Latest news and insights on the pharmaceutical industry | Indian Pharma Post | Page 41

Results For "United-States-Food-and-Drug-Administration"

432 News Found

Unichem receives ANDA approval for bipolar disorder drug
Drug Approval | February 28, 2022

Unichem receives ANDA approval for bipolar disorder drug

Divalproex Sodium Extended-Release tablets are indicated for the treatment of acute manic or mixed episodes associated with bipolar disorder, as monotherapy and adjunctive therapy and prophylaxis of migraine headaches


Lupin receives approval from USFDA for Arformoterol Tartrate inhalation
Drug Approval | February 08, 2022

Lupin receives approval from USFDA for Arformoterol Tartrate inhalation

Arformoterol Tartrate had estimated annual sales of US $ 251 million in the U.S. (IQVIA MAT December 2021)


Lupin receives U.S. FDA approval for Sevelamer Carbonate
Drug Approval | December 27, 2021

Lupin receives U.S. FDA approval for Sevelamer Carbonate

This product will be manufactured at Lupin's Goa facility in India


Cipla receives final approval for Lanreotide injection
Drug Approval | December 20, 2021

Cipla receives final approval for Lanreotide injection

It is indicated for the treatment of patients with acromegaly and Gastroenteropancreatic Neuroendocrine Tumours


Aragen Life Sciences acquires Intox
Biotech | December 15, 2021

Aragen Life Sciences acquires Intox

Intox is a GLP certified pre-clinical contract research organization with its test facilities in Pune


Lupin’s Goa plant receives EIR from US FDA
News | December 14, 2021

Lupin’s Goa plant receives EIR from US FDA

FDA changes inspection classification of the facility to Voluntary Action Indicated


Gland Pharma receives tentative approval for Cangrelor
Drug Approval | December 09, 2021

Gland Pharma receives tentative approval for Cangrelor

Gland Pharma believes that they are amongst one of the first to file for this product and may be eligible for 180 days of generic drug exclusivity


Unichem Labs gets ANDA approval for schizophrenia medicine
Drug Approval | December 03, 2021

Unichem Labs gets ANDA approval for schizophrenia medicine

The product will be commercialized from Unichem's Ghaziabad plant


Obseva announces U.S. FDA acceptance of new drug application for linzagolix
Biotech | November 23, 2021

Obseva announces U.S. FDA acceptance of new drug application for linzagolix

Obseva announced previously that the company has entered into a partnership with Syneos Health to support commercialization of linzagolix in the US and EU


Gland Pharma receives tentative nod for Sugammadex injection
Drug Approval | October 09, 2021

Gland Pharma receives tentative nod for Sugammadex injection

The injection is used to reverse the effects of the muscle relaxants given to patients during surgery