Latest news and insights on the pharmaceutical industry | Indian Pharma Post | Page 18
Drug Approval
Drug Approval | 07 March 2023

USFDA approves intramuscular administration for Merck’s MMRV family of vaccines

With this additional route of administration, the MMRV Family now joins other routinely recommended vaccines that can be administered intramuscularly

Drug Approval
Drug Approval | 06 March 2023

Zydus receives final approval from the USFDA for Vigabatrin for Oral Solution

Vigabatrin for Oral Solution USP, 500 mg had annual sales of US $233.7 mn in US

Drug Approval
Drug Approval | 04 March 2023

Caplin Steriles gets USFDA approval for Rocuronium Bromide Injection

Rocuronium Bromide Injection is a neuromuscular blocking agent

Drug Approval
Drug Approval | 04 March 2023

Zydus receives final approval from the USFDA for Vigabatrin for Oral Solution

Vigabatrin for Oral Solution USP, 500 mg had annual sales of USD 233.7 mn in the United States

Drug Approval
Drug Approval | 03 March 2023

Zydus receives final approval from the USFDA for Acyclovir Cream

he product will be launched shortly in the US market.

Drug Approval
Drug Approval | 01 March 2023

Zydus receives final approval from the USFDA for Apixaban Tablets

Apixaban Tablets, 2.5 mg and 5 mg had annual sales of USD 18,876 mn in the United States (IQVIA MAT Dec. 2022).

Drug Approval
Drug Approval | 01 March 2023

Zydus receives final approval from the USFDA for Hydrochlorothiazide Tablets

This combination medicine is used to treat high blood pressure (hypertension).

Drug Approval
Drug Approval | 28 February 2023

Venus Remedies awarded Saudi GMP approval for all its production facilities in Baddi

The company expects the GMP approval from Saudi Food and Drug Authority (SFDA) to soon pave the way for marketing authorizations from the largest market in the GCC region

Drug Approval
Drug Approval | 27 February 2023

Granules India gets USFDA approval for Losartan Potassium Tablets USP, 25 mg, 50 mg, and 100 mg

Losartan potassium tablets are indicated for the treatment of hypertension in adults and pediatric patients 6 years of age and older, to lower blood pressure.

Drug Approval
Drug Approval | 27 February 2023

Biliary tract cancer drug Durvalumab approval key opportunity for AstraZeneca in India, says GlobalData

The British-Swedish pharma major certainly has a strong competitive edge for BTC treatment in the country

Drug Approval
Drug Approval | 25 February 2023

Pfizer and BioNTech submit sBLA for approval of Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine

This sBLA submission is supported by clinical, pre-clinical, and manufacturing data demonstrating the safety, tolerability, and immunogenicity of the bivalent vaccine.

Drug Approval
Drug Approval | 25 February 2023

Pfizer’s Elranatamab receives FDA and EMA filing acceptance

Submissions based on favorable MagnetisMM-3 trial results in patients with relapsed or refractory multiple myeloma

Drug Approval
Drug Approval | 24 February 2023

SERDA therapeutics submits IND for wound debridement agent

Clinical studies are expected to start in Q2 2023.

Drug Approval
Drug Approval | 23 February 2023

Moderna and Merck announce investigational personalized cancer vaccine mRNA-4157/V940

Designation based on positive data from Phase 2b KEYNOTE-942/mRNA-4157-P201 trial

Drug Approval
Drug Approval | 22 February 2023

USFDA accepts biologics license application for Pfizer’s respiratory syncytial virus maternal vaccine candidate for priority review

This action follows the recent acceptance of the Marketing Authorization Application (MAA) for Pfizer’s RSV vaccine candidate by the European Medicines Agency

Drug Approval
Drug Approval | 21 February 2023

Astellas updates on Fezolinetant application in US

Astellas stands on the forefront of healthcare change to turn innovative science into value for patients

Drug Approval
Drug Approval | 20 February 2023

Briefs: Neuland Laboratories, Cipla and Zydus

Cipla has received 8 inspectional observations in Form 483

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