FDA

FDA and European Medicines Agency launch generic drug application inspections initiative

The U.S. Food and Drug Administration has released the following news item:

The U.S. Food and Drug Administration and the European Medicines Agency (EMA) have announced the launch of a joint initiative to share information on inspections of bioequivalence studies submitted in support of generic drug approvals. This collaborative effort provides a mechanism to conduct joint facility inspections for generic drug applications submitted to both agencies.

Abrams Royal Pharmacy Issues Voluntary Recall

Sterility concerns have prompted Abrams Royal Pharmacy to voluntarily recall all unexpired lots of sterile products dispensed nationwide, including injectable medications, IVs, eye drops, pellet implants, nasal sprays, inhalation solutions, and eye ointments, FDA reported on its Web site

FDA Issues Strategic Plan to Address Drug Shortages

In an effort to lessen the impact drug shortages have on public health, FDA has published a strategic plan to improve the agency’s response to imminent or existing shortages and to develop longer-term approaches for addressing the underlying causes of such shortages, the agency reported on its Web site

FDA Releases Final Unique Device Identification Rule

FDA has finalized its Unique Device Identification (UDI) regulation intended to drive consistency in medical device identification. The final rule requires that most medical devices distributed in the United States bear a unique device identifier, the agency posted on its UDI page today.

FDA Releases Draft Guidance on Good Lab Practices

[Targeted News Service] ARLINGTON, Va., Aug. 28 -- The Association for the Advancement of Medical Instrumentation issued the following news release:

Ceptaris Receives FDA Approval for Valchlor

[Global Data Point]--Ceptaris Therapeutics, Inc., a privately held, specialty pharmaceutical company, announced today that the U.S. Food and Drug Administration (FDA) has granted marketing approval for the orphan drug VALCHLOR™ (mechlorethamine) gel for the topical treatment of stage IA and IB mycosis fungoides-type cutaneous T-cell lymphoma (CTCL) in patients who have received prior skin-directed therapy.

FDA Clears Spartan Bio Rapid DNA Test

Ottawa, Ontario (PRWEB)--Spartan Bioscience today announced that the U.S. Food and Drug Administration (FDA) granted 510(k) clearance permitting marketing of the Spartan RX CYP2C19 System. It provides genetic results in less than 60 minutes from a non-invasive cheek swab.

Galderma Receives FDA Approval of Mirvaso

FT. WORTH, Texas--(BUSINESS WIRE)-- Galderma Laboratories, L.P. today announced that the U.S. Food and Drug Administration (FDA) has approved Mirvaso (brimonidine) topical gel, 0.33% for the topical treatment of the facial erythema (redness) of rosacea in adults 18 years of age or older.

Tris Pharma Attains Approval for Extended-release Oral Suspension Allergy Drug

The drug is indicated for seasonal and perennial allergic rhinitis in children ages two and up.

Tris Pharma, a specialty pharmaceutical company focused on developing innovative drug delivery technologies, today announced that the U.S. Food and Drug Administration (FDA) has approved its New Drug Application (NDA) for Karbinal™ ER (carbinoxamine maleate) Extended-release Oral Suspension 4mg/5ml, the first sustained-release histamine receptor blocking agent indicated for the treatment of seasonal and perennial allergic rhinitis in children ages 2 and up.

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Merck Attains Acceptance for Investigational Grass Pollen Allergy Immunotherapy Tablet

The company has received FDA investigational approval for biologics intended to treat Timothy grass and ragweed pollen.

Merck, known as MSD outside the United States and Canada, today announced that the Biologics License Application (BLA) for its investigational Timothy grass pollen (Phleum pratense) allergy immunotherapy tablet (AIT) has been accepted for review by the U.S. Food and Drug Administration (FDA). In March, the company also submitted a BLA to the FDA for its investigational ragweed pollen (Ambrosia artemisiifolia) AIT. 

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