Drug Approval | 28 December 2021
Aurobindo to manufacture and market molnupiravir
The drug will be marketed under the brand name Molnaflu
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
Orencia is the first FDA-approved therapy to prevent acute graft versus host disease following hematopoietic stem cell transplant
The group now has 325 approvals and has so far filed over 400 ANDAs since the commencement of the filing process in FY 2003-04.
The tablets are available in 150 mg and 225 mg strengths in bottle count sizes of 30 and 90.
Brii Bio announces amubarvimab/romlusevimab combination received approval from NMPA
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
The tablets are indicated for the treatment of pulmonary arterial hypertension
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