Approvals

First-Time Generic Approvals: Maxipime, Tessalon 200 mg, Vesanoid The FDA has approved generic formulations for cefepime hydrochloride 500 mg, 1-g, and 2-g base/vial for parenteral administration in the treatment of bacterial infections; benzonatate 200 mg for the treatment of cough; and tretinoin 10-mg capsules for the induction of remission in patients with acute promyelocytic leukemia (APL).
News, July 26, 2020
First-Time Generic Approvals: AccuNeb, Coreg, Famvir The FDA has approved first-time generic formulations for albuterol sulfate inhalation solution in the 0.021% (base) strength; carvedilol 3.125-, 6.25-, 12.5-, and 25-mg tablets; and famciclovir 125-, 250-, and 500-mg tablets.
News, July 26, 2020
New FDA Orphan Drugs: Levulan, Vekacia, Hexarelin Analog The FDA has granted orphan drug designation for aminolevulinic acid HCl in combination with photodynamic therapy, a cyclosporine A drug, and a peptidomimetic analog of hexarelin.
News, July 26, 2020
New FDA Orphan Drugs: Sodium Phenylbutyrate, MGCD0103, Bendamustine HCl The FDA has granted orphan drug designation for sodium phenylbutyrate for the treatment of spinal muscular atrophy, MGCD0103 for the treatment of Hodgkin's lymphoma, and bendamustine HCl for the treatment of chronic lymphocytic leukemia.
News, July 26, 2020
New FDA Orphan Drugs: VariZIG, Pafuramidine Maleate, RG1068 The FDA has granted orphan drug status for varicella zoster immune globulin [human] injection, pafuramidine maleate, and synthetic human secretin.
News, July 26, 2020
New FDA Orphan Drugs: MGA031, KBPA101, TLF Oral Solution The FDA has approved orphan drug status for the humanized Fc-engineered anti-CD3 monoclonal antibody hOKT3-gamma-1 (Ala-Ala; MGA031), a fully human monoclonal antibody (KBPA101), and an oral solution formulation of talactoferrin alfa (TLF).
News, July 26, 2020
New FDA Orphan Drugs: CellCept, Prochymal, Shiga Toxin Antibodies The FDA has approved orphan drug indications for mofetil (CellCept), an adult stem cell product (Prochymal), and 2 chimeric anti-Shiga toxin antibodies (caStx1 and caStx2).
News, July 26, 2020
New FDA Orphan Drugs: Cethromycin, Maribavir, rhPDGF-BB The FDA has granted orphan drug designation for cethromycin, maribavir, and recombinant human platelet-derived growth factor (rhPDGF-BB).
News, July 26, 2020
New FDA Orphan Drugs The FDA has granted orphan drug designation for mifepristone for the treatment of Cushing's syndrome, 1-deoxynojirimycin hydrochloride for the treatment of Pompe disease, and cetuximab for the treatment of pancreatic cancer.
News, July 26, 2020
New FDA Orphan Drugs: Ganciclovir and Tissue Repair Cells The FDA has granted orphan drug designation for ganciclovir ophthalmic gel in the treatment of acute herpetic keratitis and tissue repair cells in the treatment of dilated cardiomyopathy.
News, July 26, 2020
Alert FDA: Antidepressant Labels Must Warn of Suicidality Risk in Young Adults The US Food and Drug Administration gave antidepressant manufacturers 30 days to update warnings of suicidality in young adults aged 18 to 24 years.
News, July 25, 2020
Alert Cardiovascular Risks of Haloperidol Highlighted The FDA and Johnson & Johnson have informed healthcare professionals that prescribing information for haloperidol has been revised to include a new cardiovascular subsection following case reports of sudden death, QT prolongation, and torsades de pointes.
News, July 25, 2020
Alert FDA Reviewing Proton-Pump Inhibitor Safety Suggestions of increased CV risk from Prilosec and Nexium in several clinical trials appear inconsistent with other data on the drugs, says the agency, which continues to study the issue.
News, July 25, 2020
Alert Globus Media Home Medical Tests Illegal, Untested, and May Be Inaccurate Tests have not been evaluated for accuracy or approved by the FDA, and may produce false results.
News, July 25, 2020
Alert FDA Approves SGLT2 Inhibitor Ertugliflozin for Type 2 Diabetes The US Food and Drug Administration has approved ertugliflozin, a fourth SGLT2 inhibitor for use in adults with type 2 diabetes .
News, December 21, 2017
FDA Warns About Amputation Risk With Canagliflozin UPDATED // The agency is investigating whether the twofold increase in amputations seen in an ongoing trial is attributable to the drug.
News, May 18, 2016
New Continuous Glucose Monitor Software Improves Accuracy The US Food and Drug Administration (FDA) has approved new software for the Dexcom G4 Platinum system that the company says brings its accuracy close to that of finger-stick testing.
News, November 12, 2014
Alert Trametinib (Mekinist) Now Approved in EU for Melanoma The first MEK-inhibitor is now approved, specifically for use as a single agent in adults with unresectable or metastatic melanoma and BRAF mutations.
News, July 04, 2014
Alert FDA Rejects Novo Nordisk's Insulin Degludec The FDA has told Novo Nordisk that it wants more cardiovascular outcomes data on its long-acting basal insulin degludec; the company says it will not be able to provide the information this year.
News, February 11, 2013
Alert FDA Approves Higher Dose of Hydromorphone The FDA has approved a 32-mg tablet strength of hydromorphone HCI extended-release tablets (Exalgo, Mallinckrodt) for moderate to severe chronic pain.
News, August 29, 2012

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