Drug Approval | 18 April 2022
Amneal achieves second U.S. biosimilars approval with Alymsys
Marks the second of three biosimilars Amneal expects to receive U.S. approval for in 2022
Marks the second of three biosimilars Amneal expects to receive U.S. approval for in 2022
This product will be manufactured at Lupin’s Nagpur facility in India
The drug will be manufactured at the group's injectables manufacturing facility at Jarod, Gujarat
Ocular hypertension affects over 5% of all adults; the eye does not properly drain fluid, causing eye pressure to build up
The product will be manufactured at Lupin’s facility in Goa, India
Lidocaine and Prilocaine Cream USP, 2.5%/2.5% has an estimated market size of US $ 29 million for twelve months ending Dec. 2021 according to IQVIA
The tentatively approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) Pradaxa Capsules of Boehringer lngelheim
Merzee is a generic equivalent of Taytulla of Allergan Pharmaceuticals International
Immunocin, an Immuno-modulator drug, significantly reduced the risk of death in the Phase 3 clinical trial in adult patients with moderate-to-severe Covid-19
Aveir VR is specifically designed to be retrieved when therapy needs to evolve or the device needs to be replaced
Ondexxya is the first approved reversal agent specifically for Factor Xa inhibitors, providing a major advance in the treatment of patients hospitalised with life-threatening bleeding
Approval is based on results of a multicenter, randomized, open-labeled and controlled IDE clinical study that demonstrated the superiority of Agili-C™ implant to the current surgical standard of care, debridement and microfracture in the knee joint
Ozempic is now approved in the US at 0.5 mg,1.0 mg and 2.0 mg doses for the treatment of type 2 diabetes in adults
Tardive dyskinesia (TD) is a movement disorder that is characterized by uncontrollable, abnormal and repetitive movements of the face, torso and/or other body parts, which may be disruptive and negatively impact patients
In May 2021, Daiichi Sankyo had submitted a supplemental new drug application (sNDA) for Tarlige tablets based on results from a phase 3 trial in patients with CNP
Evusheld significantly reduced the risk of developing symptomatic COVID-19 in PROVENT Phase III trial, with protection lasting at least six months
It also empowers domestic precision immunotherapy for tumours and promotes the high-quality development of China's biopharmaceutical industry
Aquavit will officially unveil the Dermatox and Microtox programs at the Annual American Academy of Dermatology, the world's largest dermatology conference scheduled from March 25-29, 2022, in Boston, MA
Cabenuva was co-developed as part of a collaboration with ViiV Healthcare and builds on Janssen's decades-long commitment to combatting HIV
This is the first CAR T cell therapy application filed for the second-line treatment of R/R LBCL in Japan
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