Briefs: Dr. Reddy's Laboratories

USFDA has issued Form 483 with one observation

Zydus receives final approval from the USFDA for Sucralfate Tablets USP, 1 gram

Hyderabad startup’s Physiotherapy monitoring device ‘Pheezee’ receives USFDA

Pheezee is designed to assess musculoskeletal and neuromuscular health.

USFDA puts on hold Sun Pharma trials on dermatological drug

Sun Pharma said had a teleconference call with the US Food and Drug Administration (USFDA) regarding a pulmonary embolism (serious adverse events) occurring at the 12 mg dose

Indoco receives EIR for its Plant I manufacturing facility in Goa

Indoco expects this change in compliance status to pave the way for approvals of ANDAs submitted from this site.

USFDA Advisory Committee votes n Lynparza plus Abiraterone and Prednisone for prostate cancer

The committee voted that FDA should restrict use of LYNPARZA plus abi/pred to these BRCAm mCRPC patients

Zydus receives final approval from the USFDA for Metronidazole Topical Cream

Metronidazole is an antibiotic used on the skin to treat a certain skin disorder known as rosacea

Zydus receives final approval from the USFDA for Icosapent Ethyl Capsules

Icosapent Ethyl Capsules are indicated as an adjunct to diet to reduce triglyceride levels

USFDA lifts clinical hold on Phase 3 investigational new drug application for MaaT013

This is the first time the Agency has authorized the Phase 3 clinical evaluation in the U.S of a microbiota-based live biotherapeutic based on a pooling technology

Ajinomoto Bio-Pharma receives FDA approval for high potency fill line

Aji Bio-Pharma has six fill finish lines located in San Diego, including a new line