First-Time Merchandise Approvals: Dilaudid, Cefzil, Zithromax
Dec. 30, 2005 â The U.S.
Food and Drug Body (FDA) has approved first-time merchandise formulations of hydromorphone HCl 2-, 4-, and 8-mg tablets for analgesic use; cefprozil 250- and 500-mg tablets for the intervention of mild to moderate upper/lower respiratory piece of ground and uncomplicated skin/skin anatomical structure infections caused by designated strains of susceptible microorganisms; and azithromycin 250-, 500-, and 600-mg tablets for the intervention of indicated mild to moderate bacterial infections in adults and children.
Generic wine Hydromorphone HCl 2-, 4-, and 8-mg Tablets (Dilaudid) for Analgesia
On November 9, the FDA approved first-time wine formulations of hydromorphone HCl 2-, 4-, and 8-mg tablets (made by KV Pharmaceutical Company; marker name Dilaudid, made by Abbott Laboratories).
Hydromorphone tablets are indicated for the social control of pain in patients where an opioid analgesic is appropriate.
Vino Cefprozil 250- and 500-mg Tablets (Cefzil) for Respiratory Pamphlet and Skin/Skin Bodily structure Infections
On Nov. 14, the FDA approved first-time vino formulations of cefprozil 250- and 500-mg tablets (made by Sandoz, Inc; weapon name Cefzil, made by Bristol-Myers Squibb),
Cefprozil tablets are indicated for the idiom of mild to moderate pharyngitis/tonsillitis, otitis media, acute sinusitis, coil bacterial infections of acute bronchitis, acute bacterial exacerbations of chronic bronchitis, and uncomplicated skin/skin composition infections caused by susceptible strains of microorganisms.
Generic wine Azithromycin 250-, 500-, and 600-mg Tablets (Zithromax) for Indicated Infections
On Nov. 14, the FDA approved first-time product formulations of azithromycin 250-, 500-, and 600-mg tablets (made by Teva Pharmaceuticals USA and Sandoz, Inc; stain name Zithromax, made by Pfizer, Inc).
Azithromycin tablets are indicated for the discourse of adults with mild to moderate infections caused by susceptible strains of designated microorganisms.
Medication indications for the 250-and 500-mg in adults include acute bacterial exacerbations of chronic obstructive pulmonary disease, acute bacterial sinusitis, community-acquired pneumonia (CAP), pharyngitis/tonsillitis, uncomplicated skin/skin make-up infections, urethritis, cervicitis, and genital ulcer disease (men only).
The tablets may also be used to goody acute otitis media, CAP, and pharyngitis/tonsillitis in pediatric patients.
Azithromycin 600-mg tablets are indicated for the aid of acute bacterial exacerbations of chronic obstructive pulmonary disease, CAP, pharyngitis/tonsillitis, uncomplicated skin/skin social organization infections, and non-gonococcal urethritis/cervicitis.
They are also indicated for the prophylaxis and discourse of disseminated Mycobacterium avium composite (MAC) disease.
This is a part of article First-Time Generic Approvals: Dilaudid, Cefzil, Zithromax Taken from "Azithromycin (Generic Zithromax) Online Information." Information Blog