Mumbai, Baltimore: Pharma major Lupin announced that it has received approval for its Methylprednisolone Tablets USP, 2 mg, 4 mg, 8 mg, 16 mg and 32 mg, from the United States Food and Drug Administration (FDA) to market a generic version of Pharmacia and Upjohn Company’s Medrol tablets, 2 mg, 4 mg, 8 mg, 16 mg and 32 mg.
Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA) announced today that the U.S. Food and Drug Administration has granted final approval for the Company's ANDA for Methylprednisolone Acetate Injectable Suspension, 40 mg/mL and 80 mg/mL in single dose vials.
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Value
Cited text
Known as
methylprednisolone
“including but not limited to DHAP (dexamethasone, cisplatin, high-dose cytarabine), ESHAP (etoposide, methylprednisolone, high-dose cytarabine and cisplatin), DICE...” NCT04486391 ↗911
“Intravenous methylprednisolone 1.6 mg/kg per day (given in 2 divided doses, with the maximum dose 60mg of prednisolone ) for 3 days, which is administered concurrently with the...” NCT04078568 ↗
“Oral methylprednisolone tablets (brand name: Metrol®), 20 mg once daily for 14 consecutive days; following symptom relief, the dose should be gradually reduced every 1-2 weeks...” NCT07512648 ↗
“Methylprednisolone sodium succinate for injection, United States Pharmacopeia grade (USP), sold as SOLU-MEDROL sterile powder by Pfizer, Inc, is an anti-inflammatory...” NCT04233164 ↗
“Methylprednisolone sodium succinate 80 mg powder dissolved in 100 mL of sodium chloride solution (intravenous infusion, once daily) from the day of surgery to day 3, followed...” NCT07116811 ↗
“Patients in the corticosteroid group were treated with intravenous pulsed-steroid therapy: methylprednisolone 500 mg daily intravenously for three consecutive days followed by...” NCT01621880 ↗
“Participants in this arm received postoperative analgesia with periarticular infiltration consisting of 100 mg bupivacaine, 40 mg methylprednisolone, 0.5 mg adrenaline and...” NCT07849517 ↗
“Subjects will receive the conventional steroid regimen with prednisolone or equivalent (with methylprednisolone): Day 1 to 5: 40 mg orally every 12 h; Day 6 to 10: 40 orally...” NCT03856229 ↗
“Patients will begin prednisone therapy at a dose selected by the investigator or the treating physician with oral prednisone 60mg or 1mg/kg (if weight less than 60kg) or...” NCT02169219 ↗
“high dose corticosteroid therapy (intravenous pulses of 7,5 to 15 mg/kg/day of methylprednisolone with an upper limit of 1000 mg/day for 3 days followed by oral prednisone at 1...” NCT04239196 ↗
“Chemotherapy is based upon regimes with well known effectiveness in Hodgkin lymphoma. (i.e. ABVD: doxorubicin, bleomycin, vinblastine and dacarbazine and ESHAP: Etoposide,...” NCT03500133 ↗
“The goal of this study was double, at first comparing the glycaemic profile in diabetic patients after a unique injection of 80 mg of acetate methylprednisolone either...” PMID 22185681 ↗Dec 2011
Known as
Danalone
“Methylprednisolone (Danalone) 1mg/Kg/dose twice daily for 14 days followed by 1mg/Kg/dose in the morning once daily for 14 days” NCT01614977 ↗
Known as
depo-medrol
“Epidural steroid injectate will be 2cc of 1% lidocaine followed by 1-3 cc of 40 mg/cc Kenalog (i.e. 40-120 mg Kenalog) or an equivalent steroid medication (depo-medrol 60-120...” NCT01238536 ↗40
“one injection of depo-medrol at the site of inflamed ligament attachment point (femoral condyle), combined with oral slow-acting symptomatic drugs (glucosamine 1500mg, atrodar...” NCT05971004 ↗
“Patients receiving the IA corticosteroid will be injected 3mL of 0.5% Bupivacaine and 2mL of 80mg Depo Medrol in a 10cc syringe, using an aseptic technique into the suprapatellar pouch.” NCT01923909 ↗
“Following this application, an 18-20 gauge epidural needle will be used to inject a solution containing 80 mg Depo-Medrol in 1 ml of 1% PF Lidocaine and 5ml of sterile PF saline” NCT03543033 ↗
“Prior to surgical closure, patients received 1 ml of either Depo-Medrol (DEPO) or saline (NODEPO) applied to a Gelfoam carrier at the surgical site.” PMID 29676673 ↗Apr 2018
“Participants receive 1-3 ultrasound-guided peritendinous injections of Depo-Medrol (methylprednisolone acetate 40 mg) combined with lidocaine.” NCT07650396 ↗
“Single methylprednisolone acetate intraarticular injection (DEPO-MEDROL® pfizer 80 mg) mixed with 3cc of (xylocaine 2% concentration)” NCT04980105 ↗
“Application of 40mg Depomedrol (methylprednisolone acetate) suspension into the retropharyngeal space prior to incision closure” NCT03311425 ↗
“Application of 80mg Depomedrol (methylprednisolone acetate) suspension into the transforaminal space prior to incision closure” NCT03308084 ↗
“1 ml methylprednisolon corticosteroid (40 mg Depo-Medrol®) mixed with 4 ml Lidocain (10 mg/ml) without adrenalin.” NCT01945749 ↗
“Dexamethasone 10mg or Depomedrol 40mg, together with Bupivacaine 0.25% (for 3-5mL total injectate volume)” NCT02103543 ↗
“All subjects will receive HDMP by IV infusion for up to 4 cycles (28-day cycles) as follow:
•On Cycle 1-4, Days 1 to 3, 1,000 mg/m2 Methylprednisolone will be administered.” NCT02229422 ↗2
“High dose methylprednisolone sodium succinate (HDMP) at 1gm/m2 daily as infusion for 3 consecutive days every cycle.” NCT01191190 ↗
“methylprednisolone 1000 mg/m2 (ie HDMP) on days 1-5 of cycles 1-4” NCT03113695 ↗
Known as
High Volume injection with corticosteroid
ClinicalTrials.gov intervention name — accepted as the source's own labelNCT02839577 ↗
Known as
IVMP
“OBJECTIVE: To compare intravenous methylprednisolone (IVMP) with oral prednisolone (OP) for the treatment of West syndrome.” PMID 33575989 ↗Feb 20218
“Participants randomised to the control arm will receive standard therapy of intravenous methylprednisolone (IVMP).” PMID 26009577 ↗May 2015
“Methylprednisolone(Common brand names: Medrol) or prednisone 20-40mg, qd for two weeks, then temper the dose gradually, and then 20mg qd for maintenance (The total duration of...” NCT03724903 ↗11
“Methylprednisolone will be administered once a day either in tablets; Medrol 1g per day or iv; Solumedrol 1000 mg per day, both for three consecutive days.” NCT03674099 ↗
“Patients will receive 3 mg of methylprednisolone once daily. The dose is administered in the morning (1 ½ tablets of 2 mg Medrol after breakfast).” NCT07703098 ↗
“Single injection into the glenohumeral joint under ultrasound guidance. Consists of 40 mg methylprednisolone acetate combined with 4 ml of 1% lidocaine hydrochloride. Delivered...” NCT06916650 ↗44
“Patients were infiltrated with 2 milliliters of local corticosteroid (Methyl prednisolone acetate 80mg) mixed with 1 milliliters 0.5% Bupivacaine, at the lateral epicondyle...” NCT00947765 ↗
“Group l include 50 patients who will be injected with one intra\_articular injection of 2 ml of methylprednisolone acetate 40 mg/ml mixed with 2ml of lidocaine” NCT05742061 ↗
“Control Group (corticosteroid alone) subjects will receive (40 mg/mL injection of Methylprednisolone acetate injectable suspension or 40 mg/mL triamcinolone) .” NCT03704584 ↗
“Solution to be injected will be a combination of Ropivacaine 0.2 % ( 0.5 ml/kg, maximum of 30 ml) and methylprednisolone acetate 1 mg/kg ( maximum of 40 mg ).” NCT03053401 ↗
“Intra-articular injection consisting of 80 mg of methylprednisolone acetate, 2 mL of lidocaine (1%), and 4 mL of ropivacaine (0.5%)” NCT07497737 ↗
“Application of 40mg Depomedrol (methylprednisolone acetate) suspension into the retropharyngeal space prior to incision closure” NCT03311425 ↗
“This is 40mg of a non-fluorinated injectable glucocorticoid, methylprednisolone acetate (1cc) combined with 1cc of 1% Lidocaine” NCT02044991 ↗
“Application of 80mg Depomedrol (methylprednisolone acetate) suspension into the transforaminal space prior to incision closure” NCT03308084 ↗
“Participants in the CS category were given 1 ml of 40 mg methylprednisolone acetate mixed with 2 ml of 2% prilocaine HCl.” PMID 38963583 ↗Jul 2024
“Methylprednisolone acetate (MPA)(Depomedrol) is a lipophilic glucocorticoid commonly used in chronic pain procedures.” NCT05893771 ↗
“Methylprednisolone sodium succinate for injection, United States Pharmacopeia grade (USP), sold as SOLU-MEDROL sterile powder by Pfizer, Inc, is an anti-inflammatory...” NCT04233164 ↗26
“Methylprednisolone sodium succinate is a synthetic glucocorticoid (corticosteroid) administered intravenously at a single dose of 125 mg one hour prior to the surgical...” NCT07317596 ↗
“The study determined if the administration of the corticosteroid, methylprednisolone sodium succinate, in severe ARDS that was either stable or worsening after 7 days, would...” NCT00000579 ↗
“Methylprednisolone sodium succinate can reduce the disruption of the blood-brain barrier and inflammatory response in animal models of intracerebral hemorrhage, and alleviate...” NCT06924983 ↗
“Methylprednisolone Sodium Succinate can reduce the disruption of the blood-brain barrier and inflammatory response in animal models of intracerebral hemorrhage, and alleviate...” NCT06921616 ↗
“Solumedrol, an anti-inflammatory glucocorticoid containing methylprednisolone sodium succinate, administered at 1 mg/kg as a premedication for anti-thymoglobulin (ATG)” NCT00186628 ↗
“This clinical study involves a perioperative pharmacological intervention using Methylprednisolone (Methylprednisolone Sodium Succinate for injection).” NCT07353749 ↗
“Participants were randomized 1:1 to the IV methylprednisolone sodium succinate (1000-mg) or oral prednisone (1250-mg) group.” PMID 29507942 ↗Jun 2018
“Patients will be treated with injectable methylprednisolone sodium succinate as described in Arm A.” NCT06497374 ↗
“Solu - Medrol (methylprednisolone sodium succinate) 500mg IV once single administration” NCT02798068 ↗
“methylprednisolone sodium succinate equivalent to 62.5 mg of methylprednisolone” NCT05649878 ↗
“Patients assigned to the corticosteroid group will receive (pulse) methylprednisolone succinate 500-1000 mg/day for 3 consecutive days followed by oral prednisolone (0.5...” NCT04662723 ↗4
“Evaluation of the Bioavailability of Methylprednisolone Succinate Administered Intranasally” NCT05649878 ↗
“Oral methylprednisolone tablets (brand name: Metrol®), 20 mg once daily for 14 consecutive days; following symptom relief, the dose should be gradually reduced every 1-2 weeks...” NCT07512648 ↗
Known as
metylprednisolone
“Patients enrolled in the study were given either oral amoxicillin/clavulanate (AMX/C) or metylprednisolone (MP) (group MP) or AMX/C and placebo (group P) twice daily using a...” NCT01205984 ↗
Known as
MPA
“Methylprednisolone acetate (MPA)(Depomedrol) is a lipophilic glucocorticoid commonly used in chronic pain procedures.” NCT05893771 ↗2
“dexamethasone sodium phosphate (DEX) and methylprednisolone acetate (MPA)” NCT03977454 ↗
Known as
MPD
“The AR episodes (subclinical, borderline, and Banff 1A)(26) were managed with IV methylprednisolone (MPD), 250 mg to 1 g for 3 to 5 days” NCT02328222 ↗
“Corticosteroid Injection category were given 1ml of 40 mg methylprednisolone acetate(Prednol-L 40mg,Mustafa Nevzat,Turkey) mixed with 2ml of 2% prilocaine HCl(Priloc...” NCT06236178 ↗
Known as
Solu-Medrolw
“The MP group received a single-dose of MP, 1 mg/Kg i.v. (Solu-Medrolw; Pfizer, Ballerup, Denmark)” NCT03393949 ↗
Known as
Solumedrol
“Control Group : A 22-gauge needle of venous cannula will be gently advanced in transverse direction under ultrasound guidance using the in-plane technique via ulnar side of...” NCT05053477 ↗34
“Methylprednisolone sodium succinate for injection, United States Pharmacopeia grade (USP), sold as SOLU-MEDROL sterile powder by Pfizer, Inc, is an anti-inflammatory...” NCT04233164 ↗
“Intravenous methylprednisolone (Solu-Medrol, Pharmacia Pharmaceutical Company, Belgium) 500 mg twice a day for 3 days followed by 2 weeks of oral prednisolone 1mg/kg/day...” NCT02439866 ↗
“Solumedrol, an anti-inflammatory glucocorticoid containing methylprednisolone sodium succinate, administered at 1 mg/kg as a premedication for anti-thymoglobulin (ATG)” NCT00186628 ↗
“The active study medicine is 2 x 125 mg/2 mL Solu-Medrol, a total of 250 mg/4 mL, which comes as a sterile powder with preservative free isotonic NaCl as diluent.” NCT07478003 ↗
“Methylprednisolone will be administered once a day either in tablets; Medrol 1g per day or iv; Solumedrol 1000 mg per day, both for three consecutive days.” NCT03674099 ↗
“Injection into capsular tissue after placement of the acetabular component:
0.5% Bupivacaine 15 cc 40 mg Solumedrol 10 mg Morphine 20 cc Saline” NCT02197273 ↗
“prepared by dilution of methyleprednisolone 500mg in 10 ml distilled water (Solu-Medrol, Pfizer company)” NCT04318652 ↗
“Drugs used in chemotherapy, such as etoposide, methylprednisolone, cytarabine, and cisplatin, work in different ways to stop the growth of cancer cells, either by killing the...” NCT00310128 ↗