Memorytamer 1 5 1 – Automatic Memory Freeing Approved

• Memorytamer 1 5 1 – Automatic Memory Freeing Approved Items
• Memorytamer 1 5 1 – Automatic Memory Freeing Approved Devices

Wise Memory Optimizer automatically calculates and displays the used, free and total memory of your computer upon deployment, along with a pie chart. You can learn your PC memory usage at a glance. Single click the 'Optimize Now' button, the program can free up memory in several seconds. Memory overclocking has a significant impact on performance of AMD Ryzen-powered machines, but the alleged complexity of memory tweaking on this platform, largely fueled by misinformation and lack of documentation, has kept some enthusiasts away from it. We want to change this.

The following drugs have recently been approved by the FDA. Includes newly approved drugs and new indications for drugs already approved.

See also: Generic Approvals, Approval Process, New Indications and Dosage forms

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• New Drugs

Veklury (remdesivir) Injection

Company:Gilead Sciences, Inc.
Date of Approval: October 22, 2020
Treatment for:COVID-19

Veklury (remdesivir) is a SARS-CoV-2 nucleotide analog RNA polymerase inhibitor indicated for the treatment of COVID-19 patients who require hospitalization.

• FDA Approves Veklury (remdesivir) for the Treatment of COVID-19 - October 22, 2020

Inmazeb (atoltivimab, maftivimab, and odesivimab-ebgn) Injection

Company:Regeneron Pharmaceuticals, Inc.
Date of Approval: October 14, 2020
Treatment for:Zaire Ebolavirus Infection

Inmazeb is (atoltivimab, maftivimab, and odesivimab) is a monoclonal antibody combination indicated for the treatment of Zaire ebolavirus infection in adults and children, including newborns of mothers who have tested positive for the virus.

• FDA Approves Inmazeb (atoltivimab, maftivimab and odesivimab-ebgn) Antibody Cocktail for Ebola (Zaire Ebolavirus) - October 14, 2020

Alkindi Sprinkle (hydrocortisone) Oral Granules

Company: Eton Pharmaceuticals, Inc.
Date of Approval: September 29, 2020
Treatment for: Adrenocortical Insufficiency

Alkindi Sprinkle (hydrocortisone granules in capsules for opening) is an immediate-release pediatric formulation of the approved glucocorticoid hydrocortisone for the treatment of adrenocortical insufficiency in infants, children and adolescents. Name mangler 3 6 torrent.

• FDA Approves Alkindi Sprinkle (hydrocortisone oral granules) for Pediatric Adrenocortical Insufficiency - September 30, 2020

Gavreto (pralsetinib) Capsules

Company:Genentech, Inc.
Date of Approval: September 4, 2020
Treatment for: Non-Small Cell Lung Cancer

Gavreto (pralsetinib) is an oral selective RET kinase inhibitor for the treatment of adult patients with metastatic rearranged during transfection (RET) fusion- positive non-small cell lung cancer (NSCLC) as detected by an FDA approved test.

• FDA Approves Gavreto (pralsetinib) for the Treatment of Adults With Metastatic RET Fusion-Positive Non-Small Cell Lung Cancer - September 4, 2020

Detectnet (copper Cu 64 dotatate) Injection

Company: RadioMedix Inc.
Date of Approval: September 3, 2020
Treatment for: Positron Emission Tomography Imaging

Detectnet (copper Cu 64 dotatate) is a radioactive diagnostic agent indicated for use with positron emission tomography (PET) for localization of somatostatin receptor positive neuroendocrine tumors (NETs) in adult patients.

• FDA Approves Detectnet (copper Cu 64 dotatate injection) Positron Emission Tomography (PET) Agent - September 8, 2020

Onureg (azacitidine) Tablets

Company:Bristol-Myers Squibb Company
Date of Approval: September 1, 2020
Treatment for: Acute Myeloid Leukemia

Onureg (azacitidine) is a nucleoside metabolic inhibitor indicated for the continued treatment of adult patients with acute myeloid leukemia.

• FDA Approves Onureg (azacitidine tablets) as Continued Treatment for Adults in First Remission with Acute Myeloid Leukemia - September 1, 2020

Qdolo (tramadol hydrochloride) Oral Solution

Company: Athena Bioscience, LLC
Date of Approval: September 1, 2020
Treatment for: Pain

Qdolo (tramadol hydrochloride) is an opioid agonist indicated in adults for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.

• FDA Approves Qdolo (tramadol hydrochloride) Oral Solution for the Management of Severe Pain - September 8, 2020

Xaracoll (bupivacaine hydrochloride) Implant

Company: Innocoll Holdings Limited
Date of Approval: August 28, 2020
Treatment for: Postsurgical Pain Relief Following Open Inguinal Hernia

Xaracoll (bupivacaine hydrochloride) is a fully bioresorbable collagen implant containing the local anesthetic bupivacaine indicated for acute postsurgical pain relief for up to 24 hours in adults following open inguinal hernia repair.

• FDA Approves Xaracoll (bupivacaine hydrochloride) Implant for Acute Postsurgical Pain Relief Following Open Inguinal Hernia Repair - August 31, 2020

Sogroya (somapacitan-beco) Injection

Company:Novo Nordisk
Date of Approval: August 28, 2020
Treatment for: Adult Human Growth Hormone Deficiency

Sogroya (somapacitan-beco) is a human growth hormone analog indicated for the replacement of endogenous growth hormone in adults with growth hormone deficiency.

• FDA Approves Sogroya (somapacitan-beco) a Once-Weekly Treatment for Adult Growth Hormone Deficiency - August 28, 2020

Winlevi (clascoterone) Cream

Company: Cassiopea SpA
Date of Approval: August 26, 2020
Treatment for: Acne

Winlevi (clascoterone) cream is a first-in-class topical androgen receptor inhibitor indicated for the topical treatment of acne vulgaris in patients 12 years of age and older.

• FDA Approves Winlevi (clascoterone) Cream for the Treatment of Acne - August 27, 2020

Kesimpta (ofatumumab) Injection

Company:Novartis Pharmaceuticals Corporation
Date of Approval: August 20, 2020
Treatment for: Multiple Sclerosis

Kesimpta (ofatumumab) is a CD20-directed cytolytic antibody indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.

• FDA Approves Kesimpta (ofatumumab) Targeted B-cell Therapy for Patients with Relapsing Multiple Sclerosis - August 20, 2020

Cystadrops (cysteamine hydrochloride) Ophthalmic Solution

Company: Recordati Rare Diseases Inc.
Date of Approval: August 19, 2020
Treatment for: Corneal Cystine Crystal Accumulation

Cystadrops (cysteamine hydrochloride) is a cystine-depleting agent indicated for the treatment of corneal cystine crystal deposits in adults and children with cystinosis.

• FDA Approves Cystadrops (cysteamine) Ophthalmic Solution for the Ocular Manifestations of Cystinosis - August 26, 2020

Enspryng (satralizumab-mwge) Injection

Company:Genentech, Inc.
Date of Approval: August 14, 2020
Treatment for: Neuromyelitis Optica Spectrum Disorder

Enspryng (satralizumab-mwge) is an interleukin-6 (IL-6) receptor antagonist indicated for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive.

• FDA Approves Enspryng (satralizumab-mwge) for Neuromyelitis Optica Spectrum Disorder - August 14, 2020

Viltepso (viltolarsen) Injection

Memorytamer 1 5 1 – Automatic Memory Freeing Approved Items

Company: NS Pharma, Inc.
Date of Approval: August 12, 2020
Treatment for: Duchenne Muscular Dystrophy

Viltepso (viltolarsen) is an antisense oliogonucleotide indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients who have a confirmed mutation of the DMD gene that is amenable to exon 53 skipping.

• FDA Approves Viltepso (viltolarsen) for the Treatment of Duchenne Muscular Dystrophy in Patients Amenable to Exon 53 Skipping Therapy - August 12, 2020

Evrysdi (risdiplam) for Oral Solution

Company:Genentech, Inc.
Date of Approval: August 7, 2020
Treatment for: Spinal Muscular Atrophy

Evrysdi (risdiplam) is a survival of motor neuron 2 (SMN2) splicing modifier indicated for the treatment of spinal muscular atrophy (SMA) in patients 2 months of age and older.

• FDA Approves Evrysdi (risdiplam) for Treatment of Spinal Muscular Atrophy (SMA) in Adults and Children 2 Months and Older - August 7, 2020

Olinvyk (oliceridine) Injection - formerly Olinvo

Company: Trevena, Inc.
Date of Approval: August 7, 2020
Treatment for: Pain

Olinvyk (oliceridine) is an opioid agonist for the management of moderate to severe acute pain in adults.

• FDA Approves Olinvyk (oliceridine) Injection for the Management of Severe Acute Pain - August 10, 2020

Memorytamer 1 5 1 – Automatic Memory Freeing Approved Devices

Lampit (nifurtimox) Tablets

Company:Bayer HealthCare Pharmaceuticals Inc.
Date of Approval: August 6, 2020
Treatment for: Chagas Disease

Lampit (nifurtimox) is a nitrofuran antiprotozoal used for the treatment of Chagas disease (American Trypanosomiasis) in pediatric patients.

• FDA Approves Lampit (nifurtimox) for the Treatment of Chagas Disease in Children - August 7, 2020

Blenrep (belantamab mafodotin-blmf) Injection

Company:GlaxoSmithKline
Date of Approval: August 5, 2020
Treatment for: Multiple Myeloma

Blenrep (belantamab mafodotin-blmf) is a B-cell maturation antigen (BCMA)-directed antibody and microtubule inhibitor conjugate indicated for the treatment of adult patients with relapsed or refractory multiple myeloma.

• FDA Approves Blenrep (belantamab mafodotin-blmf) for the Treatment of Patients with Relapsed or Refractory Multiple Myeloma - August 5, 2020

Monjuvi (tafasitamab-cxix) for Injection

Company: MorphoSys AG
Date of Approval: July 31, 2020
Treatment for: Diffuse Large B-Cell Lymphoma

Monjuvi (tafasitamab-cxix) is a CD19-directed cytolytic antibody indicated in combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL).

• FDA Approves Monjuvi (tafasitamab-cxix) in Combination with Lenalidomide for the Treatment of Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL) - August 1, 2020

Tecartus (brexucabtagene autoleucel) Suspension for Intravenous Infusion - formerly KTE-X19

Company: Kite, a Gilead Company
Date of Approval: July 24, 2020
Treatment for: Mantle Cell Lymphoma

Tecartus (brexucabtagene autoleucel) is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL).

• FDA Approves Tecartus (brexucabtagene autoleucel) as the First and Only CAR T Treatment for Relapsed or Refractory Mantle Cell Lymphoma - July 24, 2020

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This section provides background information on the automatic memory management feature of Oracle Database, and includes instructions for enabling this feature. The following topics are covered:

About Automatic Memory Management

The simplest way to manage instance memory is to allow the Oracle Database instance to automatically manage and tune it for you. To do so (on most platforms), you set only a target memory size initialization parameter (MEMORY_TARGET) and optionally a maximum memory size initialization parameter (MEMORY_MAX_TARGET). The instance then tunes to the target memory size, redistributing memory as needed between the system global area (SGA) and the instance program global area (instance PGA). Because the target memory initialization parameter is dynamic, you can change the target memory size at any time without restarting the database. The maximum memory size serves as an upper limit so that you cannot accidentally set the target memory size too high, and so that enough memory is set aside for the Oracle Database instance in case you do want to increase total instance memory in the future. Because certain SGA components either cannot easily shrink or must remain at a minimum size, the instance also prevents you from setting the target memory size too low.

If you create your database with Database Configuration Assistant (DBCA) and choose the basic installation option, automatic memory management is enabled. If you choose advanced installation, Database Configuration Assistant (DBCA) enables you to select automatic memory management.

Note:

See Also:

Enabling Automatic Memory Management

If you did not enable automatic memory management upon database creation (either by selecting the proper options in DBCA or by setting the appropriate initialization parameters for the CREATE DATABASE SQL statement), you can enable it at a later time. Enabling automatic memory management involves a shutdown and restart of the database.

To enable automatic memory management

1. Start SQL*Plus and connect to the database as SYSDBA.

   See 'About Database Administrator Security and Privileges' and 'Database Administrator Authentication' for instructions.

2. Calculate the minimum value for MEMORY_TARGET as follows:

   1. Microsoft office programs. Determine the current sizes of SGA_TARGET and PGA_AGGREGATE_TARGET by entering the following SQL*Plus command:

      SQL*Plus displays the values of all initialization parameters with the string TARGET in the parameter name.

   2. Run the following query to determine the maximum instance PGA allocated since the database was started:

   3. Compute the maximum value between the query result from step 2b and PGA_AGGREGATE_TARGET. Add SGA_TARGET to this value.

   For example, if SGA_TARGET is 272M and PGA_AGGREGATE_TARGET is 90M as shown above, and if the maximum PGA allocated is determined to be 120M, then MEMORY_TARGET should be at least 392M (272M + 120M).

3. Choose the value for MEMORY_TARGET that you want to use.

   This can be the minimum value that you computed in step 2, or you can choose to use a larger value if you have enough physical memory available.

4. For the MEMORY_MAX_TARGET initialization parameter, decide on a maximum amount of memory that you would want to allocate to the database for the foreseeable future. That is, determine the maximum value for the sum of the SGA and instance PGA sizes. This number can be larger than or the same as the MEMORY_TARGET value that you chose in the previous step.

5. Do one of the following:

   • If you started your Oracle Database instance with a server parameter file, which is the default if you created the database with the Database Configuration Assistant (DBCA), enter the following command:

     where n is the value that you computed in Step 4.

     The SCOPE=SPFILE clause sets the value only in the server parameter file, and not for the running instance. You must include this SCOPE clause because MEMORY_MAX_TARGET is not a dynamic initialization parameter.

   • If you started your instance with a text initialization parameter file, manually edit the file so that it contains the following statements:

     where n is the value that you determined in Step 4, and m is the value that you determined in step 3.

   Note:

   In a text initialization parameter file, if you omit the line for MEMORY_MAX_TARGET and include a value for MEMORY_TARGET, the database automatically sets MEMORY_MAX_TARGET to the value of MEMORY_TARGET. If you omit the line for MEMORY_TARGET and include a value for MEMORY_MAX_TARGET, the MEMORY_TARGET parameter defaults to zero. After startup, you can then dynamically change MEMORY_TARGET to a nonzero value, provided that it does not exceed the value of MEMORY_MAX_TARGET.

6. Shut down and restart the database.

   See Chapter 3, 'Starting Up and Shutting Down' for instructions.

7. If you started your Oracle Database instance with a server parameter file, enter the following commands:

   where n is the value that you determined in step 3.

Note:

See Also:

• Oracle Database SQL Language Reference for information on the ALTERSYSTEM SQL statement

Monitoring and Tuning Automatic Memory Management

The dynamic performance view V$MEMORY_DYNAMIC_COMPONENTS shows the current sizes of all dynamically tuned memory components, including the total sizes of the SGA and instance PGA.

The view V$MEMORY_TARGET_ADVICE provides tuning advice for the MEMORY_TARGET initialization parameter.

The row with the MEMORY_SIZE_FACTOR of 1 shows the current size of memory, as set by the MEMORY_TARGET initialization parameter, and the amount of DB time required to complete the current workload. In previous and subsequent rows, the results show a number of alternative MEMORY_TARGET sizes. For each alternative size, the database shows the size factor (the multiple of the current size), and the estimated DB time to complete the current workload if the MEMORY_TARGET parameter were changed to the alternative size. Notice that for a total memory size smaller than the current MEMORY_TARGET size, estimated DB time increases. Notice also that in this example, there is nothing to be gained by increasing total memory size beyond 450MB. However, this situation might change if a complete workload has not yet been run.

Enterprise Manager provides an easy-to-use graphical memory advisor to help you select an optimal size for MEMORY_TARGET. See Oracle Database 2 Day DBA for details.

See Also:

• Oracle Database Reference for more information about these dynamic performance views

• Oracle Database Performance Tuning Guide for a definition of DB time.