Drug Approval | 15 November 2021
Zydus Cadila receives tentative approval for IBS tablets
The group now has 324 approvals and has so far filed over 400 ANDAs
The group now has 324 approvals and has so far filed over 400 ANDAs
The European Commission (EC) granted marketing authorisation for Celltrion’s regdanvimab following a positive opinion by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) last week
Data demonstrates Ronapreve reduced risk of hospitalisation in certain patients and reduced risk of symptomatic Covid-19 infections in people exposed to the virus
The Drug Controller General of India (DCGI), is reviewing clinical data of molnupiravir for the treatment of Covid-19 in adults in India
Glycopyrrolate injection can also be used in adults as an adjunctive therapy for the treatment of gastrointestinal ulcer when a rapid effect is desired or when oral medication is not tolerated
The drug helps in managing cholesterol
The Akovaz brand and generic market had U.S. sales of approximately US $ 67.5 million MAT for the most recent twelve months ending in August 2021
It is the first U.S. FDA approved novel topical mechanism for acne in nearly 40 years
Generalized pustular psoriasis is characterized by episodes of widespread eruptions of painful, sterile pustules
Moderate-to-severe plaque psoriasis affects about 35 per cent of patients. A key challenge is that many treatments stop working overtime and symptoms return
It is the first company to launch Remogliflozin, Vildagliptin and Metformin combination
The implant is surgically inserted into the eye during a one-time, outpatient procedure and refilled every six months
Dupixent is the only biologic medicine to improve lung function in children aged 6 to 11 years in a randomized Phase 3 trial, supporting potential as a best-in-class option
The authority also allowed mix and match of booster doses once the primary vaccine has been administered.
Second interchangeable biosimilar product approved by agency
The company is eligible for 180 days of generic drug exclusivity for Lenalidomide capsules, 2.5 mg and 20 mg
The company claims that its Empagliflozin tablets are the most affordable in India
Tecentriq is the first and only cancer immunotherapy approved for NSCLC in the adjuvant setting
The capsules are indicated for the maintenance of normal sinus rhythm in patients with atrial fibrillation/atrial flutter of greater than one week duration who have been converted to normal sinus rhythm
The BiCNU brand and generic market had U.S. sales of approximately US $ 19.4 million MAT for the most recent twelve months ending in August 2021, according to IQVIA Health
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