Drug Approval | November 09, 2022
Lupin receives tentative approval from USFDA for Doxycycline Capsules
Doxycycline Capsules (RLD Oracea) had estimated annual sales of US $215 million in the US
Doxycycline Capsules (RLD Oracea) had estimated annual sales of US $215 million in the US
The company has successfully developed Methyl salicylate using Flow Chemistry and successfully erected a Flow reactor at Jhagadia plant and expects to start production from Q3 FY23
The acquisition is for an enterprise value of Rs. 218 crores
Drospirenone Tablets (RLD Slynd) had estimated annual sales of US $141 million in the US
Phase III trial also demonstrated a statistically significant reduction (14%) in hospitalization for any cause, bringing potential relief for patients and reducing burden on healthcare systems
Saroglitazar Mg is an investigational compound in the USA/EU, undergoing Phase 2b/3 clinical trials in patients with Primary Biliary Cholangitis and Phase 2b in patients with Non- alcoholic Steatohepatitis
Ketorolac Tromethamine is advised for the short-term management of moderately severe acute pain in adult patients
Mesalamine Extended-Release Capsules are indicated for the maintenance of remission of ulcerative colitis in adults.
Glenmark’s Sodium Phenylbutyrate Tablets USP, 500 mg, will be distributed in the U.S. by Glenmark Pharmaceuticals USA.
According to IQVIA sales data for the 12-month period ending September 2022, the Gilenya Capsules, 0.5 mg market achieved annual sales of approximately US $1.8 billion
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