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ANDA Approvals - New Drug Applications and 505(b)(2) Applications: Third Quarter
15 Nov 2024 22:16 GMT
Approval Date
Reference Listed Drug
Generic Drug Name
NDA Holder
…
Endari
L-Glutamine
Emmaus Medical
Novitium Pharma
215647
07… #47;26/2024
Relistor
Methylnaltrexone Bromide
Salix
Actavis
…
Tarceva
Erlotinib HCl
OSI Pharmaceuticals
Hikma
203843
09…
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Salix Pharmaceuticals Announces a Phase 2 Investigator-Initiated Study of RELISTOR in Patients with Resectable Head and Neck Squamous Cell Carcinoma
06 Mar 2024 21:05 GMT
… Cancer Center. The trial is designed to … Medical Affairs, said. "Having Dr. Cata study this drug … RELISTOR tablets and RELISTOR injection are indicated for the treatment of … for RELISTOR tablets and RELISTOR injection.
About Salix
Salix Pharmaceuticals is …
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Michael F. Roizen, MD to Increase Activities with Telomir Pharmaceuticals as Special Advisor on Age Reversal
05 Mar 2024 13:30 GMT
… as it pursues potential treatments aimed at extending … patents, including RELISTOR® (methylnaltrexone bromide), a drug he co- … line. About Telomir Pharmaceuticals, Inc. Telomir Pharmaceuticals, Inc. is … and potential clinical trials and the potential …
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Salix Pharmaceuticals Announces a Phase 2 Investigator-Initiated Study of RELISTOR(R) (methylnaltrexone bromide: MNTX) in Patients with Resectable Head and Neck Squamous Cell Carcinoma
06 Mar 2024 13:51 GMT
… ) and its gastroenterology business, Salix Pharmaceuticals, today announced that it is … investigator-initiated study (IIS) of RELISTOR® (methylnaltrexone bromide: MNTX) in patients … MD Anderson Cancer Center. The trial is designed to evaluate the …
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Human medicines European public assessment report (EPAR): Relistor, methylnaltrexone bromide, Date of authorisation: 01/07/2008, Revision: 19, Status: Authorised
05 Dec 2023 14:35 GMT
… addition to the usual laxative medicines. The dose depends on the … ; treatment with usual laxatives should be stopped when starting Relistor. Relistor is usually injected … blood clearance technique).
Patients can inject Relistor themselves once they have been …
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Lantheus Announces Agreement to Sell RELISTOR® Royalties to HealthCare Royalty
03 Aug 2023 11:10 GMT
… diluted earnings per share. Progenics Pharmaceuticals, Inc., a Lantheus company … Tablet and Subcutaneous injection RELISTOR® products to Salix Pharmaceuticals, Inc., a … antagonist. RELISTOR tablets and RELISTOR injection are indicated for the treatment of …
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Methylnaltrexone Treatment for Opioid-Induced Constipation in Patients with and without Cancer: Effect of Initial Dose
27 Jul 2023 07:53 GMT
… eg, physiologic dysfunction, concomitant medications, dehydration, immobility, diet, … placebo-controlled trials of MNTX treatment for patients with … to receive SC injections of 8 mg … 09.158.
15. Salix Pharmaceuticals. Relistor [Package Insert]. Bridgewater, …
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3 Medical Research Stocks to Buy This Week
27 Jun 2023 20:58 GMT
… to pharmaceutical and biotechnology companies outsourcing … to help doctors, hospitals, pharmaceutical companies, … AZEDRA, Neurolite, RELISTOR, PYLARIFY AI, etc … Drug Administration (FDA) had granted Fast Track designation for 177Lu-PNT2002, a treatment …
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New Drug Names: A Study In Madness
31 Jan 2023 15:22 GMT
… ad for RELISTOR®, a drug for opioid- … pills) is "a pyruvate kinase activator indicated for the treatment … (antiviral)
Reboxetine (antidepressant)
Zaleplon (sleeping pill)
Tamsulosin (increases … up with them, pharmaceutical companies employ teams …
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Subcutaneous Methylnaltrexone as Treatment for Opioid-Induced Constipation in Patients with Advanced Cancer and Noncancer Illnesses: A Post Hoc Analysis of Two Clinical Trials
09 Feb 2023 14:22 GMT
… chronic noncancer pain. Injectable methylnaltrexone dosing is … randomized, placebo-controlled trials of SC methylnaltrexone … of study drug recognizing that opioid treatment (and … develop and commercialize Relistor® from Progenics Pharmaceuticals, Inc., New …
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