Regulatory | 28 December 2021
Sun Pharma receives DCGI approval for Molxvir in India
The product is expected to be available in a week’s time
The product is expected to be available in a week’s time
It plans to deliver over 300 million doses to the Indian government
Natco Pharma has received approval for Covid 19 drug molnupiravir capsules 200 mg. for Indian market, which will be sold under brand name Molnunat
DCGI approved the drug based on the review of clinical data
Molnupiravir is an orally administered form of a potent ribonucleoside analog that inhibits the replication of SARS-CoV-2
The company will market it under the brand name Molflu
The drug will be marketed under the brand name Molnaflu
The company has developed the API in house at its R&D center in Hyderabad
Covaxin is formulated uniquely such that the same dosage can be administered to adults and children
This product will be manufactured at Lupin's Goa facility in India
Pfizer raises production projections from 80 million to 120 million courses of treatment in 2022, as a result of continued investments to support the manufacturing and distribution of Paxlovid
With two maintenance doses a year, Leqvio is the first and only FDA-approved small interfering RNA (siRNA) therapy for LDL-C (bad cholesterol) reduction1
The approval of shelf life extension is based on the availability of additional stability data, which was submitted to the CDSCO
Given as few as six times per year and demonstrated superior efficacy to a daily oral PrEP option (FTC/TDF tablets) in reducing the risk of HIV acquisition
The NMPA approval is based on the positive data of GEMSTONE-302 study, a multi-center, randomized, double-blind, phase III study that evaluated the efficacy and safety of Cejemly or placebo in combination with chemotherapy in first-line stage IV NSCLC patients
Prucalopride medicine in the form of Orally Disintegrating Strips are most convenient dosage form for geriatric patients
The capsules are the generic version of the reference listed drug Mycobutin
It is indicated for the treatment of patients with acromegaly and Gastroenteropancreatic Neuroendocrine Tumours
First Emergency Use Listing granted by WHO for a protein-based Covid-19 vaccine
It is the first approved generic and is eligible for 180 days of Competitive Generic Therapy exclusivity
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