Sagent Pharma recalls three lots of ketorolac tromethamine injection due to incorrect labels Schaumburg, Illinois, Oct 2014: Sagent Pharmaceuticals, a specialty pharmaceutical company focused on developing, manufacturing, sourcing and marketing pharmaceutical products, announced the voluntary nationwide recall of three lots of ketorolac tromethamine injection, USP, 30mg/mL single-dose vials (NDC numbers 25021-701-01 and 25021-701-02) manufactured by Cadila Healthcare Limited and distributed by Sagent. Sagent has initiated this voluntary recall of ketorolac tromethamine injection, USP, 30mg/mL to the user level due to labelling the product with the incorrect expiration date. The labelled expiration date is longer than the known stability of the product.
US FDA approves Regeneron's Eylea injection to treat macular edema following RVO New York, October 2014: Regeneron Pharmaceuticals announced that the US Food and Drug Administration (US FDA) has approved Eylea (aflibercept) injection for the treatment of macular edema following retinal vein occlusion (RVO), which includes macular edema following branch retinal vein occlusion (BRVO) in addition to the previously-approved indication of macular edema following central retinal vein occlusion (CRVO). The recommended dosage of Eylea in patients with macular edema following RVO is 2 milligrams (mg) every month (4 weeks). "RVO is a significant cause of vision impairment in the US, and this expanded indication across all forms of RVO will provide an important new treatment option for retina specialists and their patients," said George D. Yancopoulos, chief scientific officer of Regeneron and president of Regeneron Laboratories. "Regeneron remains committed to studying Eylea for the treatment of multiple VEGF-driven retinal diseases."
FDA Approves Uceris (budesonide) Rectal Foam for Ulcerative Colitis
RALEIGH, N.C., October 2014 : Salix Pharmaceuticals, Ltd. (NASDAQ:SLXP) today announced that the Food and Drug Administration (FDA) has granted final approval for Uceris (budesonide) rectal foam for the induction of remission in patients with active mild-to-moderate distal ulcerative colitis (UC) extending up to 40cm from the anal verge. The foam is a rectally administered corticosteroid that overcomes treatment limitations associated with currently approved therapies which are often ineffective due to insufficient distribution of active drug to the distal colon.
Frequently Asked Questions Q1. What are ophthalmic preparations?
Answer: Ophthalmic preparations (eye preparations) are sterile, liquid, semi-solid, or solid preparations that may contain one or more active pharmaceutical ingredient(s) intended for application to the eyes (conjunctiva, the conjunctival sac or the eyelids). The different categories of ophthalmic preparations include drops consisting of emulsions, solutions or suspensions, and ointments. Ophthalmic preparations should maintain their integrity throughout their shelf-life when stored at the temperature indicated on the label. Special storage recommendations or limitations are indicated in individual monographs.
Q2. What are the important instructions that should be remembered while administering such preparations?
Answer: The eye is extremely sensitive and is easily irritated if the composition of the ophthalmic preparation is not appropriate. Eye drops come in single use containers and in multiple dose bottles. Multidose eye drops labelling instruction recommends - To be use within one month (30 days) after opening the container which needs to be followed carefully as they are sterile formulations, but as soon as patients open the bottle for first time, the formulation get exposed to external environment and have high chance of contamination. Moreover, inadvertently dropper tips often touch the eyelids or countertops during use and can contaminate the bottle with bacteria. Preservatives are added to a certain quantity to prevent the solution from external and in inadvertent contamination only up to 30 days. So patient should discard any unused eye drop after 30 days.
Therefore a kind note from PSM Desk that next time you use eye drop/ointment, be careful and diligent in following every instructions as eyes are un-doubted the most vital part of our body.