Drug Approval | December 01, 2022
JB Pharma gets USFDA approval for its generic Venlafaxine Extended-Release Tablets
This product is based on Osmotic Controlled Release Oral Delivery System technology
This product is based on Osmotic Controlled Release Oral Delivery System technology
Approval broadens indication for ENHERTU to earlier use in metastatic breast cancer and requirement for confirmatory phase 3 trial
Nifedipine Extended-Release Tablets have an estimated market size of US $56 million for twelve months ending September 2022
The drug will be manufactured at the group’s formulation manufacturing facility at Ahmedabad SEZ, India
Drospirenone Tablets (RLD Slynd) had estimated annual sales of US $141 million in the US
Glenmark’s Sodium Phenylbutyrate Tablets USP, 500 mg, will be distributed in the U.S. by Glenmark Pharmaceuticals USA.
The voluntary program is the first time the FDA will allow excipient manufacturers to obtain review of certain novel excipients prior to their use in drug formulations.
The expansion program includes investments in France and the U.S., adding an additional 23,000+ m² of manufacturing footprint.
Ketorolac Tromethamine Tablets are indicated to relieve moderately severe pain, usually after surgery.
Paliperidone Extended-Release Tablets (RLD Invega) had estimated annual sales of USD 112 million in the U.S. (IQVIA MAT August 2022).
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