OMNICEF (nda050739)- (300MG)

Generic Name	CEFDINIR	Innovator	ABBVIE
Dosage	300MG
ParaIV Filing	No	505(b)2 Filing	No
Last Patent Expiry	2011-Dec-04	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	OMNICEF (cefdinir) capsules and OMNICEF (cefdinir) for oral suspension are indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the conditions listed below: 1) Adults and Adolescents:- *Community-Acquired Pneumonia caused by Haemophilus influenzae (including β-lactamase producing strains), Haemophilus parainfluenzae (including β-lactamase producing strains), Streptococcus pneumoniae (penicillin-susceptible strains only), and Moraxella catarrhalis (including βlactamase producing strains). * Acute Exacerbations of Chronic Bronchitis caused by Haemophilus influenzae (including β-lactamase producing strains), Haemophilus parainfluenzae (including β-lactamase producing strains), Streptococcus pneumoniae (penicillin-susceptible strains only), and Moraxella catarrhalis (including βlactamase producing strains). * Acute Maxillary Sinusitis caused by Haemophilus influenzae (including β-lactamase producing strains), Streptococcus pneumoniae (penicillin-susceptible strains only), and Moraxella catarrhalis (including β-lactamase producing strains). * Pharyngitis/Tonsillitis caused by Streptococcus pyogenes. * Uncomplicated Skin and Skin Structure Infections caused by Staphylococcus aureus (including β-lactamase producing strains) and Streptococcus pyogenes. 2) Pediatric Patients:- * Acute Bacterial Otitis Media caused by Haemophilus influenzae (including β-lactamase producing strains), Streptococcus pneumoniae (penicillin-susceptible strains only), and Moraxella catarrhalis (including β-lactamase producing strains). * Pharyngitis/Tonsillitis caused by Streptococcus pyogenes. * Uncomplicated Skin and Skin Structure Infections caused by Staphylococcus aureus (including β-lactamase producing strains) and Streptococcus pyogenes.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
6	0	5

Other Developers

Total Other Developers	None

Drugs with Suitability

Drugs with Suitability	No

Drug Pricing

	NDA			ANDA
Dosage	Weekly	Monthly	Yearly	Yearly Up	Yearly Down
300MG	**	**	-	-	4

Drug Sales

NDA Sales Available	Total Generic Sales Available
No	5

Manufacturing Details of OMNICEF