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Articles for Regulatory

Zydus Lifesciences Gets Two Approvals From USFDA For Silodosin, Pregabalin Capsules

Zydus Lifesciences Silodosin capsules are indicated to treat signs and symptoms of an enlarged prostate gland, which is also known as benign enlargement of the prostate, whereas Pregabalin capsules are indicated to treat pain caused by nerve damage due to diabetes or shingles

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USFDA To Prioritise Regulation On Homeopathic Drugs Marketed In US

The top US regulator said that it has developed a risk-based approach under which the agency intends to prioritise specific categories of homoeopathic drug products that potentially pose a higher risk to public health

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Alembic Receives USFDA Approval For Diclofenac Sodium Topical Solution

Alembic's approved Diclofenac Sodium Topical Solution is indicated for the treatment of the pain of osteoarthritis of the knee

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Zydus Gets USFDA Nod For Topiramate Extended-release Capsules

Zydus Lifesciences has received final approval from the United States Food and Drug Administration (USFDA) to market Topiramate Extended-Release Capsules, 25 mg, 50 mg, 100 mg, 150 mg, and 200 mg

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USFDA Disapproves Spectrum Pharma's Lung Cancer Drug

The company now plans to de-prioritize the development of the drug, called poziotinib, and said it was in the process of cutting 75 per cent of its research and development workforce

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USFDA Approves Provention Bio's Diabetes Drug

The U.S. health regulator has allowed teplizumab, to be sold under the brand name Tzield, for patients with stage 2 of the disease who have two or more disease autoantibodies and abnormality in blood sugar stability, Provention Bio said

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USFDA Completes Pre-approval Inspection Of Bajaj Healthcare's Vadodra Facility

The pre-approval inspection of USFDA has been completed successfully with ZERO 483 observations of the manufacturing facilities of Bajaj Healthcare, the company's statement read

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Sanofi, AstraZeneca Get EU Nod For Beyfortus To Prevent Infant RSV

RSV causes thousands of hospitalisations and deaths globally each year in toddlers and the elderly, but the complex molecular structure of the virus and safety concerns have stymied efforts to develop a vaccine since the virus was first discovered in 1956

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