Drug Approval | November 15, 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 submission is based on Phase 2/3 study of mRNA-1273 in children ages 6 to 11
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
Filing marks first protein-based vaccine submitted to MHRA for authorization
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 company is eligible for 180 days of generic drug exclusivity for Lenalidomide capsules, 2.5 mg and 20 mg
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 company’s pharmaceutical API products Ibuprofen and fenofibrate got the go-ahead
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The two doses of Covaxin are likely to be administered to children with a gap of 28 days
The company plans to expand its portfolio in regulated markets aggressively
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