, Jul 1, 2014 at 4:42 AM
Subject: CDER New June 30
To: iammejtm@gmail.com
What's New on the FDA Drugs Site
July 30
- FDA Drug Shortages: New and Updated
- Levofloxacin (LEVAQUIN) Injection (Discontinuation)
- Levofloxacin (LEVAQUIN) Oral Solution (Discontinuation)
-
- Drug Firm Annual Registration Status (updated)
- Drug Firm Annual Registration Status Download File (updated)
- FDA approves Afrezza (insulin human) to treat diabetes
- Meeting Presentation: Will Government encourage innovation for the development of abuse deterrent formulations? (PDF - 370KB)
- National Drug Code Directory
- Pediatric Medical, Statistical, and Clinical Pharmacology BPCA Reviews (updated)
New and Generic Drug Approvals
June 28, 2014
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Ozurdex | dexamethasone | Implant;Intravitreal | Allergan | New or Modified Indication |
| Symbicort | budesonide; formoterol fumarate dihydrate | Aerosol, Metered;Inhalation | Astrazeneca | Manufacturing Change or Addition |
June 27, 2014
| Drug Name | Active Ingredient | Dosage Form/Route | Sponsor | Submission Type |
|---|---|---|---|---|
| Afrezza | insulin human | Powder;Inhalation | Mannkind Corp | Approval |
| Ammonia N-13 | ammonia n-13 | Injectable;Intravenous | Univ Tx Md Anderson | Approval |
| Benicar | olmesartan medoxomil | Tablet;Oral | Daiichi Sankyo | Labeling Revision |
| Benicar Hct | hydrochlorothiazide; olmesartan medoxomil | Tablet;Oral | Daiichi Sankyo | Labeling Revision |
| Buprenorphine Hydrochloride and Naloxone Hydrochloride | buprenorphine hydrochloride; naloxone hydrochloride | Tablet;Sublingual | Roxane | Approval |
| Buprenorphine Hydrochloride and Naloxone Hydrodhcloride | buprenorphine hydrochloride; naloxone hydrochloride | Tablet;Sublingual | Roxane | Approval |
| Ceretec | technetium tc-99m exametazime kit | Injectable;Injection | Ge Healthcare | Manufacturing Change or Addition |
| Desmopressin Acetate | desmopressin acetate | Tablet;Oral | Mylan Pharms Inc | Approval |
| Doxorubicin Hydrochloride | doxorubicin hydrochloride | Injectable;Injection | Actavis Inc | Approval |
| Eletriptan Hydrobromide | eletriptan hydrobromide | Tablet; Oral | Teva Pharms Usa | Tentative Approval |
| Ella | ulipristal acetate | Tablet;Oral | Lab Hra Pharma | Manufacturing Change or Addition |
| Furosemide | furosemide | Injectable;Injection | Luitpold | Manufacturing Change or Addition |
| Gazyva | obinutuzumab | Injectable;Injection | Genentech | Labeling Revision |
| Lupron Depot | leuprolide acetate | Injectable;Injection | Abbvie Endocrine Inc | Labeling Revision |
| Lupron Depot | leuprolide acetate | Injectable;Injection | Abbvie Endocrine Inc | Labeling Revision |
| Oxymorphone Hydrochloride | oxymorphone hydrochloride | Tablet, Extended Release;Oral | Mallinckrodt Inc | Approval |
| Symlin | pramlintide acetate | Injectable;Subcutaneous | Astrazeneca Ab | Efficacy Supplement with Clinical Data to Support |
| Symlin | pramlintide acetate | Injectable;Subcutaneous | Astrazeneca Ab | Labeling Revision |
| Taxol | paclitaxel | Injectable;Injection | Hq Spclt Pharma | Manufacturing Change or Addition |
| Tribenzor | amlodipine besylate; hydrochlorothiazide; olmesartan medoxomil | Tablet;Oral | Daiichi Sankyo | Labeling Revision |
| Vazculep | phenylephrine hydrochloride | Injectable; Injection | Eclat Pharms Llc | Approval |
| Virazole | ribavirin | For Solution;Inhalation | Valeant Pharm Intl | Manufacturing Change or Addition |
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Jeremy Tobias Matthews
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