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Wen 〡 Ke Zhi Kang
According to the author's statistics, the FDA approved 17 NDA/BLA applications from January to February 2021.
1 biological medicine:
1 biological medicine:?? Evkeeza: an ANGPTL3 (angiopoietin-like 3) inhibitor, as an adjuvant drug for other low-density lipoprotein cholesterol (LDL-C) lowering therapies, for the treatment of homozygous familial hypercholesterolemia of 12 years and older (HoFH) adult and pediatric patients.
1 cell and gene therapy:
1 cell and gene therapy:?? Breyanzi: The treatment does not respond to at least two other types of systemic treatments, or adult patients with large B-cell lymphoma that recur after treatment.
10 new molecular entities (Type 1):
10 new molecular entities (Type 1):?? Verquvo: a soluble guanylate cyclase (sGC) stimulator, used in adults with symptomatic chronic heart failure and an ejection fraction below 45% to reduce the need for hospitalization or outpatient intravenous diuresis due to heart failure Risk of cardiovascular death and heart failure hospitalization due to drug
?? Vocabria: an HIV-1 integrase chain transfer inhibitor (INSTI), combined with EDURANT (rilpivirine), used to inhibit the virus under a stable antiretroviral treatment regimen (HIV-1 RNA <50 copies /mL) for short-term treatment in adults.
?? Cabenuva Kit: a combination of two drugs packaged by HIV-1 integrase chain transfer inhibitor (INSTI) cabotegravir and HIV-1 non-nucleoside reverse transcriptase inhibitor (NNRTI) rilpivirine, which is considered to treat adult HIV- 1 A complete long-acting plan for infection, as an alternative to the current antiretroviral treatment plan.
?? Lupkynis: a calcineurin inhibitor immunosuppressant, used in combination with a background immunosuppressive treatment regimen for the treatment of adult patients with active lupus nephritis (LN).
??Tepmetko: a kinase inhibitor for the treatment of adult metastatic non-small cell lung cancer (NSCLC) with a jumping mutation in exon 14 of mesenchymal epithelial transformation (MET).
?? Ukoniq: a kinase inhibitor used to treat relapsed or refractory marginal zone lymphoma (MZL) and relapsed or refractory follicular lymphoma (FL).
?? Cosela: a CDK4/6 kinase inhibitor, used to reduce the incidence of chemotherapy-induced bone marrow suppression before patients with extensive-stage small cell lung cancer receive platinum/etoposide/topotecan regimens.
?? Amondys 45: an antisense oligonucleotide for the treatment of Duchenne muscular dystrophy (DMD) with a jump mutation in exon 45 of the DMD gene.
?? Nulibry: the first type A drug for the treatment of molybdenum cofactor deficiency.
?? Pepaxto: treatment of relapsed or refractory multiple myeloma.
2 new dosage forms (Type 3):
2 new dosage forms (Type 3):?? Pemetrexed: Pemetrexed powder injection, 505(b)(2) route was temporarily approved (patent reason).
?? Posimir: an amide local anesthetic used for arthroscopic subacromial space decompression, resulting in up to 72 hours of postoperative analgesia.
4 new formulas or new manufacturers (Type 5):
4 new formulas or new manufacturers (Type 5):?? Norepinephrine Bitartrate In 5% Dextrose: Norepinephrine tartrate is a catecholamine used for blood pressure recovery in adult patients with acute hypotension.
?? Acetaminophen: 2 acetaminophen injections, used to reduce fever and pain.
?? Pemetrexed: Pemetrexed injection, 505(b)(2) route was temporarily approved (patent reason).
Type 1 new molecular entity
Type 3 new dosage form
Type 4 new combination
Type 5 new formula or new manufacturer
