Accessdata.fda.gov

[email protected]: FDA-Approved Drugs

* [email protected] includes information about drugs, including biological products, approved for human use in the United States (see FAQ), but does not include information about FDA-approved products regulated by the Center for Biologics Evaluation and Research (for example, vaccines, allergenic products, blood and blood products, plasma derivatives, cellular and gene therapy products).

Actived: 7 days ago

URL: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=medguide.page

MEDICATION GUIDE

(4 days ago) • VIVITROL is a prescription injectable medicine used to treat alcohol dependence in adults 18 years and older. • You should stop drinking before starting VIVITROL. • To be effective, treatment with VIVITROL must be used along with other alcoholism recovery programs such as counseling. VIVITROL may not work for everyone.

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FoundationFocus CDxBRCA Technical Information Summary

(9 days ago) The Foundation Medicine BRCAFoundationFocus CDx assay is a companion diagnostic to Clovis Oncology’s drug Rubraca, a poly (ADP-ribose) polymerase (PARP) inhibitor. Specimens that are found to have a deleterious BRCA alteration in their tumor tissue (tBRCA+) may be eligible for treatment with Rubraca therapy. Test Kit Contents

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FoundationOne Liquid CDx Technical Information

(9 days ago) Medicine, Inc. • Genomic findings from circulating cell-free DNA (cfDNA) may originate from circulating tumor DNA fragments, germline alterations, or nontumor somatic alterations, such as clonal hematopoiesis of indeterminate potential (CHIP). Genes with alterations that may be derived from CHIP include, but are not limited to, the following:

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SUMMARY OF SAFETY AND EFFECTIVENESS DATA …

(9 days ago) for treatment with Rubraca. This assay is to be performed at Foundation Medicine, Inc., a single laboratory site located at 150 Second Street, Cambridge, MA 02141. III. CONTRAINDICATIONS. There are no known contraindications . IV. WARNINGS AND PRECAUTIONS. The warnings and precautions can be found in the FoundationFocus CDx BRCA assay labeling.

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SUMMARY OF SAFETY AND EFFECTIVENESS DATA …

(3 days ago) CDx (F1CDx) is a single-site assay performed at Foundation Medicine, Inc. The assay includes reagents, software, instruments and procedures for testing DNA extracted from formalin-fixed, paraffin-embedded (FFPE) tumor samples.

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510(k) Summary GMPlWireless Medicine LifeSyncTM System

(7 days ago) The GMPl Wireless Medicine LifeSyncTM System is substantially equivalent to the Mortara Ambulatory X-12 Telemetry Module that was cleared by FDA under K974149 on January 8, 1998. B. DEVICE DESCRIPTION The GMPl Wireless Medicine LifeSyncTM System is comprised of 4 primary components and 1 accessory component: 1) a patient wearable 5-electrode array

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Food and Drug Administration

(9 days ago) National Drug Code Directory. Background Information. Drug questions email: [email protected] See also: Drug Registration and Listing Instructions. National Drug Code Directory Data Files. U.S Department of Health and Human Services. Public Health Service. Food and Drug Administration. Center for Drug Evaluation and Research.

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SUMMARY OF SAFETY AND EFFECTIVENESS DATA …

(9 days ago) FoundationOne CDx (F1CDx) is a single-site assay performed at Foundation Medicine, Inc. The assay includes reagents, software, instruments and procedures for testing DNA extracted from formalin-fixed, paraffin-embedded (FFPE) tumor samples.

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Product Classification

(2 days ago) Product Classification. Daily activity assist device. A solid medication dispenser is a device intended for medical purposes that is used to issue solid (pills) medication. The device is designed for primarily oral dosage forms of medication. This device can function independently, with components or within a system. dependent on drug indication.

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Premarket Approval (PMA)

(4 days ago) If a patient is positive for any of the deleterious alterations specified in the BRCA1/2 classification, the patient may be eligible for treatment with Rubraca. This assay is to be performed at Foundation Medicine, Inc., a single laboratory site located at 150 Second Street, Cambridge, Massachusetts. Approval Order: Approval Order: Summary

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Premarket Approval (PMA)

(5 days ago) Generic Name. next generation sequencing oncology panel, somatic or germline variant detection system. Applicant. Foundation Medicine Inc. 150 second street. cambridge, MA 02141. PMA Number. P190032. Date Received.

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DRAFT FoundationFocus CDx BRCA LOH Technical Information

(3 days ago) exclusively in the Foundation Medicine laboratory. The FoundationFocus CDx BRCA LOH assay is intended to be performed with serial number-controlled instruments. Sample Collection and Test Ordering To order the FoundationFocus CDx BRCA LOH assay, the Test Requisition Form (TRF) included in the test kit must be fully completed and signed by the

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Summary of Safety and Effectivness (SSED)Template

(9 days ago) yield. Indexed (Foundation Medicine customized six base pair barcodes) sequencing libraries are PCR amplified with a high-fidelity DNA polymerase (HiFi™, Kapa) for ten cycles, SPRI purified and quantified by PicoGreen® fluorescence assay (Invitrogen). Process matched control (PMC) is …

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PERFOROMIST Medication Guide

(6 days ago) more medicine than prescribed for you, or . o. with other LABA medicines Call your healthcare provider or get emergency medical care right away if: • your breathing problems worsen with PERFOROMIST Inhalation Solution • you need to use your rescue inhaler medicine more often than usual •

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What Is an OTC Drug

(8 days ago) Let's start with the basics. What exactly is an over-the-counter (OTC) drug? There are hundreds of OTC drugs at your local pharmacy. Many items you may think are cosmetics, dietary supplements, or medical devices, which have their own regulatory requirements, may also be classified as "drugs."

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DILAUDID --- ---DOSAGE AND ADMINISTRATION --­ …

(5 days ago) 7 drug 8 use 8.1. 12.1 12.3 16 17 patient *sections or subs . full prescribing information: contents* warning: addiction, abuse, and misuse; life­

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W.O.M. World of Medicine GmbH Head of Regulatory Affairs

(8 days ago) W.O.M. WORLD OF MEDICINE GmbH Salufer 8 10587 Berlin Germany 3001556604 Contact Person: Dr. Soeren Markworth Head of Regulatory Affairs Phone: +4930-399 81-594 Fax: +4930-399 81-593 E-mail: [email protected] Date prepared: 6th of April, 2018 2. Proposed Device Trade Name: ARTHRO-Pump PA304 Common Name: Pump for Arthroscopy

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INHALATION INHALATION SYSTEM Instructions for use …

(8 days ago) Obtain one medicine cup and inspect it for any holes, cracks, or dents. Do not use the medicine cup if it is damaged. Insert the empty medicine cup into the chamber of the device, making sure that the cup’s bottom tip is in the distilled water. 1 2 45 mL distilled water Sensor (inside chamber) 6 Filling CAUTION Make sure you insert only one

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FoundationOne CDx Intended Use Table 1

(3 days ago) Page 1 of 45 RAL-0003-03. FoundationOne®CDx . Technical Information . Foundation Medicine, Inc. 150 Second Street, Cambridge, MA 02141 . Phone: 617.418.2200 . Intended Use . FoundationOne®CDx (F1CDx) is a next generation sequencing based in vitro diagnostic device for detection of substitutions, insertion and deletion alterations (indels), and copy number alterations (CNAs) in 324 genes and

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MEDICATION GUIDE (zoledronic acid) Injection What is the

(6 days ago) Reclast is a prescription medicine used to: • Treat or prevent osteoporosis in women after menopause. Reclast helps reduce the chance of having a hip or spinal fracture (break). • Increase bone mass in men with osteoporosis. • Treat or prevent osteoporosis in either men or women who will be taking corticosteroid medicines for at least one

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SUMMARY OF SAFETY & EFFECTIVENESS Submitter: W.O.M. …

(8 days ago) WORLD OF MEDICINE Aquilex Fluid Control System HI 12 Special 5 10(k) Premarket Notification diagnostic and operative hysteroscopy (Karl Storz Hamou Endomat), and to monitor the volume differential between the irrigation fluid flowing into and out of the uterus (TUR Fluid Management System and Flo-Stat Fluid Monitoring System).

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Medication Guide Oral Transmucosal Fentanyl Citrate (OTFC)

(6 days ago) • OTFC is a prescription medicine that contains the medicine fentanyl. OTFC is a federally controlled substance (CII) because it is a strong opioid pain medicine that can be abused by people who abuse prescription medicines or street drugs. OTFC is to be used only to treat breakthrough pain in adult patients with cancer (16 years

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INFeD (IRON DEXTRAN INJECTION USP) Rx only Revised

(5 days ago) INFeD ® (IRON DEXTRAN INJECTION USP) Rx only Revised: September 2020 WARNING: RISK FOR ANAPHYLACTIC-TYPE REACTIONS Anaphylactic-type reactions, including fatalities, have followed the parenteral administration of iron

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Premarket Approval (PMA)

(5 days ago) Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes.

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Import Alert 66-10

(8 days ago) Chinese Herbal Medicines. When accompanied by drug claims, charge: "The article is subject to refusal of admission pursuant to 801(a)(3) in that it appears the labeling fails to bear adequate directions for use for its intended purposes [Misbranded, 502(f)(1)].- OASIS Charge Code - DIRECTIONS and -it appears to be a new dug without an effective new drug application [Unapproved new drug, …

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MEDICATION GUIDE SUBUTEX (Sub-u-tex) (buprenorphine

(8 days ago) • SUBUTEX is a prescription medicine used to begin treatment in adults who are addicted to (dependent on) opioid drugs (either prescription or illegal drugs), as part of a complete treatment program that also includes counseling and behavioral therapy.

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Instructions for Use Repatha Single-Use Prefilled

(5 days ago) Orange cap on Window Medicine . Step 1: Prepare 1A Remove 1 Repatha SureClick autoinjector from the package. Carefully lift the autoinjector straight up out of the box. Put the original package with any unused autoinjectors back in the refrigerator. Wait at least 30 minutes for the autoinjector to reach room temperature before injecting.

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Medication Guide DULERA 200 mcg/5 mcg

(5 days ago) DULERA combines an inhaled corticosteroid medicine, mometasone furoate (the same medicine found in . ASMANEX TWISTHALER), and a long-acting beta. 2-agonist medicine (LABA), formoterol (the same medicine found in FORADIL ® AEROLIZER ®). • Inhaled corticosteroids help to decrease inflammation in the lungs. Inflammation in the lungs can lead to

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HIGHLIGHTS OF PRESCRIBING INFORMATION Do not use in

(Just Now) Do not use in combination with an additional medicine containing a LABA because of risk of overdose. (5.3) If paradoxical bronchospasm occurs, discontinue ANORO ELLIPTA and institute alternative therapy. (5.5) Use with caution in patients with cardiovascular disorders because of …

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TORADOL ORAL (ketorolac tromethamine tablets) Rx

(5 days ago) 1 TORADOL ORAL (ketorolac tromethamine tablets) Rx only WARNING TORADOLORAL (ketorolac tromethamine), a nonsteroidal anti-inflammatory drug (NSAID), is indicated for the short-term (up to 5 days in adults), management of moderately severe acute pain that requires analgesia at …

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Rx only Instructions for Use TheraSphere™ Yttrium-90 Glass

(9 days ago) K120615-081 2 Rev. 1 (03/2021) 1 2 DEVICE DESCRIPTION . The TheraSphere Yttrium-90 (Y-90) Glass Microsphere System consists of: • a sterile, single use, dose vial of TheraSphere,Y-90 Glass Microspheres,available in 3 GBq – 20 GBq

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Tussionex Pennkinetic (hydrocodone polistirex and

(5 days ago) Tussionex ® Pennkinetic ® (hydrocodone polistirex and chlorpheniramine polistirex) Extended-Release Suspension CII. Rx only . DESCRIPTION . Each 5 mL of TUSSIONEX Pennkinetic ExtendedRelease Suspension contains hydrocodone -

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DELESTROGEN® (estradiol valerate injection, USP)

(5 days ago) DELESTROGEN® (estradiol valerate injection, USP) Prescribing Information as of November 2017 3001078H ESTROGENS INCREASE THE RISK OF ENDOMETRIAL CANCER

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Class 2 Device Recall CenturionMedicine Cup

(4 days ago) Centurion-Medicine Cup GMC205 GLASS MEDICINE CUP 2 OUNCE STERILE Code Information: Product-Lot Code: GMC205 GLASS MEDICINE CUP 2 OUNCE STERILE 2019022590 : Recalling Firm/ Manufacturer: Centurion Medical Products Corporation 100 Centurion Way Williamston MI 48895-9086: For Additional Information Contact: SAME 517-546-5400 Manufacturer Reason

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ZIAC (Bisoprolol Fumarate and Hydrochlorothiazide) Tablets

(5 days ago) 19 ng/mL and 36 ng/mL occur approximately 3 hours after the administration of the 2.5 mg/6.25 mg, 5 mg/6.25 mg and 10 mg/6.25 mg combination tablets, respectively.

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Class 2 Device Recall NM/CT 870 DR

(4 days ago) The system output can also be used by the physician for staging and restaging of tumors, planning, guiding, and monitoring therapy. The GE Discovery NM/CT 670 system, combining Nuclear Medicine (NM) and Computed Tomography (CT) systems, is intended to produce: Code Information

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HIGHLIGHTS OF PRESCRIBING INFORMATION thereafter or as

(5 days ago) antidiarrheal medicine (e.g., loperamide) or anti-emetics. Discontinue OFEV if severe diarrhea, nausea, or vomiting persists despite symptomatic treatment. (5.3) Embryo-Fetal toxicity: Can cause fetal harm. Advise females of reproductive potential of the potential risk to …

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Foundation Medicine, Inc. Re: P170019/S015 Trade/Device

(3 days ago) the device are restricted to Foundation Medicine, Inc. at 150 Second Street, Cambridge, Massachusetts 02141 and 7010 Kit Creek Rd., Morrisville, NC 27560. FDA. FDA has determined that these restrictions on sale and distribution are necessary to provide reasonable …

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Class 2 Device Recall Mueller Sports Medicine Hybrid

(4 days ago) Mueller Sports Medicine, Inc. 1 Quench Dr. Prairie Du Sac WI 53578-2100. For Additional Information Contact. 800-356-9522. Manufacturer Reason. for Recall. Natural rubber is present in Hybrid Wraparound Knee Support labeled as "Not made with Natural Rubber latex". FDA Determined.

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Instructions for Use Prefilled Syringe

(5 days ago) used prefilled syringe away (See Step 3) after one dose, even if there is medicine left in it. Do not reuse your SIMPONI prefilled syringe. If your healthcare provider decides that you or a caregiver may be able to give your injections of SIMPONI at home, you should receive training on the right way to

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Motrin® Ibuprofen Tablets, USP

(5 days ago) Effective Date: 01/20/2007 Motrin® Ibuprofen Tablets, USP Cardiovascular Risk • NSAIDs may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be …

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FoundationOne CDx Intended Use Table 1 Companion

(3 days ago) Page 1 of 47 RAL-0003-04. FoundationOne®CDx . Technical Information . Foundation Medicine, Inc. 150 Second Street, Cambridge, MA 02141 . Phone: 617.418.2200 . Intended Use . FoundationOne®CDx (F1CDx) is a next generation sequencing based in vitrodiagnostic device for detection of substitutions, insertion and deletion alterations (indels), and copy number alterations (CNAs) in 324 genes and

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Instructions for Opening Blister Pack

(5 days ago) n Take the medicine as soon as you open the blister pack. The tablet will dissolve in your mouth so that it can be swallowed. n Do not crush or chew. For additional safety information, please see the Full Prescribing Information and Medication Guide that come in this package and discuss with your doctor.

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Class 2 Device Recall Foundationone CDx test report

(4 days ago) Foundation Medicine, Inc. 150 2nd St Cambridge MA 02141-2115: For Additional Information Contact: Nicole Green 617-418-2200 Manufacturer Reason for Recall: Identified potential false positive MSI-H on the test reports provided to the physicians. FDA Determined Cause 2: Under Investigation by firm: Action: Firm informed the physicians via phone

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