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drug applications
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FDA and EMA Have Announced The Launch of a Joint Initiative to Share Information
Dec 20, 2013The US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have announced the launch of a joint initiative to share information on inspections of bioequivalence studies submitted in support of generic drug approvals. ...
Tags: Generic Drug, Medicine
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Ranbaxy Laboratories Has Secured Approval From CDSCO
Oct 23, 2013Ranbaxy Laboratories has secured approval from India's Central Drugs Standard Control Organisation (CDSCO) to manufacture and sell 'Synriam' to treat uncomplicated malaria caused by Plasmodium vivax parasite in adult patients. Phase III ...
Tags: Ranbaxy Laboratories, Drug Synriam
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Pharmaceutical Signed a Deal to Acquire Certain Assets of Pernix Therapeutics' Subsidiary
Aug 13, 2013Pharmaceutical marketing, research and development company Breckenridge Pharmaceutical has signed a deal to acquire certain assets of Pernix Therapeutics' subsidiary, Cypress Pharmaceuticals, for $30m. The assets included in the agreement ...
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FDA Approved Updated Labeling for Purdue Pharma L.P.'s Reformulated OxyContin Tablets
Apr 25, 2013Posted by Jack Mans, Plant Operations Editor -- Packaging Digest, 4/23/2013 5:04:22 PM The U.S. Food and Drug Administration today approved updated labeling for Purdue Pharma L.P.'s reformulated OxyContin (oxycodone hydrochloride ...
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New Collapsible Box Which Is Suitable for All Round Drug Applications Was Launched
Apr 12, 2013German pharma packaging company August Faller has announced the launch of new collapsible box with integrated compartments for handling liquid and semi-solid medicines during transportation. According to the company, the single-piece ...
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FDA Has Approved Mylan Pharmaceuticals' Abbreviated New Drug Applications
Jan 4, 2013The US Food and Drug Administration (FDA) has approved Mylan Pharmaceuticals' abbreviated new drug applications (ANDA) for the generic equivalents to Merck's Maxalt MLT tablets and Maxalt tablets. Rizatriptan Benzoate orally ...
Tags: US, FDA, Mylan Pharmaceuticals, ANDA, Maxalt MLT tablets, Maxalt tablets
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Depomed's Lawsuits Against Watson Laboratories and Par Pharmaceutical in Relation to ANDAs
Dec 31, 2012Depomed's lawsuits against Watson Laboratories and Par Pharmaceutical in relation to Abbreviated New Drug Applications (ANDAs) for Gralise (gabapentin) have been dismissed. The company said that both the companies no longer sought ...
Tags: Depomed, Watson Laboratories, Par Pharmaceutical, lawsuit
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Janssen Research & Development Has Submitted Supplemental New Drug Applications
Dec 5, 2012Janssen Research & Development has submitted supplemental New Drug Applications (sNDAs) to the US Food and Drug Administration (FDA) for the use of Xarelto (rivaroxaban), an oral anticoagulant. Janssen said the drug is used to treat ...
Tags: Xarelto, rivaroxaban, DVT, pulmonary embolism, VTE
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Takeda Global Research & Development Center Has Resubmitted New Drug Applications
Dec 5, 2012Furiex Pharmaceuticals said Takeda Global Research & Development Center has resubmitted New Drug Applications (NDAs) to the US Food and Drug Administration (FDA) for alogliptin and fixed-dose combination therapy alogliptin and pioglitazone ...
Tags: Furiex Pharmaceuticals, NDAs, alogliptin and pioglitazone
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Takeda Receives Response From FDA Regarding Its New Drug Applications
Dec 4, 2012Takeda Pharmaceutical has received a complete response letter from the US Food and Drug Administration (FDA) regarding its new drug applications (NDAs) for alogliptin and the fixed-dose combination therapy alogliptin and pioglitazone. ...
Tags: FDA, alogliptin, clinical trial program
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Mylan Has Launched Lithium Carbonate Extended-Release Tablets USP
Nov 29, 2012Mylan has launched Lithium Carbonate Extended-release Tablets USP, 450 mg following the final approval from the US Food and Drug Administration (FDA). The drug is used to treat manic episodes of manic depressive illness. According to ...
Tags: Mylan, lithium carbonate extended-release tablets, treat manic episodes
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Mylan Has Introduced The Generic Version
Nov 29, 2012Mylan Pharmaceuticals has introduced the generic version of Schering-Plough's Clarinex allergy medication, Desloratadine tablets, 5mg. Mylan gained final FDA approval for its abbreviated new drug application for Desloratadine Tablets, ...
Tags: Generic Clarinex Tablets, Desloratadine tablets, drug applications
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US FDA Issues New Guidelines for Packaging
Oct 23, 2012The US Food and Drug Administration's (FDA) Center For Drug Evaluation and Research has issued new guidelines for the packaging of test batches manufactured for Abbreviated New Drug Applications (ANDA), Abbreviated Antibiotic Applications ...
Tags: FDA, food, drug, packaging, test batches, ANDA, labeling
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Sunovion Pharmaceuticals Has Submitted Two Supplemental New Drug Applications
Sep 7, 2012Sunovion Pharmaceuticals has submitted two supplemental new drug applications (sNDAs) to the FDA seeking approval for the use of LATUDA (lurasidone HCl) as monotherapy and adjunctive therapy in adult patients with depressive episodes ...
Tags: FDA, sNDA, atypical class of drugs, bipolar depression
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