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[Pharmaceutical Network Industry News] New Drug Abbreviation Application (ANDA, US generic drug application), the application has been reviewed and approved by the US FDA, which means that the applicant can produce and sell the product in the US market
.
Since 2022, a number of domestic drug ANDAs have received good news of FDA approval, involving Huahai Pharmaceutical, Zhongsheng Pharmaceutical,
etc.
Several products of Huahai Pharmaceutical Since the beginning of this year, several products of Huahai Pharmaceutical have been approved by the FDA.
For example, on January 5, Huahai Pharmaceutical issued an announcement saying that the company has submitted a brief application for the new drug of paracetamol and hydrocodone tablets to the US FDA.
Approved for the relief of moderate to moderately severe pain
.
On April 11, Huahai Pharmaceutical announced that its ANDA application for nebivolol tablets filed with the US FDA has been approved, which is mainly used for the treatment of hypertension
.
On April 13, Huahai Pharmaceutical announced that the abbreviated new drug application (ANDA) for apixaban tablets submitted by the company to the US FDA has been provisionally approved
.
Apixaban tablets are mainly used to reduce the risk of stroke and systemic embolism
.
Huahai Pharmaceutical announced not long ago that its new drug brief application for levetiracetam injection and febuxostat tablets submitted to the US FDA has also been approved
.
Among them, levetiracetam injection is mainly used for the treatment of epilepsy
.
Febuxostat is mainly used for the long-term treatment of hyperuricemia in gout patients
.
On the evening of April 28, the company also announced that it had filed with the US FDA for an abbreviated new drug application (ANDA) for quetiapine sustained-release tablets for the treatment of schizophrenia
.
The product application was reviewed by the US FDA .
Approval means that the company has been approved to manufacture and sell in the US market
.
Colesevelam Hydrochloride Tablets In March, China Biopharmaceutical announced that the hypolipidemic drug "Colesevelam Hydrochloride Tablets" developed by the group had been approved by the US FDA for abbreviated new drug application (ANDA, or US generic drug application)
.
The announcement shows that colesevelam hydrochloride tablet is a non-absorbable polymer oral drug, used alone or in combination with any statin, can be used as an adjuvant therapy for primary hyperlipidemia diet and exercise, To reduce elevated low-density lipoprotein cholesterol (LDL-C) levels in patients; it is also used to assist diet control and exercise control to improve blood sugar control in adults with type 2 diabetes
.
It is reported that in terms of blood lipid control, colesevelam hydrochloride, as a new generation of bile acid chelator, can bind bile acid and hepatocholic acid, the main component of bile acid, in the intestine, thereby preventing the reabsorption of bile acid, and the large consumption of bile acid will promote Cholesterol is converted to bile acids
.
These compensatory effects increase the clearance of LDL-C from the blood, thereby reducing serum LDL-C levels
.
Sino Biopharmaceutical said that the approval of this product in the United States will enhance the Group's product layout in overseas international markets and bring better treatment options to the majority of hyperlipidemia patients
.
On April 14, Hengrui Medicine announced that the abbreviated new drug application for gadoteric acid meglumine injection submitted by the company to the US FDA has been approved
.
It is reported that gadoteric acid meglumine injection is a gadolinium-based intravenous contrast agent for MRI of the brain (intracranial), spine and related tissues in adults and children (including neonates) to check for blood-brain barrier damage and Vascular abnormalities
.
Ibuprofen tablets Renfu Pharmaceutical announced in early April that recently, Yichang Renfu, a subsidiary of the company, received the FDA approval number for ibuprofen tablets, and the product ANDA was approved by the FDA
.
This medicine is indicated for the relief of mild to moderate pain such as headache, joint pain, migraine, toothache, muscle pain, neuralgia, dysmenorrhea, and also for fever caused by the common cold or influenza
.
Disclaimer: Under no circumstances does the information or opinions expressed in this article constitute investment advice to anyone
.
.
Since 2022, a number of domestic drug ANDAs have received good news of FDA approval, involving Huahai Pharmaceutical, Zhongsheng Pharmaceutical,
etc.
Several products of Huahai Pharmaceutical Since the beginning of this year, several products of Huahai Pharmaceutical have been approved by the FDA.
For example, on January 5, Huahai Pharmaceutical issued an announcement saying that the company has submitted a brief application for the new drug of paracetamol and hydrocodone tablets to the US FDA.
Approved for the relief of moderate to moderately severe pain
.
On April 11, Huahai Pharmaceutical announced that its ANDA application for nebivolol tablets filed with the US FDA has been approved, which is mainly used for the treatment of hypertension
.
On April 13, Huahai Pharmaceutical announced that the abbreviated new drug application (ANDA) for apixaban tablets submitted by the company to the US FDA has been provisionally approved
.
Apixaban tablets are mainly used to reduce the risk of stroke and systemic embolism
.
Huahai Pharmaceutical announced not long ago that its new drug brief application for levetiracetam injection and febuxostat tablets submitted to the US FDA has also been approved
.
Among them, levetiracetam injection is mainly used for the treatment of epilepsy
.
Febuxostat is mainly used for the long-term treatment of hyperuricemia in gout patients
.
On the evening of April 28, the company also announced that it had filed with the US FDA for an abbreviated new drug application (ANDA) for quetiapine sustained-release tablets for the treatment of schizophrenia
.
The product application was reviewed by the US FDA .
Approval means that the company has been approved to manufacture and sell in the US market
.
Colesevelam Hydrochloride Tablets In March, China Biopharmaceutical announced that the hypolipidemic drug "Colesevelam Hydrochloride Tablets" developed by the group had been approved by the US FDA for abbreviated new drug application (ANDA, or US generic drug application)
.
The announcement shows that colesevelam hydrochloride tablet is a non-absorbable polymer oral drug, used alone or in combination with any statin, can be used as an adjuvant therapy for primary hyperlipidemia diet and exercise, To reduce elevated low-density lipoprotein cholesterol (LDL-C) levels in patients; it is also used to assist diet control and exercise control to improve blood sugar control in adults with type 2 diabetes
.
It is reported that in terms of blood lipid control, colesevelam hydrochloride, as a new generation of bile acid chelator, can bind bile acid and hepatocholic acid, the main component of bile acid, in the intestine, thereby preventing the reabsorption of bile acid, and the large consumption of bile acid will promote Cholesterol is converted to bile acids
.
These compensatory effects increase the clearance of LDL-C from the blood, thereby reducing serum LDL-C levels
.
Sino Biopharmaceutical said that the approval of this product in the United States will enhance the Group's product layout in overseas international markets and bring better treatment options to the majority of hyperlipidemia patients
.
On April 14, Hengrui Medicine announced that the abbreviated new drug application for gadoteric acid meglumine injection submitted by the company to the US FDA has been approved
.
It is reported that gadoteric acid meglumine injection is a gadolinium-based intravenous contrast agent for MRI of the brain (intracranial), spine and related tissues in adults and children (including neonates) to check for blood-brain barrier damage and Vascular abnormalities
.
Ibuprofen tablets Renfu Pharmaceutical announced in early April that recently, Yichang Renfu, a subsidiary of the company, received the FDA approval number for ibuprofen tablets, and the product ANDA was approved by the FDA
.
This medicine is indicated for the relief of mild to moderate pain such as headache, joint pain, migraine, toothache, muscle pain, neuralgia, dysmenorrhea, and also for fever caused by the common cold or influenza
.
Disclaimer: Under no circumstances does the information or opinions expressed in this article constitute investment advice to anyone
.