Pfizer’s anti-infectives portfolio includes both established therapies for moderate to severe infections and newer, clinically robust antimicrobial treatments
The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Stalevo Tablets
Leading the showcase is FCT iStream, Fujifilm’s latest CT scanner built on a “Less is More” design philosophy
The pharmaceutical giant said it would pursue legal and regulatory action following Hims & Hers
HYMPAVZI is already approved in the US for patients 12 and older with hemophilia A without factor VIII inhibitors or hemophilia B without factor IX inhibitors
Under the agreement, Apotex’s branded division, Searchlight Pharma, will seek regulatory approval and handle marketing and distribution in Canada
On segmental performance, API revenues were largely stable at Rs. 454.3 crore for Q3 FY26, down 1% YoY
A final decision on the updated application is expected in the first half of 2026, while intravenous (IV) Saphnelo remains commercially available
Topiramate Extended-Release Capsules are bioequivalent to the reference listed drug (RLD), Trokendi XR Extended-Release Capsules of Supernus Pharmaceuticals
The FDA’s regulatory decision is expected in Q2 2026 under the Prescription Drug User Fee Act (PDUFA)
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