Industry News

Zydus Lifesciences Limited has received final approval from the United States Food and Drug Administration (USFDA) to manufacture and market Ephedrine Sulfate Injection USP, 50 mg/mL single-dose vials (USRLD: Akovaz® Injection).

Ephedrine Sulfate Injection is indicated for the treatment of clinically important hypotension occurring in the setting of anesthesia. The drug will be manufactured at the group’s injectable manufacturing facility at Jarod, near Vadodara (India).

Astellas Pharma Inc. announced that the U.S. Food and Drug Administration (FDA) has approved VEOZAHTM (fezolinetant) 45 mg once daily for the treatment of moderate to severe vasomotor symptoms (VMS) due to menopause1 on May 12. VEOZAH is the first nonhormonal neurokinin 3 (NK3) receptor antagonist approved to treat VMS due to menopause.

The Zydus Group with an overarching purpose of empowering people with freedom to live healthier and more fulfilled lives, is an innovative, global lifesciences company that discovers, develops, manufactures, and markets a broad range of healthcare therapies. The group employs over 23000 people worldwide and is driven by its mission to unlock new possibilities in life- sciences through quality healthcare solutions that impact lives.

Global pharma major Lupin Limited announced that it has entered into a definitive agreement to acquire the entire share capital of the French pharmaceutical company, Medisol, subject to approval from the French Ministry of Economy and Finance.

Dr. Reddy's Laboratories Ltd. launched Regadenoson Injection in the U.S. market, a generic therapeutic equivalent of Lexiscan (Regadenoson) injection, approved by U.S. Food and Drug Administration (USFDA).

Lexiscan is a registered trademark of Astellas US LLC. It is an A2A adenosine receptor agonist that is a coronary vasodilator that is commonly used in pharmacologic stress testing. It produces hyperemia quickly and maintains it for a duration that is useful for radionuclide myocardial perfusion imaging.

Zydus Life Sciences Limited has received final approval from the United States Food and Drug Administration (USFDA) to manufacture and market Sucralfate Tablets USP, 1 gram (USRLD: Carafate Tablets, 1 gram).

Sucralfate is used to treat and prevent ulcers in the intestines by forming a coating over ulcers, protecting the area from further injury. This helps ulcers heal more quickly. The drug will be manufactured at the group’s topical manufacturing facility at SEZ, Ahmedabad (India).

AstraZeneca Pharma India has received a permission in Form CT-20 to Import for sale and distribution of Trastuzumab deruxtecan (Enhertu) 100mg/5mL vial lyophilized powder for concentrate for solution for infusion from the Central Drugs Standard Control Organisation, Directorate General of Health Services, Government of India.

FDA halts clinical trials of Deuruxolitinib due to the potential for thrombotic events seen in subjects. FDA has placed the IND on partial clinical hold and are requiring that subjects currently on studies to discontinue the dose.

It has been noted by the FDA that pulmonary embolism (Serious Adverse Events) occurring at the 12 mg BID dose in one of the long-term Open Label Extension (OLE) studies of Deuruxolitinib.

Astellas Pharma Inc and Pfizer Inc announced that XTANDI® (enzalutamide) plus leuprolide significantly reduced the risk of metastasis or death by 58% versus placebo plus leuprolide (Hazard Ratio [HR]: 0.42; 95% Confidence Interval [CI], 0.30–0.61; P<0.0001), as assessed by the primary endpoint of metastasis-free survival (MFS), in men with non-metastatic hormone-sensitive prostate cancer (nmHSPC; also known as non-metastatic castration-sensitive prostate cancer or nmCSPC) with high-risk biochemical recurrence (BCR).