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Results For "United-States"

1202 News Found

Lupin receives tentative approval from USFDA for Drospirenone Tablets
Drug Approval | November 07, 2022

Lupin receives tentative approval from USFDA for Drospirenone Tablets

Drospirenone Tablets (RLD Slynd) had estimated annual sales of US $141 million in the US


Glenmark receives ANDA approval for Sodium Phenylbutyrate Tablets
Drug Approval | November 03, 2022

Glenmark receives ANDA approval for Sodium Phenylbutyrate Tablets

Glenmark’s Sodium Phenylbutyrate Tablets USP, 500 mg, will be distributed in the U.S. by Glenmark Pharmaceuticals USA.


Ashland injectable pharmaceutical excipient accepted into FDA Novel Excipient Review Pilot Program
Drug Approval | November 01, 2022

Ashland injectable pharmaceutical excipient accepted into FDA Novel Excipient Review Pilot Program

The voluntary program is the first time the FDA will allow excipient manufacturers to obtain review of certain novel excipients prior to their use in drug formulations.


Zydus receives final approval from USFDA for Acetaminophen injection
Drug Approval | October 30, 2022

Zydus receives final approval from USFDA for Acetaminophen injection

Acetaminophen injection had annual sales of US $72 million in the United States according to IQVIA data


Gland Pharma’s Q2 FY23 revenue stood at Rs. 1,044.4 Cr
News | October 27, 2022

Gland Pharma’s Q2 FY23 revenue stood at Rs. 1,044.4 Cr

Gland Pharma Q2 FY2023 consolidated net profit up at Rs. 241.24 Cr


Zydus gets USFDA’s approval for Ketorolac Tromethamine Tablets
Drug Approval | October 27, 2022

Zydus gets USFDA’s approval for Ketorolac Tromethamine Tablets

Ketorolac Tromethamine Tablets are indicated to relieve moderately severe pain, usually after surgery.


Zydus receives final approval from USFDA for Micafungin for Injection
Drug Approval | October 26, 2022

Zydus receives final approval from USFDA for Micafungin for Injection

Micafungin for Injection had annual sales of US $99 million in the United States according to IQVIA data


Merck’s PREVYMIS effective for prevention of cytomegalovirus disease in adults post kidney transplantation
Clinical Trials | October 23, 2022

Merck’s PREVYMIS effective for prevention of cytomegalovirus disease in adults post kidney transplantation

Separate Phase 3 study evaluating 200 days of therapy with PREVYMIS in HSCT recipients at high risk of late clinically significant CMV infection recently completed, meeting its primary endpoint


USFDA visit to Alembic Pharmaceuticals Panelav facility
Drug Approval | October 19, 2022

USFDA visit to Alembic Pharmaceuticals Panelav facility

None of the observations are related to data integrity and Alembic Pharmaceuticals management believes that they are addressable


Merck and the Bill & Melinda Gates Medical Research Institute announce licensing agreement for tuberculosis antibiotic candidates
News | October 19, 2022

Merck and the Bill & Melinda Gates Medical Research Institute announce licensing agreement for tuberculosis antibiotic candidates

The TBDA is a collaboration established among biopharmaceutical companies, research organizations and universities to accelerate the discovery and development of novel therapeutic candidates against TB.