Abbott Laboratories and Forest Pharmaceuticals, manufacturer of Levothroid, filed New Drug Applications
in August but had not received approval at press time.
The United States Food and Drug Administration (FDA) has received a New Drug Application
(NDA) seeking approval for Israel-based Foamix Pharmaceuticals Ltd's (Nasdaq: FOMX) FMX103 intended for the treatment of moderate-to-severe papulopustular rosacea in patients 18 years of age and older, it was reported yesterday.
Recently the FDA accepted Discovery's New Drug Application
for Surfaxin for the prevention of RDS in premature infants and has granted a PDUFA date of February 13, 2005.
The multiple components of the overall process including discovery, efficacy testing, development of lead agents, toxicology and pharmacology, investigational new drug application
filing, and clinical evaluation may require years and several million dollars.
On October 3, 2001, the committee will discuss new drug application
(NDA) 21-356, for Viread[TM], (tenofovir disoproxil fumarate) Tablets, proposed for the treatment of Human Immunodeficiency Virus (HIV) infection.
M2 PHARMA-July 29, 2019-US FDA accepts Epizyme's Tazemetostat New Drug Application
M2 EQUITYBITES-July 29, 2019-US FDA accepts Epizyme's Tazemetostat New Drug Application
Tokyo, Japan, Nov 30, 2006 - (JCN) - Toray, JT and Torii Pharmaceutical announced November 28 that the companies have filed for a new drug application
in Japan for TRK-820, an antipruritic agent originally discovered by Toray.
The United States Food and Drug Administration (FDA) has received a new drug application
(NDA) from United States-based Epizyme for accelerated approval of Tazemetostat intended for the treatment of patients with metastatic or locally advanced epithelioid sarcoma not eligible for curative surgery, it was reported on Friday.
SpecGx, a subsidiary of Mallinckrodt that operates its specialty generics business, announced that it has received a complete response letter, or CRL, from the FDA related to its new drug application
, or NDA, for its investigational abuse-deterrent, immediate-release reformulation of Roxicodone tablets, USP for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.
Going forward, Beijing Tide Pharmaceutical will conduct clinical trials in China and file a new drug application
It was reported yesterday that United States-based Kala Pharmaceuticals has submitted a new drug application
for its KPI-121 0.25% product candidate to the US Food and Drug Administration (USFDA).