USFDA approves BMS’ Reblozyl as first-line treatment of anemia in adults with Myelodysplastic Syndromes

Reblozyl is the first and only therapy to demonstrate superiority compared to an erythropoiesis stimulating agent (ESA) in MDS-related anemia

Strides receives USFDA approval for Mycophenolate Mofetil for oral suspension

The approval bolsters the company's Mycophenolate Mofetil portfolio

Lupin receives USFDA approval for Pirfenidone Capsules

Pirfenidone Capsules had estimated annual sales of USD 95 million in the US

Ajanta Pharma receives USFDA for Topiramate Extended Release Capsules

Topiramate is the generic version of Supernus Pharmaceuticals’ Trokendi XR

Lupin receives approval from USFDA for Pirfenidone Tablets

This product will be manufactured at Lupin's Pithampur facility in India

Zydus receives final approval from the USFDA for zinc sulfate injection pharmacy bulk package vials

Zinc Sulfate Injection is indicated in adult and paediatric patients as a source of zinc for parenteral nutrition

Marksans receives USFDA approval for Guaifenesin Extended-Release Tablets

Guaifenesin extended-release tablets help to loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

Lupin receives approval from USFDA for Bromfenac Ophthalmic

Bromfenac Ophthalmic Solution 0.09% (RLD Bromday) had estimated annual sales of USD 11 million in the U.S. (IQVIA MAT June 2023).

Hikal receives Brazilian GMP certification and USFDA EIR for Bangalore and Panoli facilities

Lupin's Mandideep Unit-2 facility completes USFDA inspection with no observations

The inspection was conducted from August 7 to August 11, 2023 and concluded without any observations.