Drug Approval | 21 September 2023
Zydus receives final approval from the USFDA for Clindamycin Phosphate Gel USP, 1%
Clindamycin Phosphate Gel is used to treat acne
Clindamycin Phosphate Gel is used to treat acne
InvaGen has received 5 inspectional observations in Form 483
Norepinephrine Bitartrate Injection is used for restoration of blood pressure in adult patients
Approval is for use in myelofibrosis patients with anaemia regardless of prior myelofibrosis therapy
Opinion granted based on positive disease-free survival results from the Phase 3 KEYNOTE-091 trial
Approval of this product under the PEPFAR program completes Strides’ qualification to all major markets and donor programs including Global Fund and South Africa
Norelgestromin and Ethinyl Estradiol Transdermal System, 150 mcg/35 mcg per day had annual sales of US $330 million in the United States
The products will be manufactured at the company's facility in Bengaluru
The company has received the Establishment Inspection Report (EIR) from the USFDA for the Pre-Approval Inspection (PAI) at a manufacturing site situated at Savli, Vadodara, Gujarat, with Zero 483 observations
Parecoxib Sodium is the first parenteral selective COX-2 inhibitor available for clinical use in pain management
The products will be manufactured at the company's facility in Bengaluru
The inspection classification was determined by the agency as Voluntary Action Indicated
Erythromycin tablets is used to prevent and treat infections in many different parts of the body
The inspection has concluded successfully on 1st September 2023 without any critical/major observation
Reblozyl is the first and only therapy to demonstrate superiority compared to an erythropoiesis stimulating agent (ESA) in MDS-related anemia
The approval bolsters the company's Mycophenolate Mofetil portfolio
Pirfenidone Capsules had estimated annual sales of USD 95 million in the US
Prasugrel tablets are indicated to reduce the rate of thrombotic CV events
Topiramate is the generic version of Supernus Pharmaceuticals’ Trokendi XR
KEYTRUDA is the first immunotherapy approved in the EU for the first-line treatment of this patient population
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