Drug Approval | January 17, 2022
Glenmark Pharmaceuticals receives ANDA tentative approval for Regadenoson injection
The company has 47 ANDA's pending approval with the U.S.FDA
The company has 47 ANDA's pending approval with the U.S.FDA
The company has 271 cumulative ANDA filings with USFDA of which 243 ANDAs have been approved and 28 are pending approval
Dronedarone tablets USP, 400 mg have an estimated market size of US $ 500 million for twelve months ending September 2021 according to IQVIA
Entacapone tablets USP, 200 mg have an estimated market size of US$ 10.5 million for twelve months ending September 2021, according to IQVIA
Doxycycline Hyclate Delayed Release tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria
The current annual U.S. market for amphetamine mixed salts, USP 1.25mg, 1.875mg, 2.5mg, 3.125mg, 3.75mg, 5mg, 7.5mg immediate release tablets strengths is approximately US $ 335 million, according to MAT, Oct 2021 IQVIA/IMS Health
The current annual U.S. market for prazosin hydrochloride 1mg, 2mg, 5mg strengths is approximately US $ 54 million, according to IQVIA/IMS Health
This product will be manufactured at Lupin's Goa facility in India
The capsules are the generic version of the reference listed drug Mycobutin
It is indicated for the treatment of patients with acromegaly and Gastroenteropancreatic Neuroendocrine Tumours
Subscribe To Our Newsletter & Stay Updated
