The FDA has determined that 3 generic formulations of levothyroxine are therapeutically equivalent to brand-name formulations. Some brand-name manufacturers have objected, and endocrine organizations have expressed their concern.
See levothyroxine addendum

The FDA has approved pegaptanib sodium (Macugen - Pfizer/Eyetech) as an intravitreous injection for treatment of all subtypes of neovascular (wet) age-related macular degeneration (AMD). The only other approved treatment for this condition is photodynamic therapy with intravenous verteporfin (Visudyne), which is recommended only for patients with one subtype (predominantly classic) of neovascular AMD.

A live attenuated varicella-zoster vaccine (Zostavax - Merck) has been approved by the FDA for prevention of herpes zoster (HZ; zoster; shingles) in persons ≥60 years old. Each dose of Zostavax contains about 14 times as much varicella-zoster virus (VZV) as Varivax, which has been used in the US since 1995 to vaccinate against varicella (chicken pox).

Some patients with primary immune deficiency are injected with intravenous immune globulin (IVIG) every 3-4 weeks. Now a subcutaneous immune globulin (SCIG) has also been approved in the US for this indication (Vivaglobin - CSL Behring). SCIG has been used in Europe for about 10 years.

Several injectable products are available for soft tissue augmentation of wrinkles and folds. These fillers are often used in conjunction with botulinum toxin type A (Botox) injections.

Mecasermin (Increlex - Tercica), which is injected subcutaneously, has been approved by the FDA for treatment of growth failure in children with severe primary insulin-like growth factor (IGF-1) deficiency. Mecasermin is recombinant human (rh) IGF-1. It has also been approved to treat children with short stature who are deficient in growth hormone (GH), but have developed neutralizing antibodies in response to GH treatment. A similar product, mecasermin rinfabate (Iplex - Insmed), that was approved by the FDA for the same indications was withdrawn from the market due to patent...

Lubiprostone (Amitiza), which was previously approved for treatment of chronic idiopathic constipation in adults, has now also been approved in a lower dose for use in women with irritable bowel syndrome with constipation (IBS-C). Since tegaserod (Zelnorm) has been withdrawn from the market,2 lubiprostone is the only drug approved by the FDA for treatment of this common condition.

The EarCheck Middle Ear Monitor (Innovia Medical) is a device marketed to consumers for home detection of middle-ear effusion (MEE) in children.

The FDA has approved subcutaneous injection of methylnaltrexone (Relistor - Wyeth/Progenics), a selective mu-opioid receptor antagonist, for treatment of opioid-induced constipation in patients with advanced illness (such as incurable cancer or end-stage chronic obstructive pulmonary disease) who are receiving palliative care.

Rotarix, an oral live-attenuated rotavirus vaccine, has been approved by the FDA for prevention of rotavirus gastroenteritis in infants and children. Rota-Shield was withdrawn from the market because of an association with intussusception. RotaTeq, an oral live, human-bovine reassortant rotavirus vaccine, is recommended by the American Academy of Pediatrics as a routine immunization.