Oxymetazoline Hydrochloride and Rucaparib Camsylate

• Generic Name: oxymetazoline ophthalmic
• Dosage Forms: n.a.
• Other Brand Names: Visine LR, Visine Long Lasting, Ocuclear

Self-medication for temporary relief of nasal congestion associated with the common cold, hay fever, or other upper respiratory allergies.

As effective as other topical vasoconstrictors.

Labeled and has been used for self-medication for temporary relief of nasal congestion associated with sinusitis; however, efficacy data are lacking and/or controversial. In October 2005, FDA issued final rule to remove this indication from labeling of OTC nasal decongestants. Compliance date for preparations with annual sales <$25,000 is October 11, 2007; compliance date for all other preparations is April 11, 2007.

Self-medication for temporary relief of ocular redness due to minor irritation.

Has been used for self-medication for symptomatic prevention of otitic barotrauma (aerotitis [barotitis] media); however, no more effective than placebo.

• Generic Name: rucaparib
• Dosage Forms: n.a.
• Other Brand Names: Rubraca

Single-agent therapy for the treatment of deleterious germline and/or somatic BRCA-mutated (as detected by an FDA-approved companion diagnostic test [FoundationFocus CDx BRCA]) advanced ovarian cancer previously treated with ≥2 chemotherapy regimens (designated an orphan drug by FDA for this use). Subgroup analysis suggests overall response rate is higher in patients with platinum-sensitive disease than in those with platinum-resistant disease (66 versus 25%); no responses observed in a limited number of patients with platinum-refractory disease.

Accelerated approval based on overall response rate and duration of response. Continued approval may be contingent on verification and description of clinical benefit in confirmatory studies.

Women with mutations that result in defective BRCA genes are more likely to develop ovarian cancer. Approximately 10–15% of all cases of ovarian cancer appear to be associated with these hereditary BRCA mutations.