Luoxin Pharmaceutical: 5 drugs of its subsidiaries have been approved by the U.S. FDA

On September 3, Luoxin Pharmaceutical issued an announcement stating that its subsidiary, Luoxin Anrovita, had recently obtained the approval certificate for new drug application (hereinafter referred to as "ANDA") for five drugs including levosabuterol inhalation solution issued by the FDA
.

The above-mentioned drugs are based on the "ANDA TRANSFER AGREEMENT" signed by Luoxin Anrovita and Alabindo Pharmaceutical Co.
, Ltd.
on December 31, 2019.
Alabindo Pharmaceuticals Co.
, Ltd.
transferred FDA drug registration approval documents to Luoxin Anrovita
.
On August 6, 2021, Luoxin Anrovita submitted an ANDA holder change application to the FDA and was approved recently

Basic situation of drugs

1.
Levosalbutamol inhalation solution

Drug name: Levosalbutamol inhalation solution

Dosage form: inhalation

Specification: 0.
31mg/3ml, 0.
63mg/3ml, 1.
25mg/3ml; 1.
25mg/0.
5ml

Applicant: Luoxin Anrovita Pharmaceutical (Chengdu) Co.
, Ltd.
ANDA number: 207625/207628

Levalbuterol is an adrenergic beta receptor agonist, and it is albuterol levorotatory, in which levorotatory has the effect of relaxing bronchial smooth muscle
.
It is clinically used to treat or prevent bronchospasm caused by reversible airway obstructive diseases

Levosalbutamol inhalation solution was originally developed by Sepracor Inc.
of the United States and was approved by the FDA in March 1999.
The current licensee is AKORN OPERATING, and the trade name is Xopenex
.

According to IQVIA data, the global sales of levalbuterol inhalation solution in 2020 will be 60 million U.
S.
dollars, and the sales in the United States will be 50 million U.
S.
dollars
.

2.
Ipratropium Bromide and Salbutamol Sulfate Inhalation Solution

Drug name: ipratropium bromide and salbutamol sulfate inhalation solution

Dosage form: inhalation

Specification: 0.
5mg ipratropium bromide and 3mg salbutamol sulfate/3ml

Applicant: Luoxin Anrovita Pharmaceutical (Chengdu) Co.
, Ltd.
ANDA number: 206532

Ipratropium bromide is an anticholinergic drug, which can prevent the increase of intracellular cyclo-guanylic acid phosphate caused by the interaction between acetylcholine and muscarinic receptors on bronchial smooth muscles, and has lung bronchiectasis effects
.
Salbutamol is a β 2 adrenergic receptor agonist, which acts on all smooth muscles from the main trachea to the terminal alveoli, and has an antagonistic effect on bronchoconstriction

Ipratropium Bromide and Salbutamol Sulfate Inhalation Solution was originally developed by Mylan (MYLAN SPECIALITY), and was approved by the FDA in March 2001, under the trade name DUONEB
.

According to IQVIA data, the global sales of ipratropium bromide and salbutamol sulfate inhalation solution in 2020 will be 1.
08 billion U.
S.
dollars, and the sales in the United States will be 930 million U.
S.
dollars
.

3.
Ipratropium bromide inhalation solution

Drug name: ipratropium bromide inhalation solution

Dosage form: inhalation

Specification: 0.
02% w/v

Applicant: Luoxin Anrovita Pharmaceutical (Chengdu) Co.
, Ltd.
ANDA number: 206543

Ipratropium bromide is an anticholinergic drug, which can prevent the increase of intracellular cyclo-guanylate phosphate caused by the interaction between acetylcholine and muscarinic receptors on bronchial smooth muscles, and has lung bronchiectasis effects
.
The product is used as a bronchodilator for the maintenance treatment of bronchospasm caused by chronic obstructive pulmonary diseases, including chronic bronchitis and emphysema

The ipratropium bromide inhalation solution was originally developed by Boehringer Ingelheim, and was approved by the FDA in September 1993.
The trade name is ATROVENT
.

According to IQVIA data, the global sales of ipratropium bromide inhalation solution in 2020 will be 150 million U.
S.
dollars, and the sales in the United States will be 99 million U.
S.
dollars
.

4.
Salbutamol sulfate inhalation solution

Drug name: Salbutamol sulfate inhalation solution

Dosage form: inhalation

Specification: 0.
63mg/3ml(0.
021%), 1.
25mg/3ml(0.
042%); 2.
5mg/3ml(0.
083%)

Applicant: Luoxin Anrovita Pharmaceutical (Chengdu) Co.
, Ltd.
ANDA number: 211888/206224

Salbutamol is a short-acting β 2 receptor agonist, which can selectively act on bronchial smooth muscle β 2 adrenergic receptors, and has a strong bronchial relaxation effect
.
It has a rapid clinical effect and is currently a widely used drug for the treatment of acute asthma attacks

The salbutamol sulfate inhalation solution was originally developed by GlaxoSmithKline (GSK), and was approved by the FDA in April 1992, under the trade name VENTOLIN
.

According to IQVIA data, the global sales of salbutamol inhalation solution in 2020 will be 340 million U.
S.
dollars, and the sales in the United States will be 140 million U.
S.
dollars
.

5.
Tobramycin inhalation solution

Drug name: Tobramycin inhalation solution

Dosage form: inhalation

Specification: 300mg/5ml

Applicant: Luoxin Anrovita Pharmaceutical (Chengdu) Co.
, Ltd.
ANDA number: 210871

Tobramycin is an aminoglycoside antibiotic with less clinical resistance.
It is used as a first-line treatment for early infection of Pseudomonas aeruginosa in the lungs
.
Used for repeated lung infections in patients with cystic fibrosis

Tobramycin inhalation solution was first developed by PathoGenesis (acquired by Novartis in 2001) and was approved by the FDA in December 1997 under the trade name TOBI®

According to IQVIA data, the global sales of tobramycin inhalation solution in 2020 will be 200 million U.