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AboutPricing
Drug ReportsLevomefolate
Levomefolate calcium
/ /, Beyaz, Safyral, Tydemy (levomefolate calcium) is a small molecule pharmaceutical. Levomefolate calcium was first approved as Beyaz on 2010-09-24. It is used to treat folic acid deficiency and megaloblastic anemia in the USA.
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
hemic and lymphatic diseasesD006425
nutritional and metabolic diseasesD009750
Trade Name
FDA
EMA
Combinations
Beyaz, Drospirenone, ethinyl estradiol levomefolate, Safyral, Tydemy
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Drospirenone
+
Ethinyl estradiol
+
Levomefolate calcium
Tradename
Company
Number
Date
Products
BEYAZBayerN-022532 RX2010-09-24
1 products, RLD, RS
SAFYRALBayerN-022574 RX2010-12-16
1 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
beyazNew Drug Application2023-05-19
drospirenone, ethinyl estradiol and levomefolate calcium and levomefolate calciumANDA2024-08-12
drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calciumNDA authorized generic2023-05-19
enbrace hrunapproved drug other2025-01-02
enlyteunapproved drug other2022-07-01
multi-vit-florunapproved drug other2024-04-30
paxlyteunapproved drug other2024-12-19
poly-viflorunapproved drug other2023-08-31
quflora pediatricunapproved drug other2024-01-10
quflora pediatric dropsunapproved drug other2017-08-03
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Agency Specific
FDA
EMA
No data
Patent Expiration
Patent
Expires
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FDA Information
Drospirenone / Ethinyl Estradiol / Levomefolate Calcium, Beyaz, Bayer Hlthcare
116177512030-07-17DPU-1, U-3572, U-3573, U-3574
86175972030-02-08DP
ATC Codes
No data
HCPCS
No data
Clinical
No data
Drug
General
Drug common nameLevomefolate calcium
INNlevomefolic acid
Description
Levomefolic acid (INN, also known as L-5-MTHF, L-methylfolate and L-5-methyltetrahydrofolate and (6S)-5-methyltetrahydrofolate, and (6S)-5-MTHF) is the primary biologically active form of folate used at the cellular level for DNA reproduction, the cysteine cycle and the regulation of homocysteine. It is also the form found in circulation and transported across membranes into tissues and across the blood–brain barrier. In the cell, L-methylfolate is used in the methylation of homocysteine to form methionine and tetrahydrofolate (THF). THF is the immediate acceptor of one carbon unit for the synthesis of thymidine-DNA, purines (RNA and DNA) and methionine. The un-methylated form, folic acid (vitamin B9), is a synthetic form of folate, and must undergo enzymatic reduction by dihydrofolate reductase (DHFR) to become biologically active.
Classification
Small molecule
Drug class
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
CN1c2c([nH]c(N)nc2=O)NC[C@@H]1CNc1ccc(C(=O)N[C@@H](CCC(=O)[O-])C(=O)[O-])cc1.[Ca+2]
Identifiers
PDB
CAS-ID151533-22-1
RxCUI
ChEMBL IDCHEMBL1615371
ChEBI ID
PubChem CID444412
DrugBankDBSALT001276
UNII ID8S95DH25XC (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
Revenue by drug
$
£
No data
Estimated US medical usage
Levomefolate calcium
+
Ethinyl estradiol
+
Drospirenone
+
Levomefolate
Total medical expenditures per year (USD, in millions)
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Tabular view
Trends
No data
Safety
Black-box Warning
Black-box warning for: Beyaz, Drospirenone, ethinyl estradiol and levomefolate calcium and levomefolate calcium, Drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium, Enlyte, Safyral, Select ob, Select-ob plus dha, Tydemy, Vitafol, Vitafol fe plus
Adverse Events
0 adverse events reported
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