Enhertu granted Priority Review in the US for patients with metastatic HER2-positive solid tumours

Submission to be reviewed under FDA real-time oncology review and Project Orbis

Zydus receives USFDA’s final approval for Gabapentin Tablets, 300 mg and 600 mg

Gabapentin is indicated for the management of Postherpetic Neuraligia

Lupin receives tentative USFDA approval for Rivaroxaban Tablets USP

Lupin receives USFDA’s approval for Febuxostat Tablets

Febuxostat Tablets (RLD Uloric) had estimated annual sales of US$ 27 million in the U.S. (IQVIA MAT November 2023)

Zydus receives USFDA’s approvals for Pimavanserin Capsules, 34 mg and Pimavanserin Tablets,10 mg

Pimavanserin is an atypical antipsychotic indicated for the treatment of hallucinations and delusions associated with Parkinson disease psychosis

Bayer, Sun Pharma sign marketing and distribution agreement for second brand of Finerenone in India

Bayer has granted the non-exclusive rights to Sun Pharma to market and distribute a second brand of Finerenone under the brand name Lyvelsa

Lupin receives USFDA’s approval or Propranolol Hydrochloride Extended-Release Capsules USP

USFDA approves Merck’s Keytruda plus chemoradiotherapy with FIGO 2014 stage III-IVA cervical cancer

Keytruda is the first and only anti-PD-1 therapy approved in combination with chemoradiotherapy for these patients

Lupin launches Varenicline Tablets in US

Varenicline Tablets (RLD Chantix) had estimated annual sales of US $412 million in the US

Unichem receives ANDA approval for Doxazosin Tablets

Doxazosin tablets are indicated for the treatment of hypertension, to lower blood pressure