The US FDA should consider increasing the number of patients required for new drug application clinical trials

Reactions Weekly ◽

10.2165/00128415-199907520-00004 ◽

1999 ◽

Vol &NA; (752) ◽

pp. 2

Author(s):

&NA;

Keyword(s):

Clinical Trials ◽

Drug Application ◽

New Drug ◽

Number Of Patients ◽

The Us ◽

Us Fda ◽

New Drug Application

Download Full-text

Hi-Tech Pharmacal's Abbreviated New Drug Application (ANDA) for fluticasone propionate nasal spray 50??g has been granted final approval by the US FDA.

Inpharma Weekly ◽

10.2165/00128413-200816220-00088 ◽

2008 ◽

Vol &NA; (1622) ◽

pp. 22

Author(s):

&NA;

Keyword(s):

Fluticasone Propionate ◽

Nasal Spray ◽

Drug Application ◽

Final Approval ◽

New Drug ◽

The Us ◽

Us Fda ◽

New Drug Application

Download Full-text

The US FDA has granted tentative approval for Mylan Pharmaceuticals' Abbreviated New Drug Application for delayed-release rabeprazole

Inpharma Weekly ◽

10.2165/00128413-200615220-00050 ◽

2006 ◽

Vol &NA; (1522) ◽

pp. 18

Author(s):

&NA;

Keyword(s):

Drug Application ◽

New Drug ◽

Delayed Release ◽

The Us ◽

Tentative Approval ◽

Us Fda ◽

New Drug Application

Download Full-text

The US FDA has granted tentative approval to Teva Pharmaceutical's Abbreviated New Drug Application (ANDA) for lansoprazole.

Inpharma Weekly ◽

10.2165/00128413-200816230-00071 ◽

2008 ◽

Vol &NA; (1623) ◽

pp. 19

Author(s):

&NA;

Keyword(s):

Drug Application ◽

New Drug ◽

The Us ◽

Tentative Approval ◽

Us Fda ◽

New Drug Application

Download Full-text

Banner Pharmacaps has received approval from the US FDA for its Abbreviated New Drug Application (ANDA) for nimodipine 30mg soft gelatin capsules.

Inpharma Weekly ◽

10.2165/00128413-200816230-00057 ◽

2008 ◽

Vol &NA; (1623) ◽

pp. 17 ◽

Author(s):

&NA;

Keyword(s):

Drug Application ◽

Gelatin Capsules ◽

New Drug ◽

Soft Gelatin Capsules ◽

The Us ◽

Us Fda ◽

New Drug Application

Download Full-text

Endo Pharmaceuticals received a "not approvable" letter from the US FDA regarding their supplemental New Drug Application for frovatriptan [Frova]

Inpharma Weekly ◽

10.2165/00128413-200716090-00069 ◽

2007 ◽

Vol &NA; (1609) ◽

pp. 23

Author(s):

&NA;

Keyword(s):

Drug Application ◽

Approvable Letter ◽

New Drug ◽

The Us ◽

Us Fda ◽

New Drug Application

Download Full-text

Teva Pharmaceutical's Abbreviated New Drug Application (ANDA) for pravastatin 80mg tablets has been granted final approval by the US FDA.

Inpharma Weekly ◽

10.2165/00128413-200816220-00090 ◽

2008 ◽

Vol &NA; (1622) ◽

pp. 22

Author(s):

&NA;

Keyword(s):

Drug Application ◽

Final Approval ◽

New Drug ◽

The Us ◽

Us Fda ◽

New Drug Application

Download Full-text

Mylan Pharmaceuticals' Abbreviated New Drug Application for fluoxetine 10mg and 20mg capsules has been granted tentative approval by the US FDA

Inpharma Weekly ◽

10.2165/00128413-200615540-00070 ◽

2006 ◽

Vol &NA; (1554) ◽

pp. 22

Author(s):

&NA;

Keyword(s):

Drug Application ◽

New Drug ◽

The Us ◽

Tentative Approval ◽

Us Fda ◽

New Drug Application

Download Full-text

APP Pharmaceuticals' Abbreviated New Drug Application (ANDA) for injectable polymyxin B (500 000 units/vial) has been approved by the US FDA.

Inpharma Weekly ◽

10.2165/00128413-200816220-00086 ◽

2008 ◽

Vol &NA; (1622) ◽

pp. 21

Author(s):

&NA;

Keyword(s):

Drug Application ◽

Polymyxin B ◽

New Drug ◽

The Us ◽

Us Fda ◽

New Drug Application

Download Full-text

Merck & Co has received a not approvable letter for its New Drug Application for OTC lovastatin [Mevacor OTC] 20mg from the US FDA.

Inpharma Weekly ◽

10.2165/00128413-200816230-00063 ◽

2008 ◽

Vol &NA; (1623) ◽

pp. 18

Author(s):

&NA;

Keyword(s):

Drug Application ◽

Approvable Letter ◽

New Drug ◽

The Us ◽

Us Fda ◽

New Drug Application

Download Full-text

APP Pharmaceuticals' Abbreviated New Drug Application for 20 mg/mL caffeine citrate oral solution has been approved by the US FDA.

Inpharma Weekly ◽

10.2165/00128413-200816250-00066 ◽

2008 ◽

Vol &NA; (1625) ◽

pp. 22

Author(s):

&NA;

Keyword(s):

Drug Application ◽

Oral Solution ◽

New Drug ◽

The Us ◽

Caffeine Citrate ◽

Us Fda ◽

New Drug Application

Download Full-text