Bioequivalence and Bioavailability Forum

Anand ☆ India, 2014-10-17 08:34 (3472 d 03:13 ago) Posting: # 13740 Views: 2,116	Desmopressin Acetate RLD confirmation USFDA [Regulatives / Guidelines] Post reply
	Dear All, Request to clarify DESMOPRESSIN ACETATE Tablets 0.2mg RLD confirmation, DDAVP 0.2mg (SANOFI AVENTIS US) RLD -- Yes DESMOPRESSIN ACETATE 0.2mg (FERRING) RLD -Yes Which should consider RLD for DESMOPRESSIN ACETATE Tablets 0.2mg Thanks in Advance Regards, Anand Edit: Changed subject line from all-capital letters. [Helmut]

priya ☆ India, 2014-10-17 13:56 (3471 d 21:52 ago) @ Anand Posting: # 13741 Views: 1,783	Desmopressin Acetate RLD confirmation USFDA Post reply
	Dear Anand, You can use any one of the those two RLD (either DDAVP of Sanofi or Desmopression of Ferring) since FDA listed both the products as Reference Listed Drug (RLD). FDA approved Sanofi's DDAVP as NDA with NDA application no. 019955 on September 6, 1995. FDA also approved Ferring's Desmopressin through NDA section 505(b)(2) route with NDA application no. 021795 on May 8, 2008. Priya.

Helmut ★★★ Vienna, Austria, 2014-10-17 18:47 (3471 d 17:01 ago) @ Anand Posting: # 13747 Views: 1,707	We are not hearing &\| visually impaired Post reply
	Hi Anand, why are you shouting at us? Or is your ⇧-key jammed? You should repair or replace it. Please follow the Forum’s Policy. — Dif-tor heh smusma 🖖🏼 Довге життя Україна! Helmut Schütz The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes

Desmopressin Acetate RLD confirmation USFDA [Regulatives / Guidelines]