Indian Pharma Receives USFDA Approval For Anti-Psychotic Drugs

Hyderabad-based Aurobindo Pharma received the final approval from the US Food and Drug Administration to manufacture and market generic Aripiprazole tablets used for treatment of psychotic conditions in the American market.

"The company //has received the final approval from the USFDA to manufacture and market Aripiprazole tablets. The product is ready for launch," Aurobindo Pharma said in a statement.

USFDA Orders Tobacco Giant To Stop Sales And Distribution Of 4 Varieties Of Cigarettes
The 4 products are Camel Crush Bold, Pall Mall Deep Set Recessed Filter, Pall Mall Deep Set Recessed Filter Menthol and Vantage Tech 13 cigarettes.

The approval is for the tablets in the strengths of 2mg, 5mg, 10mg, 15mg, 20mg and 30mg, it added.

The approved ANDA (Abbreviated New Drug Application) is for the generic version of Otsuka Pharmaceutical's Abilify tablets in the same strengths, Aurobindo Pharma said.

The approved product has an estimated market size of USD 7.3 billion for 12 months ending August, the company said stating IMS estimates.

Tandem Diabetes Care Gains USFDA Approval for CGM Integrated Insulin Pump
The device allows diabetics to keep a close eye on how their blood glucose levels respond to insulin injections, and makes it easier to achieve optimal insulin dosage.

"Aripiprazole tablets are atypical antipsychotic indicated in the treatment symptoms of psychotic conditions such as schizophrenia and bipolar disorder (manic depression)," Aurobindo said.

The company now has a total of 215 ANDA approvals (187 final approvals including 10 from Aurolife Pharma LLC and 28 tentative approvals) from USFDA, it added.

USFDA Raises Doubts Over Effectiveness Of Purdue Pharma's Fast-Acting Painkiller
The drug is designed to be taken every 4-6 hours on an empty stomach as the absorption of oxycodone from the drug can be delayed in the presence of food.

Source-PTI

Swiss Drug-maker Gets Breakthrough Therapy Designation From USFDA For Its Hemophilia Drug
Roche said ACE910 secured fast-track designation as they prepare separate Phase III trials, the first in patients with haemophilia A with factor VIII inhibitors.